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Clinical question: Does cardiac rehabilitation improve quality of life for a man with coronary artery disease who received percutaneous transluminal coronary angioplasty with insertion of a stent?


The purpose of "Evidence in Practice" is to illustrate how evidence is gathered and used to guide clinical decision making. This article is not a case report. The examination, evaluation, and intervention sections are purposely abbreviated.

A 48-year-old man developed severe anterior chest pressure with pain radiating to the left arm in the morning and was sent to the emergency department. Both his serum creatinine creatinine /cre·at·i·nine/ (kre-at´i-nin) an anhydride of creatine, the end product of phosphocreatine metabolism; measurements of its rate of urinary excretion are used as diagnostic indicators of kidney function and muscle mass.  phosphokinase and creatinine phosphokinase-MB band levels were elevated significantly, and an elevated plasma troponin I troponin I
n.
A subunit of troponin found in muscle and cartilage that inhibits the formation of blood vessels and is under investigation as a potential cancer therapy.
 level (14.1 IU) also was noted.

The electrocardiogram electrocardiogram /elec·tro·car·dio·gram/ (-kahr´de-o-gram?) a graphic tracing of the variations in electrical potential caused by the excitation of the heart muscle and detected at the body surface.  (ECG ECG electrocardiogram.

ECG
abbr.
1. electrocardiogram

2. electrocardiograph


ECG
Also called an electrocardiogram, it records the electrical activity of the heart.
) confirmed the evolution of an extensive anteroseptal myocardial infarction myocardial infarction: see under infarction.  (MI). He then was transferred to the intensive care unit where 100 mg of tissue plasminogen activator tissue plasminogen activator
n. Abbr. TPA
1. An enzyme that catalyzes the conversion of plasminogen to plasmin, used to dissolve blood clots rapidly and selectively, especially in the treatment of heart attacks.

2.
 was administered, followed by a heparin drip; his chest pain subsided with only intermittent episodes thereafter. Monitoring with ECG revealed occasional episodes of ventricular tachycardia Ventricular Tachycardia Definition

Ventricular tachycardia (V-tach) is a rapid heart beat that originates in one of the lower chambers (the ventricles) of the heart.
, and congestive heart failure congestive heart failure, inability of the heart to expel sufficient blood to keep pace with the metabolic demands of the body. In the healthy individual the heart can tolerate large increases of workload for a considerable length of time.  was suspected. After medical treatment in the intensive care unit, the patient rarely experienced any chest pain and had a normal sinus rhythm sinus rhythm
n.
A normal cardiac rhythm proceeding from the sinoatrial node.
.

Three days later, cardiac catheterization Cardiac Catheterization Definition

Cardiac catheterization (also called heart catheterization) is a diagnostic procedure which does a comprehensive examination of how the heart and its blood vessels function.
 was performed, which revealed a 90% occlusion occlusion /oc·clu·sion/ (o-kloo´zhun)
1. obstruction.

2. the trapping of a liquid or gas within cavities in a solid or on its surface.

3.
 of the left anterior descending artery at the second diagonal, a 50% occlusion of the mid-right coronary artery coronary artery
n.
1. An artery with origin in the right aortic sinus; with distribution to the right side of the heart in the coronary sulcus, and with branches to the right atrium and ventricle, including the atrioventricular branches and
, a 50% occlusion of a diagonal artery of the circumflex circumflex /cir·cum·flex/ (serk´um-fleks) curved like a bow.

cir·cum·flex
adj.
1. Curving or bending around.

2. Bowed.



circumflex

curved like a bow.
 artery, and left ventricular dysfunction ventricular dysfunction,
n an abnormality in contraction and wall motion within the ventricles.
 (left ventricular ejection fraction ejection fraction
n.
The blood present in the ventricle at the end of diastole and expelled during the contraction of the heart.


Ejection fraction 
 of 40%). His New York Heart Association classification New York Heart Association classification A functional classification of cardiac failure, used to stratify Pts according to severity of disease and the need for–and type of–therapeutic intervention

 was functional class I. A percutaneous transluminal coronary angioplasty percutaneous transluminal coronary angioplasty
n. Abbr. PTCA
A procedure for enlarging a narrowed arterial lumen by peripheral introduction of a balloon-tip catheter followed by dilation of the lumen as the inflated catheter tip is
 (PTCA PTCA
abbr.
percutaneous transluminal coronary angioplasty


PTCA Percutaneous transluminal coronary angioplasty, see there
) with the insertion of a stent in the occluded left anterior descending artery was successfully performed on the same day. Two days later, the patient was discharged with the following medications prescribed: calcium channel blockers Calcium Channel Blockers Definition

Calcium channel blockers are medicines that slow the movement of calcium into the cells of the heart and blood vessels.
 (diltiazem, 60 mg 3 times a day), antiplatelet agents (aspirin, 100 mg every day), and nitrates (sublingual sublingual /sub·lin·gual/ (-ling´gwal) hypoglossal; beneath the tongue.

sub·lin·gual
adj. Abbr. SL
Below or beneath the tongue; hypoglossal.
 nitroglycerin nitroglycerin (nī'trōglĭs`ərĭn), C3H5N3O9, colorless, oily, highly explosive liquid. It is the nitric acid triester of glycerol and is more correctly called glycerol trinitrate.  as required). His cardiologist did not prescribe a beta-blocker because of concern about his past history of bronchial asthma bronchial asthma
n.
A condition of the lungs characterized by widespread narrowing of the airways due to spasm of the smooth muscle, edema of the mucosa, and the presence of mucus in the lumen of the bronchi and bronchioles.
. The patient's condition significantly improved after PTCA; he could perform daily activities with no symptoms. He returned to work 1 month after the MI.

One month after the PTCA procedure, the patient was referred to the cardiac rehabilitation Cardiac Rehabilitation Definition

Cardiac rehabilitation is a comprehensive exercise, education, and behavioral modification program designed to improve the physical and emotional condition of patients with heart disease.
 phase II program in our outpatient physical therapy department after a symptom-limited maximal exercise test. The exercise test using a cycle ergometer ergometer /er·gom·e·ter/ (er-gom´e-ter) a dynamometer.

bicycle ergometer  an apparatus for measuring the muscular, metabolic, and respiratory effects of exercise.
 revealed a poor exercise tolerance with a maximal workload of 50 W and a peak work capacity of 3.6 metabolic equivalents, and the test ended with dyspnea dyspnea /dysp·nea/ (disp-ne´ah) labored or difficult breathing.dyspne´ic

paroxysmal nocturnal dyspnea
 and leg fatigue without angina or ST-segment changes.

** Examination and evaluation: Physical examination revealed that the patient had stable vital signs without any discomfort during daily activities. According to according to
prep.
1. As stated or indicated by; on the authority of: according to historians.

2. In keeping with: according to instructions.

3.
 the patient, his health status was very good before his MI, and no dyspnea or any kind of cardiopulmonary cardiopulmonary /car·dio·pul·mo·nary/ (kahr?de-o-pool´mah-nar-e) pertaining to the heart and lungs.

car·di·o·pul·mo·nar·y
adj.
Of, relating to, or involving both the heart and the lungs.
 discomfort occurred before this episode of MI. From his history, however, the patient had positive risk factor profiles for coronary artery disease coronary artery disease, condition that results when the coronary arteries are narrowed or occluded, most commonly by atherosclerotic deposits of fibrous and fatty tissue.  (CAD): he had a family history of CAD (his father and mother both died from MIs at 53 years and 59 years of age, respectively), he had smoked 2.5 to 3 packs of cigarettes per day for more than 30 years, and he was obese (body mass index=30.4 kg/[m.sup.2]).

This patient worked as a counseling manager in a personal private business. Before the MI, he worked long hours each day (ie, 12 hours every day for 5 or 7 days a week). According to the patient, the psychological stress imposed by his work was greater than its physical demands. He also had to drive 5 km to work every day, and he resided in a 6-story building, which had an elevator available. For recreation, he occasionally went hiking if he did not have to work during the weekend. He, therefore, lived a relatively sedentary lifestyle
For anthropology, see sedentism.


Sedentary lifestyle is a type of lifestyle most commonly found in modern (particularly Western) cultures. It is characterized by sitting or remaining inactive for most of the day (for example, in an office.
 with minimal physical demands. He lived with his wife who had her own career. They had no children; therefore, according to the patient, family life caused no stress.

Based on these findings, we concluded that the patient's major problem was insufficient cardiopulmonary capacity. We decided to implement a treatment program that we use routinely in our department for people with CAD who received PTCA and a stent. The patient immediately started an exercise training program on a cycle ergometer that consisted of a 5-minute warm-up period with workloads of 10 W, a 15-minute training period with workloads of 20 W, and a 5-minute cool-down of 10 W. The training frequency was three 30-minute sessions per week, with the training intensity gradually increasing according to the patient's tolerance, following the American College of Sports Medicine '''Founded in 1954, the AMERICAN COLLEGE OF SPORTS MEDICINE is the largest sports medicine and exercise science organization in the world. More than 20,000 international, national and regional members are dedicated to advancing and integrating scientific research to provide educational  guidelines. (1)

The patient also received education regarding atherosclerotic heart disease atherosclerotic heart disease Cardiology A general term for the progressive narrowing and hardening of coronary arteries, due to atheroma deposition which, with time undergo calcification and ulceration Risk of progression ↑ Cholesterol, HTN, smoking, DM, , risk factors, and exercise precautions. During the initial training session, the patient's diastolic blood pressure Diastolic blood pressure
Blood pressure when the heart is resting between beats.

Mentioned in: Hypertension
 remained consistently high (96 to 98 mm Hg) both at rest and during exercise. The primary physician thus decided to increase the dose of calcium channel blockers (diltiazem, 90 mg 3 times a day).

After the initial training session, this patient was asymptomatic at rest and exhibited normal blood pressure and heart rate responses during exercise training. He seemed to understand the benefits of the cardiac rehabilitation phase II program and was highly motivated to accomplish the program.

Six weeks after the PTCA procedure, however, he experienced an episode of chest tightness during his busy office hours office hours,
n.pl See business hours.
 that caused him to worry about his health. He went to his cardiologist, who told him that the thallium thallium (thăl`ēəm), metallic chemical element; symbol Tl; at. no. 81; at. wt. 204.383; m.p. 303.5°C;; b.p. about 1,457°C;; sp. gr. 11.85 at 20°C;; valence +1 or +3.  201 imaging showed no evidence of restenosis of the coronary arteries Coronary arteries
The two main arteries that provide blood to the heart. The coronary arteries surround the heart like a crown, coming out of the aorta, arching down over the top of the heart, and dividing into two branches.
 and that the chest tightness might due to occasional vasospasm vasospasm /vaso·spasm/ (va´zo-) (vas´o-spazm) angiospasm; spasm of blood vessels, causing vasoconstriction.vasospas´tic

va·so·spasm
n.
. His cardiologist prescribed dipyridamole dipyridamole /di·py·rid·a·mole/ (di?pi-rid´ah-mol) a platelet inhibitor and coronary vasodilator used to prevent thromboembolism associated with mechanical heart valves, to treat transient ischemic attacks, and as an adjunct in  (Persantine, * 75 mg 3 times a day) for dilation dilation /di·la·tion/ (di-la´shun)
1. the act of dilating or stretching.

2. dilatation.


di·la·tion
n.
1.
 of the coronary arteries and for anticoagulation and recommended that he continue exercise training with regular follow-ups.

Since the episode of chest tightness, this patient continued to be anxious about his health. The patient's quality of life (QOL QOL,
n quality of life, a subjective assessment of one's emotional and physical well-being.
) was affected by these concerns, which included the possible recurrence of chest tightness, possible restenosis, and possible hospital readmission readmission Managed care The admission of a Pt to a health care facility for a condition–eg, stroke, MI, GI bleeding, hip fracture, cancer surgery, shortly after discharge. See nth admission. Cf Admission, Discharge. . He started to wonder if the cardiac rehabilitation program would be able to improve his cardiac dysfunction and accommodate his busy work schedule at the same time. Because the patient was in the prime of his life, he was much concerned about his future QOL.

Before answering his questions, we decided to search the literature to see if there was evidence demonstrating that the outpatient cardiac rehabilitation phase II program could improve his QOL by promoting physical well-being and reducing anxiety.

** Databases used for search: MEDLINE The online medical database of the U.S. National Library of Medicine (NLM) whose parent is the National Institutes of Health, Bethesda, MD. MEDLINE contains millions of articles from thousands of medical journals and publications. The consumer section of the site (http://medlineplus. , CINAHL CINAHL Cumulative Index to Nursing and Allied Health Literature

Because we wanted to access literature from medical journals as well as journals dealing specifically with physical rehabilitation physical rehabilitation See Physical therapy. , we first used the MEDLINE database. We accessed MEDLINE through its online version, PubMed, at www.ncbi.nlm.nih. gov/PubMed. In addition, we wondered whether literature from another database such as CINAHL (Cumulative Index to Nursing and Allied Health Literature) might include journals dealing with physical activity and rehabilitation. We accessed CINAHL through Ovid ([dagger]) (gateway.ut.ovid.com/gw2/ovidweb. cgi). Unfortunately, the CINAHL database did not provide any pertinent information on this topic. Thus, we report only the search procedure from MEDLINE, which was performed on June 24, 2006.

** Initial Keywords: cardiac rehabilitation, exercise training, PTCA

We started the search using 3 keywords in the following search string: (cardiac rehabilitation OR exercise training) AND PTCA. The initial results listed 171 articles. Because the number of hits was somewhat large and might cover broader effects of cardiac rehabilitation or exercise training on patients after PTCA, we added another keyword "quality of life," our patient's major concern, to our search string. The final search string was (cardiac rehabilitation OR exercise training) AND PTCA AND quality of life. Thirty-one articles relevant to our question were retrieved.

We then added limits to our search. Because of recent advances in the PTCA procedure, especially the use of stents, we limited the search by entering the dates 1999 and 2006 in the Entry Date field in PubMed's Limits feature. We also restricted the search to articles that were published in English and that described studies on people rather than animals. The number of search results was reduced to 19.

A cursory look suggested that most of these articles dealt with the issues relevant to QOL after PTCA. It appeared that we were on the right track, and the total number of articles did not seem to be overwhelming. Rather than imposing further limits or using additional keywords, we began to examine each article. The citations from these articles are listed in Figure 1.
Figure 1. Citations retrieved by search using the search string
(cardiac rehabilitation OR exercise training) AND PTCA AND quality of
life.

1. Paquet M, Bolduc N, Xhignesse M, Vanasse A. Re-engineering
cardiac rehabilitation programmes: considering the patient's point
of view. J Adv Nuts. 2005;51:567-576.

2. Yu CM, Lau CP, Chau J, et al. A short course of cardiac
rehabilitation program is highly cost effective in improving long-term
quality of life in patients with recent myocardial infarction or
percutaneous coronary intervention. Arch Phys Med Rehabil. 2004;85:
1915-1922.

3. Evon DM, Burns JW. Process and outcome in cardiac rehabilitation:
an examination of cross-lagged effects. J Consult Clin Psychol.
2004;72:605-616.

4. Reddy. BK, Brewster PS, Walsh T, et al. Randomized comparison
of rapid ambulation using radial, 4 French femoral access, or
femoral access with AngioSeal closure. Catheter Cardiovasc Interv.
2004;62:143-149.

5. Muller-Nordhorn J, Roll S, Willich SN. Comparison of the short
form (SF)-12 health status instrument with the SF-36 in patients with
coronary heart disease. Heart. 2004;90:523-527.

6. Eisenberg MJ, Blankenship JC, Huynh T, et al; ADORE Investigators.
Evaluation of routine functional testing after percutaneous
coronary intervention. Am J Cardiol. 2004;93:744-747.

7. Gardner JK, McConnell TR, Klinger TA, et al. Quality of life and
self-efficacy: gender and diagnoses considerations for management
during cardiac rehabilitation. J Cardiopulm Rehabil. 2003;23:
299-306.

8. Stewart KJ, Badenhop D, Brubaker PH et al. cardiac rehabilitation
following perculaneous revascularization, heart transplant,
heart valve surgery, and for chronic heart failure. Chest.
2003;123:2104-2111.

9. Pasquali SK, Alexander KP, Coombs LP, et al. Effect of cardiac
rehabilitation on functional outcomes after coronary revascularization.
Am Heart J. 2003; 145:445-451.

10. Hevey D, Brown A, Cahill A et al. Four-week multidisciplinary
cardiac rehabilitation produces similar improvements in exercise
capacity and quality of life to a 10-week program. J Cardiopulm
Rehabil. 2003;23:17-21.

11. Raine RA, Black NA, Bowker TJ, Wood DA. Gender differences in
the management and outcome of patients with acute coronary
artery disease. J Epidemiol Community Health. 2002;56:
791-797.

12. Jamieson M, Wilcox S, Webster W, et al. Factors influencing
health-related quality of life in cardiac rehabilitation patients. Prog
Cardiavasc Nuts. 2002; 17:124-131, 154.

13. Pilote L, Lauzon C, Huynh T, et al. Quality of life after acute
myocardial infarction among patients treated at sites with and
without on-site availability of angiography. Arch Intern Med.
2002; 162:553-559.

14. Bengtsson I, Hagman M, Wedel H. Age and angina as predictors
of quality of life after myocardial infarction: a prospective
comparative study. Scand Cardiavasc J. 2001;35:252-258.

15. Belardinelli R, Paolini I, Cianci G, el al. Exercise training
intervention after coronary angioplasty: the ETICA trial. J Am Coll
Cardiol. 2001;37:1891-1900.

16. Pocock SJ, Henderson RA, Clayton T, et al. Quality of life after
coronary angioplasty or continued medical treatment for angina:
three-year follow up in the RITA-2 trial, Randomized Intervention
Treatment of Angina. J Am Call Cardiol. 2000;35:907-914.

17. Hofman-Bang C, Lisspers J, Nordlander R, et al. Two-year results
of a controlled study of residential rehabilitation for patients
treated with percutaneous transluminal coronary angiography:
randomized study of a multifactorial programme. Eur Heart J.
1999;20: 1465-1474.

18. Moser DJ, Cohen RA, Clark MM et al. Neuropsychological functioning
among cardiac rehabilitation patients. J Cardiopulm
Rehabil. 1999; 19:91-97.

19. Lisspers J, Sundin O, Hofman-Bang C, el al. Behavioral effects
of a comprehensive multifaceted program for lifestyle change
after percutaneous transluminal coronary angioplasty: a prospective,
randomized, controlled study. J Psychosom Res. 1999;46:
143-154.


* Selection of articles for review: After examining the titles of these articles, we determined that 7 research articles (Paquet et al, Reddy et al, Eisenberg et al, Raine et al, Pilote et al, Bengtsson et al, Pocock et al) and 1 review paper (Stewart et al) did not focus on the effect of cardiac rehabilitation on QOL for patients after PTCA, and we excluded them from further discussion. Another 6 articles addressed issues that were not relevant to our patient's concern, such as physical functioning (Pasquali et al), neuropsychological neu·ro·psy·chol·o·gy  
n.
The branch of psychology that deals with the relationship between the nervous system, especially the brain, and cerebral or mental functions such as language, memory, and perception.
 functioning (Moser et al), factors influencing health-related QOL in cardiac rehabilitation (Jamieson et al and Gardner et al), comparison of different QOL evaluation tools (Muller-Nordhorn et al), and self-efficacy (Evon et al) and were excluded from further review. Although one article with a randomized controlled trial A randomized controlled trial (RCT) is a scientific procedure most commonly used in testing medicines or medical procedures. RCTs are considered the most reliable form of scientific evidence because it eliminates all forms of spurious causality.  (RCT RCT Randomized Controlled Trial
RCT Regimental Combat Team (infantry regiment with their own artillery, engineers, medical and tanks)
RCT Rollercoaster Tycoon
RCT Randomized Clinical Trial
RCT Rhondda Cynon Taff
) design (Hevey et al) addressed our topic, we excluded it from further examination because the participants in that study either had an MI or underwent coronary artery bypass grafting coronary artery bypass graft
n. Abbr. CABG
A surgical procedure in which a section of vein or other conduit is grafted between the aorta and a coronary artery below the region of an obstruction in that artery.
 and were different from our patient.

In addition, we found that 2 articles (Lisspers et al and Hofman-Bang et al) were based on the same group of subjects but reported the outcomes in different follow-up periods. The article by Hofman-Bang et al, however, placed more emphasis on the long-term maintenance of achieved behavior and risk factor-related changes rather than the time frame that concerned our patient and we excluded it from further review. We, therefore, deemed the remaining 3 articles (Yu et al, Belardinelli et al, Lisspers et al) to be the best evidence because they used an RCT design and the content pertained to our patient's concern. These articles are discussed below, and the relevance of each article to our clinical question is addressed.

Yu CM, Lau CP, Chau J, et al. A short course of cardiac rehabilitation program is highly cost effective in improving long-term quality of life in patients with recent myocardial infarction or percutaneous coronary intervention Percutaneous coronary intervention (PCI), commonly known as coronary angioplasty or simply angioplasty, is a therapeutic procedure to treat the stenotic (narrowed) coronary arteries of the heart found in coronary heart disease. . Arch Phys Med Rehabil. 2004;85:1915-1922.

This article described a prospective RCT. The researchers evaluated the long-term effect of a cardiac rehabilitation and prevention program (CRPP CRPP Centre de Recherches en Physique des Plasmas (French: Center of Plasma Physics Research; Switzerland)
CRPP Committee Representing the People's Parliament (Burma) 
) on QOL and its cost-effectiveness in a total of 269 patients (76% were men; mean age [[+ or -]SD]=64[+ or -]11 years) with a recent MI (n=193) or after an elective percutaneous coronary intervention (n=76). All the subjects were randomized ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
 in a ratio of 2 to 1 into either the CRPP group (which received an 8-week exercise and education class in phase II) or the control group (which received "conventional" therapy without an exercise program). They were followed until all 4 phases of the program were completed (about 2 years). The main outcomes were assessed using the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) and Symptoms Questionnaire.

The results showed that, in the CRPP group, 6 of the 8 SF-36 dimensions improved significantly by phase II and were maintained throughout the study period. In terms of their psychology, patients in the CRPP group were less anxious and depressed and felt more relaxed and contented after training. In addition to the conventionally known effect of exercise training on physical capacity for subjects receiving PTCA, this study showed significant benefits of exercise training on mental health, social functioning social functioning,
n the ability of the individual to interact in the normal or usual way in society; can be used as a measure of quality of care.
, emotional role, and vitality. These were all major outcomes that our patient lacked.

The authors concluded that a short-course CRPP was highly cost-effective in providing better QOL to patients with a recent MI or after an elective percutaneous coronary intervention. In addition, the improvement in QOL took effect quickly and was sustained for at least 2 years after CRPP.

A primary strength of this study was that it used an RCT design; furthermore, most of the major outcomes were comparable at baseline between the 2 groups, and the study provided both point measures and measures of variability with statistical analysis. Most articles address the effects of exercise training on cardiopulmonary capacity; this paper investigated the effect of cardiac rehabilitation on QOL, especially the mental health and psychosocial functioning aspects that are affecting our middle-aged patient.

From our perspective, a primary weakness of the study was the lack of blinding, and this potential bias might affect the outcomes of exercise training shown in this study. Another potential weakness was the relatively low follow-up rate (75.8%), which is below the suggested level of many literature appraisal tools (such as the PEDro Scale). (2) The Table lists our critical appraisal Noun 1. critical appraisal - an appraisal based on careful analytical evaluation
critical analysis

appraisal, assessment - the classification of someone or something with respect to its worth
 of the Yu et al article, as well as the other articles retrieved by our literature search, using the PEDro Scale.

Although there were some weaknesses in the study, the characteristics of the subjects recruited in this study were similar to our patient and the exercise protocol was similar to the one he was receiving. We concluded that this study provided moderate evidence that would help us make a clinical decision about whether exercise training could increase the QOL in our patient.

Belardinelli R, Paolini I, Cianci G, et al. Exercise training intervention after coronary angioplasty: the ETICA trial. J Am Coil Cardiol. 2001;37:1891-1900.

This RCT seemed highly relevant to our clinical question because the subjects had a mean age ([+ or -]SD) of 57[+ or -]10 years, and most of the subjects were male and had characteristics comparable to our patient. In this study, patients exercised 3 times a week for 6 months, at an intensity of 60% of peak oxygen uptake; and this protocol was similar to ours. They originally recruited 130 patients with CAD who underwent PTCA with or without a stent to determine the effects of exercise training on functional capacity, QOL, the restenosis rate, and the readmission rate. Subjects were randomized into 2 matched groups after baseline examination baseline examination Clinical practice A physical exam which is part of an initial Pt-physician contact, and designed to assess a Pt's eligibility for enrollment in a clinical trial and produce requisite baseline data. . The examination--which was carried out at baseline, 6 months after the cardiac rehabilitation program, and at the 12-month follow-up--included: a symptom-limited cardiopulmonary exercise Noun 1. cardiopulmonary exercise - exercise intended to strengthen the circulatory system
jump rope - a child's game or a cardiopulmonary exercise in which the player jumps over a swinging rope
 test for measuring hemodynamic he·mo·dy·nam·ics  
n. (used with a sing. verb)
The study of the forces involved in the circulation of blood.



he
 and metabolic variables, echocardiography Echocardiography Definition

Echocardiography is a diagnostic test that uses ultrasound waves to create an image of the heart muscle. Ultrasound waves that rebound or echo off the heart can show the size, shape, and movement of the heart's valves and
 for left ventricular volume and diameter measures, thallium scintigraphy scintigraphy /scin·tig·ra·phy/ (sin-tig´rah-fe) the production of two-dimensional images of the distribution of radioactivity in tissues after the internal administration of a radiopharmaceutical imaging agent, the images being obtained  for myocardial myocardial /myo·car·di·al/ (-kahr´de-al) pertaining to the muscular tissue of the heart.

myocardial

pertaining to the muscular tissue of the heart (the myocardium).
 perfusion, and coronary angiography coronary angiography Interventional cardiology A diagnostic technique in which a radiocontrast is injected directly into the coronary arteries, allowing visualization and quantification of stenosis and/or obstruction.  for restenosis and progression of CAD. Quality of life was assessed using 2 questionnaires: the Duke Activity Status Index Duke Activity Status Index Cardiology A measure of a person's functional capacity based on a 12-item questionnaire that correlates with peak O2 uptake during exercise testing  and the SF-36, with a higher score indicating better QOL.

Compared with the patients in the control group, patients in the training group experienced significant improvements in peak oxygen uptake (26%, P<.001), QOL (26.8%, P=.001), lower residual stenosis stenosis /ste·no·sis/ (ste-no´sis) pl. steno´ses   [Gr.] stricture; an abnormal narrowing or contraction of a duct or canal.  diameter (-29.7%, P=.045), fewer new lesions in coronary arteries (7.6% vs 25%, P=.038), a lower event rate (11.9% vs 32.2%, risk ratio=0.71, P=.008), and a lower rate of rehospitalization (18.6% vs 46%, risk ratio=0.69, P<.001). The authors suggested that exercise training of moderate intensity was safe and could improve functional capacity and QOL, especially in health perception and the mental health domain after PTCA or stent, despite an unchanged restenosis rate.

The critical appraisal of this article showed the presence of 9 out of 11 items in the PEDro Scale (Table), (2) with the exceptions being the concealment of randomization randomization (ranˈ·d·m  and blinding of patients. These weak points, however, are common among this type of study. The evidence provided by the article seemed fairly strong because of its RCT design and its large sample size. Another potential strength was that some of the outcomes were analyzed by "intention to treat," which provided information on those subjects who withdrew during the training period. In addition, this study provided both point measures and measures of variability of most key outcomes and reported between-group comparisons using an appropriate statistical method. According to the results, the follow-up rate of this study was about 80%, somewhat below the recommended 85%, but we believed that this was still an acceptable level.

From our perspective, this was a highly valid study that provided strong evidence that exercise training was beneficial for patients after PTCA, not only in exercise capacity and physiological improvement, but also for mental and psychosocial health.

Lisspers J, Sundin O, Harmon-Bang C, et al. Behavioral effects of a comprehensive, multifactorial multifactorial /mul·ti·fac·to·ri·al/ (mul?te-fak-tor´e-al)
1. of or pertaining to, or arising through the action of many factors.

2.
 program for lifestyle change after percutaneous transluminal coronary angioplasty: a prospective, randomized, controlled study. J Psychosom Res. 1999;46:143-154.

The participants recruited in this study were similar to our patient. The authors stated that they were especially interested in using a behavioral intervention behavioral intervention Behavior modification, behavior 'mod', behavioral therapy, behaviorism Psychiatry The use of operant conditioning models, ie positive and negative reinforcement, to modify undesired behaviors–eg, anxiety.  with patients treated with PTCA because these patients had low morbidity and mortality Morbidity and Mortality can refer to:
  • Morbidity & Mortality, a term used in medicine
  • Morbidity and Mortality Weekly Report, a medical publication
See also
  • Morbidity, a medical term
  • Mortality, a medical term
 and a higher percentage of these patients returned to work than those who had an acute MI and underwent coronary artery bypass grafting. Therefore, the authors believed that patients treated with PTCA would achieve long-term preventive effects from changes in lifestyle.

This prospective RCT recruited 93 patients with coronary conditions who received the PTCA (mean age=53 years) and randomly assigned them into either an intervention or a control group. Subjects in the intervention group participated in a 4-week comprehensive, behaviorally oriented program focused on stress management, diet, exercise, and smoking cessation smoking cessation Public health Temporary or permanent halting of habitual cigarette smoking; withdrawal therapies–eg, hypnosis, psychotherapy, group counseling, exposing smokers to Pts with terminal lung CA and nicotine chewing gum are often ineffective. , as well as practical skills training in physical exercise, food preparation, biofeedback biofeedback, method for learning to increase one's ability to control biological responses, such as blood pressure, muscle tension, and heart rate. Sophisticated instruments are often used to measure physiological responses and make them apparent to the patient, who , and applied relaxation. These participants were not given a well-constructed exercise training program, however. The authors carried out assessments of lifestyle behaviors using a self-developed questionnaire, psychological factors using the Heart and Lifestyle Type A Measure (HALTAM) questionnaire, and exercise capacity using symptom-limited maximal exercise tests at baseline and after 12 months. They also gathered data on endpoints such as numbers of clinical events, readmissions, or days in hospital.

The results showed that the patients in the intervention group improved significantly in measures of smoking cessation, exercise, and dietary habits. These self-rated changes were confirmed by weight reductions and improved exercise capacity as well as by between-group differences in subclinical subclinical /sub·clin·i·cal/ (sub-klin´i-k'l) without clinical manifestations.

sub·clin·i·cal
adj.
Not manifesting characteristic clinical symptoms. Used of a disease or condition.
 chest pain during an exercise test. Few effects, however, were found on the different psychological variables, as well as on morbidity or return-to-work rate.

A primary strength of this study lies in its RCT design and high follow-up rate of more than 90%. Another potential strength was that the 2 groups were comparable at baseline regarding the most important prognostic indicators. The study also provided point measures and measures of variability for the major outcomes. However, the potential weakness of the study was the fact that the authors did not give a clear account of whether the subjects, the therapist who administered the therapy, and the evaluators who measured outcomes were blinded to the group assignment. In addition, none of the major outcomes were analyzed by "intention to treat"; therefore, we could not know the characteristics of the subjects who dropped out. This RCT with high follow-up rate showed no significant effect of a 4-week "individual" behavior-oriented program on stress, and only a few psychological variables were shown to be different between the groups.

From our perspective, this study provided moderate evidence because of its uncertain blinding procedure and lack of "intention to treat" analysis. Moreover, this study investigated the effect of a behavior-oriented program that did not include a conventional cardiac rehabilitation component such as aerobic exercise aerobic exercise,
n sustained repetitive physical activity, such as walking, dancing, cycling, and swimming, that elevates the heart rate and increases oxygen consumption resulting in improved functioning of cardio-vascular and respiratory systems.
 training. This intervention was different from our protocol; therefore, the results might not be applicable to our patient.

* Extended search: Because anxiety was our patient's most serious health concern after the episode of chest tightness, we decided to repeat the search using the same database (MED-LINE), but using a somewhat broader term for the intervention. We selected "well-being" to make sure that we did not miss any articles that used QOL as an outcome measure for patients who underwent PTCA, and we also searched directly by the keyword "anxiety." We also used the abbreviations "PTCA" and "CAD" rather than spelling them out. We decided to restrict our other keywords to the primary problem. Our searches used the following search strings: (1) cardiac rehabilitation AND PTCA AND well-being and (2) cardiac rehabilitation AND CAD AND anxiety. After setting the same limits as our original search, these searches retrieved 3 and 7 articles, respectively (Figs. 2 and 3). We reviewed the tides of each citation, and excluded 3 studies (Lichtenberger et al, Michalsen et al, Sheps et al) from further discussion because they did not include the cardiac rehabilitation intervention. Another 5 articles addressed issues that were not relevant to our patient (Hevey et al, Marcuccio et al, Seki et al) or were not his primary concern, such as heart rate variability Heart rate variability (HRV) is a measure of variations in the heart rate. It is usually calculated by analysing the time series of beat-to-beat intervals from ECG or arterial pressure tracings.  (Lavoie et al) or the impact of aging on hostility (Lavie and Miliani, Am J Geriatr Cardiol, 2004). However, 2 citations (Higgins et al and Lavie and Milani, Am J Geriatr Cardiol, 2004) did suggest that cardiac rehabilitation could improve well-being and reduce the prevalence of anxiety. These articles are discussed below.
Figure 2. Citations retrieved by search using the keywords "cardiac
rehabilitation" and "PTCA" and "well-being."

1. Lichtenberger CM, Martin Ginis KA, MacKenzie CL, McCartney N.
Body image and depressive symptoms as correlates of self-reported
versus clinician-reported physiologic function. J Cardiopulm
Rehabil. 2003;23:53-59.

2. Hevey D, Brown A, Cahill A, et al. Four-week multidisciplinary
cardiac rehabilitation produces similar improvements in exercise
capacity and quality of life to a 10-week program. J Cardiopulm
Rehabil. 2003;23:17-21.

3. Higgins HC, Hayes RL, McKenna KT. Rehabilitation outcomes
following percutaneous coronary interventions (PCI). Patient Educ
Couns. 2001;43:219-230.

Figure 3. Citations retrieved by search using the keywords "cardiac
rehabilitation" and "CAD" and "anxiety."

1. Michalsen A, Grossman P, Lehmann N, et al. Psychological and
quality-of-life outcomes from a comprehensive stress reduction
and lifestyle program in patients with coronary artery
disease: results of a randomized trial. Psychother Psychosom.
2005;74:344-352.

2. Lavoie KL, Fleet RP, Laurin C, et al. Heart rate variability in
coronary artery disease patients with and without panic disorder.
Psychiatry Res. 2004;128:289-299.

3. Lavie CV, Milani RV. Impact of aging on hostility in coronary
patients and effects of cardiac rehabilitation and exercise training
in elderly persons. Am J Geriatr Cardiol. 2004; 13:125-130.

4. Lavie C J, Milani RV. Prevalence of anxiety in coronary patients
with improvement following cardiac rehabilitation and exercise
training. Am J Cardiol. 2004;93:336-339.

5. Marcuccio E, Loving N, Bennett SK, Hayes SN. A survey of
attitudes and experiences of women with heart disease.
Women's Health Issues. 2003; 13:23-31.

6. Seki E, Watanabe Y, Sunayama S, et al. Effects of phase III
cardiac rehabilitation programs on health-related quality of life
in elderly patients with coronary artery disease: Juntendo Cardiac
Rehabilitation Program (J-CARP). Circ J. 2003;67:73-77.

7. Sheps DS, Kaufmann PG, et al. Sex differences in chest pain
in patients with documented coronary artery disease and exercise-induced
ischemia: Results from the PIMI study. Am Heart J.
2001;142:864-871.


Higgins HC, Hayes RL, McKenna KT. Rehabilitation outcomes following percutaneous coronary intervention (PCI (1) (Payment Card Industry) See PCI DSS.

(2) (Peripheral Component Interconnect) The most widely used I/O bus (peripheral bus).
). Patient Educ Couns. 2001;43:21-30.

Patients who have undergone PTCA have been reported to have higher levels of uncertainty and psychological distress psychological distress The end result of factors–eg, psychogenic pain, internal conflicts, and external stress that prevent a person from self-actualization and connecting with 'significant others'. See Humanistic psychology.  3 months after the procedure than patients who have had coronary artery bypass grafting. Patients receiving PTCA, however, do not routinely participate in cardiac rehabilitation because PTCA involves a shorter hospital stay and because some clinicians believe that the psychological well-being psychological well-being Research A nebulous legislative term intended to ensure that certain categories of lab animals, especially primates, don't 'go nuts' as a result of experimental design or conditions  and physical status of patients receiving PTCA improve spontaneously.

This prospective study evaluated the effect of an individualized in·di·vid·u·al·ize  
tr.v. in·di·vid·u·al·ized, in·di·vid·u·al·iz·ing, in·di·vid·u·al·iz·es
1. To give individuality to.

2. To consider or treat individually; particularize.

3.
, comprehensive, home-based cardiac rehabilitation program in 99 patients who received percutaneous coronary interventions (PCI). The participants were randomized to a control group (n=49, which received "standard care" plus telephone follow-up) or intervention (n=50) groups. The intervention consisted of an "individualized" moderate-intensity walking program with a graded increase in the frequency and duration of exercise, risk factor modification, and psychosocial counseling on risk factors, psychological well-being, functional capacity, and work resumption.

Psychological well-being was measured using the Psychological Adjustment to Illness Scale, self-report version, and functional capacity was determined by the Canadian Cardiovascular Society functional classification Canadian Cardiovascular Society functional classification Cardiology A system used to stratify the severity of angina pectoris. See APSAC. Cf New York Heart Association classification
 for angina and the Specific Activity Questionnaire. Data were collected at hospital admission, 2 months after PCI, and 12 months after PCI.

The results suggested that the intervention group had more advantageous outcomes, including the improvement in serum cholesterol levels, body mass index, psychological well-being, and functional capacity. More patients in the intervention group returned to work and did so more quickly. These findings suggested that an individualized, comprehensive, home-based cardiac rehabilitation program could improve risk factor profiles and work resumption patterns for patients following PCI.

The strength of this study was its RCT design, and both groups were similar at baseline regarding the most important prognostic indicators. The study also provided both point measures and measures of variability for major outcomes and reported between-group comparisons for most key outcomes. However, a potential weakness of the study was the blinding issue. Another potential weakness was that the follow-up rate was about 75.8%, mildly low according to the developers of the PEDro Scale. In addition, none of the main outcomes was analyzed by "intention to treat," which would mask the possible adverse effect of the exercise training on the patients.

In fact, this study did not use a phase II cardiac rehabilitation program, which includes well-constructed aerobic exercise training; instead, it focused on education and counseling. We did not know whether the dosage of the "moderate intensity walking" was sufficient to provide the same effects for our patient. Although this study provided moderate evidence that home-based exercise was beneficial for well-being, rate of work resumption, and functional capacity for patients with CAD who received PTCA, we believed that it was not as relevant to our patient because the intervention protocol did not apply to his case.

Lavie CJ, Milani RV. Prevalence of anxiety in coronary patients with improvement following cardiac rehabilitation and exercise training. Am J Cardiol. 2004;93:336-339.

This nonrandomized clinical trial provided information on the effects of cardiac rehabilitation phase II programs in patients with CAD and compared the effect between the subjects with high levels of anxiety and subjects without anxiety, the issue about which our patient was largely concerned. This study recruited 500 participants after CAD events (eg, acute MI, coronary artery bypass grafting, and PTCA) to attend a 12-week comprehensive cardiac rehabilitation program (CCRP CCRP College Curriculum Renewal Project
CCRP Command and Control Research Program
CCRP Common Controls Replacement Project
CCRP Certified Clinical Research Professional
CCRP Certified Canine Rehabilitation Practitioner
CCRP C4ISR Cooperative Research Program
). The CCRP included 36 conventional aerobic exercise training sessions at an intensity close to anaerobic threshold anaerobic threshold (anˈ·  and 36 educational sessions regarding all aspects of CAD risks, including psychological stress. The anxiety symptoms were assessed by the Kellner Symptom Questionnaire, which has been validated for psychological distress, including depression, hostility, somatization somatization /so·ma·ti·za·tion/ (so?mah-ti-za´shun) the conversion of mental experiences or states into bodily symptoms.

so·ma·ti·za·tion
n.
, and anxiety; a lower score indicated a more favorable behavioral trait. The authors determined that subjects with anxiety had a Kellner symptom score of more than 7, and subjects with high anxiety had a score above 10. Quality of life was assessed by using the SF-36, with a higher score indicating a better QOL.

At baseline, 133 subjects had anxiety and 367 subjects did not have anxiety. Within the anxiety group, 66 subjects were defined as having high anxiety. After the CCRP, there were significant reductions in the prevalence of anxiety (-56%) and high anxiety (-69%) among the subjects. The subjects with high anxiety had statistically greater improvements in anxiety scores (-56% and -14%), depression scores (-56% and -17%), and overall QOL scores (+28% and +14%) compared with subjects without anxiety. This study demonstrated significant benefits after CCRP, including improvements in the overall CAD risk profile as well as marked reductions in anxiety.

From our perspective, a potential drawback of the study was the fact that it was not an RCT design nor were subjects or researchers blinded, and these potential biases might influence the results shown in this study. Another potential weakness was that data on the follow-up rate of the subjects were not provided, and we did not know whether the characteristics of all participants were reported (intention-to-treat analysis). However, the major outcome of this article focused on anxiety, which was more relevant to our patient's concern, and, therefore, might provide direct and useful information. Therefore, though this study had many weaknesses, it still provided weak to moderate evidence that home-based exercise was beneficial for anxiety reduction and QOL improvement for patients with CAD.

* Clinical decision: We told the patient that we found several relevant articles through our search that directly related the cardiac rehabilitation to QOL, mental health, and psychosocial functioning in patients with coronary conditions following PTCA or stent procedures. According to our review of the quality (Table) and the results of 5 studies, one study provided strong evidence for a beneficial effect of cardiac rehabilitation on QOL, whereas 3 provided only moderately strong evidence for a beneficial effect of cardiac rehabilitation, and one provided moderate support for no effect of cardiac rehabilitation on QOL for a patient such as ours. Among these articles, the result of Belardinelli et al was most applicable because of the intervention provided and the outcome measures used and because the characteristics of the subjects recruited to the study were similar to our case.

According to the results of Lisspers et al, a cardiac rehabilitation program did not provide significant positive improvement in QOL, possibly because of insufficient program duration. The program durations of the other 4 studies were between 8 weeks and 6 months. Sufficient duration might be the key factor in determining the effect of cardiac rehabilitation on QOL. In addition, there was no routine exercise training in the intervention provided by Lisspers et al. Previous studies reported that exercise training at proper intensity could (1) normalize normalize

to convert a set of data by, for example, converting them to logarithms or reciprocals so that their previous non-normal distribution is converted to a normal one.
 endothelial endothelial /en·do·the·li·al/ (-the´le-al) pertaining to or made up of endothelium.
Endothelial
A layer of cells that lines the inside of certain body cavities, for example, blood vessels.
 fimction by recruiting collateral coronary arteries or increasing nitric oxide nitric oxide or nitrogen monoxide, a colorless gas formed by the combustion of nitrogen and oxygen as given by the reaction: energy + N2 + O2 → 2NO; m.p. −163.6°C;; b.p. −151.8°C;. , (3) (2) improve myocardial perfusion, (4) and (3) prevent the progression of left ventricular diastolic Diastolic
The phase of blood circulation in which the heart's pumping chambers (ventricles) are being filled with blood. During this phase, the ventricles are at their most relaxed, and the pressure against the walls of the arteries is at its lowest.
 function. (5) These results indicated that regular exercise in patients with CAD improved the physiological function of coronary arteries and might be the mechanism responsible for the perception that regular exercise induced cardiovascular "well-being" and, therefore, contribute to QOL improvement.

In addition to exercise training, patients might benefit from cardiac rehabilitation in attenuating neoinidmal growth after PTCA with stent insertion and in preventing the further progression of CAD. (6) The reasons for the improvement in QOL by comprehensive cardiac rehabilitation program are multifactorial. Quality of life consists of distinct health domains, mainly physical function, social functioning, and general mental health. The improvement in psychological distress as well as somatic somatic /so·mat·ic/ (so-mat´ik)
1. pertaining to or characteristic of the soma or body.

2. pertaining to the body wall in contrast to the viscera.


so·mat·ic
adj.
 symptoms will improve the perceived QOL. As Yu et al stated, both the gain in physical functioning and the psychological support provided by physical therapists and whole the cardiac rehabilitation team members were likely contributing factors.

According to the results of Belardinelli et al, in addition to the anatomical or functional adaptations of coronary arteries produced by exercise training, the occurrence of new coronary artery stenosis in the patients who received training was reduced in part by an improved coronary risk factor profile induced by physical conditioning. From the results of Higgins et al, the participants in the cardiac rehabilitation intervention returned to work more quickly and showed significant improvement in work status compared with the control group provided the evidence that cardiac rehabilitation improved the social and psychological domains of QOL.

In addition, anxiety, our patient's principal problem, may result in increased sympathetic stimulation or impaired vagal vagal /va·gal/ (va´gal) pertaining to the vagus nerve.

va·gal
adj.
Of or relating to the vagus nerve.



vagal

pertaining to the vagus nerve.
 tone and may be involved with increased cardiac mortality. The results of Lavie and Milani showed cardiac rehabilitation and exercise training was effective in reducing the anxiety score, and, therefore, contributing to the improvement in QOL. Based on the evidence from the retrieved relevant studies, the answer to our clinical question--whether cardiac rehabilitation has an effect on the improvement of QOL and well-being--was clear.

After talking with us, our patient appeared to understand that there was evidence of beneficial outcomes---such as improved functional capacity and QOL and lower hospital readmission rate--with cardiac rehabilitation, and he was willing to continue the program on a regular basis and to maintain an active lifestyle as we recommended. (7-9)

This article was submitted November 29, 2005, and was accepted September 11, 2006.

[DOI (Digital Object Identifier) A method of applying a persistent name to documents, publications and other resources on the Internet rather than using a URL, which can change over time. : 10.2522/ptj.20050375]

References

(1) American College of Sports Medicine. ACSM's Guidelines for Exercise Testing and Prescription. 7th ed. Philadelphia, Pa: Williams & Wilkins; 2005.

(2) PEDro Scale page, Physiotherapy Evidence Database Web site. Available at: http://www.pedro.fhs.usyd.edu.au/scale_item.html. Accessed September 13, 2006.

(3) Hambrecht R, Wolf A, Gielen S, et al. Effect of exercise on coronary endothelial function in patients with coronary heart disease coronary heart disease: see coronary artery disease.
coronary heart disease
 or ischemic heart disease

Progressive reduction of blood supply to the heart muscle due to narrowing or blocking of a coronary artery (see atherosclerosis).
. N Eng J Med. 2000;342:454-460.

(4) Kendziorra K, Walther C, Foerster M, et al. Changes in myocardial perfusion due to physical exercise in patients with stable coronary artery disease. Eur J Nucl Med Mol Imaging. 2005;32:813-819.

(5) Yu CM, Li LS, Lam MF, et al. Effect of a cardiac rehabilitation program on left ventricular diastolic function and its relationship to exercise capacity in patients with coronary heart disease: experience from a randomized, controlled study. Am Heart J. 2004;147:11-18.

(6) Hosokawa S, Hiasa Y, Takahashi T, Itoh S. Effect of regular exercise on coronary endothelial function in patients with recent myocardial infarction. Circ J. 2003;67:221-224.

(7) Lisspers J, Sundin O, Ohman A, et al. Long-term effects of lifestyle behavior change Behavior change refers to any transformation or modification of human behavior. Such changes can occur intentionally, through behavior modification, without intention, or change rapidly in situations of mental illness.  in coronary artery disease: effects on recurrent coronary events after percutaneous coronary intervention. Health Psychol. 2005;24:41-48.

(8) Warburton DE, McKenzie DC, Haykowsky MJ, et al. Effectiveness of high-intensity interval training High-intensity interval training (HIIT) is an exercise strategy that is intended to improve performance with short training sessions.

A HIIT session involves a warmup period, several short, maximum-intensity efforts separated by moderate recovery intervals, and a
 for the rehabilitation of patients with coronary artery disease. Am J Cardiol. 2005;95:1080-1084.

(9) Hambrecht R, Walther C, Mobius-Winkler S, et al. Percutaneous coronary angioplasty compared with exercise training in patients with stable coronary artery disease: a randomized trial. Circulation. 2004;109: 1371-1378.

* Boehringer Ingelheim Pharmaceuticals Inc, a subsidiary of Boehringer Ingelheim Carp, 900 Ridgebury Rd, PO Box 368, Ridgefield, CT 06877-0368.

([dagger]) Ovid Technologies Ovid Technologies (or just Ovid) is part of the Wolters Kluwer group of companies. It provides access to online bibliographic databases, journals and other products, chiefly in the area of health sciences. , 333 Seventh Ave, 20th Floor, New York New York, state, United States
New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of
, NY 10001.

Meng-Yueh Chien, PT, MS, is Lecturer at the School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University National Taiwan University (Traditional Chinese: 國立臺灣大學; Simplified Chinese: 国立台湾大学 , Taipei, Taiwan.

Mei-Wun Tsai, PT, PhD, is Lecturer at the Institute and Faculty of Physical Therapy, National Yang-Ming University, Taipei, Taiwan.

Ying Tai Wu, PT, PhD, is Director and Associate Professor of the School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University.

Ms Chien and Dr Tsai provided concept/idea/research design. Ms Chien and Dr Wu provided writing and data collection and analysis. Dr Tsai and Dr Wu provided consultation (including review of manuscript before submitting).
Table. PEDro Scale (2) Evaluation

Items                       Yu   Belardinelli  Lisspers  Higgins  Lavie

1. Eligiblity criteria      Yes  Yes           Yes       Yes      Yes

2. Random allocation        Yes  Yes           Yes       Yes      No

3. Concealed allocation     No   No            No        No       Yes

4. Baseline comparability   Yes  Yes           Yes       Yes      No

5. Blinded participant      No   No            No        No       Yes

6. Blinded therapist and    Yes  Yes           Yes       Yes      Yes
treatment administrator

7. Blinded assessor         Yes  Yes           Yes       Yes      Yes

8. Adequacy of              No   Yes           Yes       Yes      No
follow up (>85%)

9. Intention-to-treat       Yes  Yes           No        No       No
analysis

10. Between-group           Yes  Yes           Yes       Yes      Yes
comparison

11. Point estimate and      Yes  Yes           Yes       Yes      Yes
measure of variability

Score                       8    9             8         8        7
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Title Annotation:Evidence in practice
Author:Wu, Ying-Tai
Publication:Physical Therapy
Date:Dec 1, 2006
Words:6485
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