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Evidence in Practice |
Meng-Yueh Chien, PT, MS, Lecturer at the School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University, Taipei, Taiwan
Mei-Wun Tsai, PT, PhD, is Lecturer at the Institute and Faculty of Physical Therapy, National YangMing University, Taipei, Taiwan
Ying-Tai Wu, PT, PhD, Director and Associate Professor of the School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
Submitted November 29, 2005;
Accepted September 11, 2006
| 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.
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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 phosphokinase and creatinine phosphokinase-MB band levels were elevated significantly, and an elevated plasma troponin I level (14.1 IU) also was noted.
The electrocardiogram (ECG) confirmed the evolution of an extensive anteroseptal myocardial infarction (MI). He then was transferred to the intensive care unit where 100 mg of tissue plasminogen activator 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, and congestive heart failure was suspected. After medical treatment in the intensive care unit, the patient rarely experienced any chest pain and had a normal sinus rhythm.
Three days later, cardiac catheterization was performed, which revealed a 90% occlusion of the left anterior descending artery at the second diagonal, a 50% occlusion of the mid-right coronary artery, a 50% occlusion of a diagonal artery of the circumflex artery, and left ventricular dysfunction (left ventricular ejection fraction of 40%). His New York Heart Association classification was functional class I. A percutaneous transluminal coronary angioplasty (PTCA) 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 (diltiazem, 60 mg 3 times a day), antiplatelet agents (aspirin, 100 mg every day), and nitrates (sublingual nitroglycerin as required). His cardiologist did not prescribe a beta-blocker because of concern about his past history of bronchial asthma. 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 phase II program in our outpatient physical therapy department after a symptom-limited maximal exercise test. The exercise test using a cycle ergometer 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 and leg fatigue without angina or ST-segment changes.
 | Examination and evaluation: |
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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 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 guidelines.1
The patient also received education regarding atherosclerotic heart disease, risk factors, and exercise precautions. During the initial training session, the patient’s diastolic blood pressure 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 that caused him to worry about his health. He went to his cardiologist, who told him that the thallium 201 imaging showed no evidence of restenosis of the coronary arteries and that the chest tightness might due to occasional vasospasm. His cardiologist prescribed dipyridamole (Persantine,* 75 mg 3 times a day) for dilation 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) was affected by these concerns, which included the possible recurrence of chest tightness, possible restenosis, and possible hospital readmission. 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: |
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 TopExamination and evaluation: Databases used for search: Initial Keywords: cardiac...Selection of articles for...Yu CM, Lau CP,...Belardinelli R, Paolini I,...Lisspers J, Sundin O,...Extended search:Higgins HC, Hayes RL,...Lavie CJ, Milani RV....Clinical decision:References |
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(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 |
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TopExamination and evaluation:Databases used for search:Initial Keywords: cardiac...Selection of articles for...Yu CM, Lau CP,...Belardinelli R, Paolini I,...Lisspers J, Sundin O,...Extended search:Higgins HC, Hayes RL,...Lavie CJ, Milani RV....Clinical decision:References |
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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.
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| Selection of articles for review: |
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TopExamination and evaluation:Databases used for search:Initial Keywords: cardiac...Selection of articles for...Yu CM, Lau CP,...Belardinelli R, Paolini I,...Lisspers J, Sundin O,...Extended search:Higgins HC, Hayes RL,...Lavie CJ, Milani RV....Clinical decision:References |
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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. Arch Phys Med Rehabil. 2004;85:1915–1922. |
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TopExamination and evaluation:Databases used for search:Initial Keywords: cardiac...Selection of articles for...Yu CM, Lau CP,...Belardinelli R, Paolini I,...Lisspers J, Sundin O,...Extended search:Higgins HC, Hayes RL,...Lavie CJ, Milani RV....Clinical decision:References |
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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, 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 of the Yu et al article, as well as the other articles retrieved by our literature search, using the PEDro Scale.
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| Belardinelli R, Paolini I, Cianci G, et al. Exercise training intervention after coronary angioplasty: the ETICA trial. J Am Coll Cardiol. 2001;37:1891–1900. |
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TopExamination and evaluation:Databases used for search:Initial Keywords: cardiac...Selection of articles for...Yu CM, Lau CP,...Belardinelli R, Paolini I,...Lisspers J, Sundin O,...Extended search:Higgins HC, Hayes RL,...Lavie CJ, Milani RV....Clinical decision:References |
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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 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 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, Hofman-Bang C, et al. Behavioral effects of a comprehensive, multifactorial program for lifestyle change after percutaneous transluminal coronary angioplasty: a prospective, randomized, controlled study. J Psychosom Res. 1999;46:143–154. |
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TopExamination and evaluation:Databases used for search:Initial Keywords: cardiac...Selection of articles for...Yu CM, Lau CP,...Belardinelli R, Paolini I,...Lisspers J, Sundin O,...Extended search:Higgins HC, Hayes RL,...Lavie CJ, Milani RV....Clinical decision:References |
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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, as well as practical skills training in physical exercise, food preparation, biofeedback, 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 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 training. This intervention was different from our protocol; therefore, the results might not be applicable to our patient.
| Extended search: |
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TopExamination and evaluation:Databases used for search:Initial Keywords: cardiac...Selection of articles for...Yu CM, Lau CP,...Belardinelli R, Paolini I,...Lisspers J, Sundin O,...Extended search:Higgins HC, Hayes RL,...Lavie CJ, Milani RV....Clinical decision:References |
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| Higgins HC, Hayes RL, McKenna KT. Rehabilitation outcomes following percutaneous coronary intervention (PCI). Patient Educ Couns. 2001;43:21–30. |
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TopExamination and evaluation:Databases used for search:Initial Keywords: cardiac...Selection of articles for...Yu CM, Lau CP,...Belardinelli R, Paolini I,...Lisspers J, Sundin O,...Extended search:Higgins HC, Hayes RL,...Lavie CJ, Milani RV....Clinical decision:References |
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This prospective study evaluated the effect of an individualized, 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 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. |
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TopExamination and evaluation:Databases used for search:Initial Keywords: cardiac...Selection of articles for...Yu CM, Lau CP,...Belardinelli R, Paolini I,...Lisspers J, Sundin O,...Extended search:Higgins HC, Hayes RL,...Lavie CJ, Milani RV....Clinical decision:References |
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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: |
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TopExamination and evaluation:Databases used for search:Initial Keywords: cardiac...Selection of articles for...Yu CM, Lau CP,...Belardinelli R, Paolini I,...Lisspers J, Sundin O,...Extended search:Higgins HC, Hayes RL,...Lavie CJ, Milani RV....Clinical decision:References |
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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 endothelial function by recruiting collateral coronary arteries or increasing nitric oxide,3 (2) improve myocardial perfusion,4 and (3) prevent the progression of left ventricular diastolic 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 neoinitimal 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 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 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
| Footnotes |
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* Boehringer Ingelheim Pharmaceuticals Inc, a subsidiary of Boehringer Ingelheim Corp, 900 Ridgebury Rd, PO Box 368, Ridgefield, CT 06877-0368. 
Ovid Technologies, 333 Seventh Ave, 20th Floor, New York, NY 10001.
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TopExamination and evaluation:Databases used for search:Initial Keywords: cardiac...Selection of articles for...Yu CM, Lau CP,...Belardinelli R, Paolini I,...Lisspers J, Sundin O,...Extended search:Higgins HC, Hayes RL,...Lavie CJ, Milani RV....Clinical decision:References |
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