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Evidence-based Practice |
1 From the Vascular Laboratory (S.S.) and Department of Surgery (H.F.V., P.T.d.H.), Ikazia Hospital, Rotterdam, the Netherlands; Departments of Epidemiology and Biostatistics and Radiology, Erasmus University Medical Center Rotterdam, EE2140a, PO Box 1738, 3000 DR Rotterdam, the Netherlands (J.L.B., M.G.M.H.); Massachusetts General HospitalInstitute for Technology Assessment, Harvard Medical School, Boston, Mass (J.L.B.); and Harvard School of Public Health, Boston, Mass (M.G.M.H.). Received March 9, 2004; revision requested May 20; revision received July 6; accepted August 5. Address correspondence to M.G.M.H. (e-mail: m.hunink@erasmusmc.nl).
| ABSTRACT |
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MATERIALS AND METHODS: Articles published between January 1980 and February 2003 were included if patients had intermittent claudication treated with exercise training or angioplasty and if both functional capacity and quality-of-life scores from Medical Outcomes Study 36-Item Short Form health survey were reported for at least 3 months of follow-up. Data were pooled by using a random effects model and weighted means. Pooled results were compared between the treatment groups by using the
2 test and the Student t test (
= .05, two sided).
RESULTS: In the analyses, five studies (202 patients) were included in the exercise group, and three studies (470 patients), in the angioplasty group. At 3 months of follow-up, the ankle-brachial index was significantly improved in the angioplasty group (mean change, 0.18; P < .01) but not in the exercise group (mean change, 0.01; P = .29). At 3 months, quality of life was significantly improved with regard to ratings of physical functioning and bodily pain in the exercise group (mean change, 18 and 10, respectively; P < .01) and physical role functioning in the angioplasty group (mean change, 30; P = .03). Mean change in ankle-brachial index significantly differed between the two treatment groups at 3 and 6 months (P < .01); mean change in quality-of-life scores did not.
CONCLUSION: Improvement in quality of life was demonstrated after both exercise training and angioplasty, whereas functional capacity showed significant improvement after angioplasty. The ankle-brachial index significantly differed between the two treatment groups at 3 and 6 months, whereas the quality-of-life scores did not.
© RSNA, 2005
| INTRODUCTION |
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In 1957, Foley (4) described the beneficial effects of daily walks and physical training in patients with intermittent claudication. Several subsequent reports (57) confirmed that exercise training led to an improvement in the walking ability of patients with intermittent claudication. It has been shown to significantly improve both the onset of leg discomfort (initial walking distance) and the point at which the pain becomes unbearable and forces the patient to stop walking (maximum walking distance) (8,9). PTA became available in 1964 and is currently an established treatment option for patients with intermittent claudication (10). Low complication rates (4%5%) and 5-year patency rates of 80% for aortoiliac disease and 60% for femoropopliteal disease were reported for PTA (1114). This technique has been popularized as an inexpensive, effective, and simple method (1517).
In recent years, quality of life has been extensively used as a parameter for assessing and expressing the success of the outcome in patients with intermittent claudication (18). The TransAtlantic Inter-Society Consensus stated that if quality of life could be accurately assessed, it would be the ideal primary end point (19). Furthermore, the relationship between functional capacity and quality of life is complex and contradictory, and both therefore should be considered in the assessment of outcome (20,21).
There remains uncertainty surrounding the effectiveness of the treatment strategies in patients with intermittent claudication. Thus, the objective of our study was to systematically review the published data about the short- and long-term effects of exercise training and angioplasty on functional capacity and quality of life of patients with intermittent claudication.
| MATERIALS AND METHODS |
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A literature search was performed by using MEDLINE and the reference lists in articles. Further searches were performed by using the same keywords in the Cochrane Central Register of Controlled Trials, Cochrane Anesthesia Group Specialized Register, Cumulative Index to Nursing and Allied Health Literature, and PiCarta.
The reviewers used the English-language medical literature published in 1980 or later (22). Published studies of PTA dated from 1980, and to find contemporary controls between the exercise group and the PTA group, we restricted our review to this period. Randomized controlled trials, prospective cohort studies, and retrospective cohort studies were included, while case reports and reviews were excluded. Key words were ("intermittent claudication" OR "claudicants") AND ("angioplasty" OR "PTA" OR "stent placement" OR "balloon dilation" OR "exercise" OR "gymnastics" OR "walking" OR "training") AND ("quality of life" OR "QoL" OR "health status") AND ("functional capacity" OR "ankle brachial index" OR "walking distance") AND ("vascular peripheral" OR "arterial peripheral"). The studies were included if they met the following criteria: Patients with intermittent claudication were included and were treated with either exercise training (walking or gymnastics) or with PTA with or without stent placement in lesions in the aortoiliac or femoropopliteal arterial segments. Both functional capacity as demonstrated by walking distance (on a treadmill or as reported by the patient) or ABI, and quality-of-life scores (generic or disease specific) for at least 3 months of follow-up, were reported. Reports about PTA studies that also included patients with critical ischemia were excluded from our analysis if the outcome results were not reported separately for patients with critical ischemia and for those with intermittent claudication (23,24). When the same group of investigators reported their results in various journals, all reports were examined for similarities and completeness, and the results were treated as those of a single study in our review (25,26).
Data were abstracted independently by the same two authors who selected the publications. The following parameters were recorded: study design; patient characteristics; measures of severity of claudication, such as Rutherford classification, walking distance, and ABI; type of exercise training or intervention; outcomes; and follow-up results reported by using standardized forms. The exercise training programs were evaluated by the same two authors, and discrepancies between the evaluations were resolved with consensus.
Functional Capacity and Quality of Life
The ABI at rest and the maximum treadmill walking distance are the most frequently reported outcomes of functional capacity. The ABI is defined as the ratio of the systolic blood pressure measured at one of the ankle arteries to the systolic blood pressure measured at the brachial artery (9). The most efficient and reliable test for the determination of the maximum walking distance is considered to be a treadmill test (27).
The Medical Outcomes Study 36-Item Short Form (SF-36) health survey was most frequently used in studies in which investigators evaluated quality of life after exercise training or PTA in patients with intermittent claudication. The SF-36 survey was developed to evaluate the physical, social, and physical role functioning of patients and to elicit their perceptions of their general health and well-being in eight dimensions (28). Each dimension is subjectively rated by the respondent and assigned a score on a scale of 0100 in which 100 indicates best functioning or well-being. In previous studies, it was demonstrated that the dimensions of physical functioning, bodily pain, and physical role functioning showed the most substantial improvement after treatment in patients with intermittent claudication (29). In this study, therefore, we concentrated on the following three dimensions: physical functioning (limitation of usual activities because of a physical problem), physical role functioning (limitation of usual role activities because of a physical problem), and bodily pain (pain or discomfort in the body). In addition, we added the dimension of general health. If data from the SF-36 survey were not reported but data from SF-20 (a shorter version of the same survey) were available, the SF-20 data were used. For studies of exercise training, data beyond 6 months of follow-up were not available, and for studies of PTA, data at 6 months were poor. The weighted means for functional capacity and the quality-of-life scores in the PTA studies did not change significantly between 3 months and 12 months of follow-up. Therefore, to improve the comparison between the exercise training and PTA studies at 6 months of follow-up, we used the data obtained at 12 months of follow-up to calculate the weighted means at 6 months.
Statistical Analysis of Data
To pool data for discrete variables such as male sex, cardiac disease, hypertension, diabetes mellitus, pulmonary disease, hyperlipidemia, stroke, history of smoking, and current smoking, the random effects model described by Laird and Mosteller (30) was used. The random effects model takes into account the variance between studies, as well as that within studies. Because of the lack of reported data for variance around the means of continuous variables such as age, ABI, walking distance, and quality-of-life score, we were unable to use the random effects model to pool the continuous variables. Therefore, we calculated the weighted mean and 95% confidence interval (CI) for these variables.
Within the treatment study groups of exercise and PTA, the dichotomous baseline characteristics of all patients in the included studies were tested for homogeneity by using the
2 test (statistical significance level,
= .05). Differences in pooled patient characteristics between the studies of PTA and those of exercise were tested with the
2 test and with the paired (two-sample) Student t test (statistical significance level,
= .05, two sided).
Improvements in functional capacity and quality of life between baseline and 3 months of follow-up and between baseline and 6 months of follow-up within the exercise study group and within the PTA study group were calculated and tested for statistical significance (paired Student t test,
= .05).
A funnel plot was constructed to detect the presence of publication bias (ie, bias resulting from the greater likelihood of publication for studies reporting a positive result than for studies reporting a negative result) (31). In the current study, we plotted the number of patients who underwent exercise training or PTA as a function of the mean change in physical functioning (ie, baseline data vs data at 3 months of follow-up [or 6 months of follow-up, if 3-month follow-up data were unavailable]). If there is no publication bias, the distribution of the data points will be symmetric and shaped like an inverted V.
The analyses were performed with software (Excel, release 2003, Microsoft Corporation, Redmond, Wash; SPSS, release 11.0.1, SPSS, Chicago, Ill).
| RESULTS |
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Many baseline demographic and patient characteristics were not reported (Table 3). The percentage of male patients was 69% in the exercise training group and 73% in the PTA group (P = .56). The mean age of patients in the exercise training group also was not significantly different from that in the PTA group (68 vs 63 years, respectively; P = .33).
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Between the two treatment groups, patient characteristics were similar, except in regard to the percentages of patients with hypertension and stroke, which were significantly higher in the exercise training group than in the PTA group (64% vs 31%, P = .01, for hypertension; 23% vs 11%, P = .03, for stroke).
The weighted mean ABI at baseline in the exercise training group was lower than that in the PTA group (0.64 vs 0.71), but the difference was not statistically significant (P = .13). Also, no statistically significant difference was found in the weighted mean for maximum walking distance at baseline between the exercise training group and the PTA group (289 m vs 155 m, respectively; P = .11).
To detect publication bias, we constructed two funnel plots: one for the PTA group, and one for the exercise training group. Neither plot appeared symmetric. There were too few studies, however, to permit a proper evaluation of publication bias.
Exercise Training Programs
The exercise training programs differed across the studies (Table 4). These differences included variations in supervision, intensity, frequency, duration, and type of exercise. Of the five studies included in the exercise training group, one study involved supervised training, one study involved unsupervised training, and three studies each included one group with supervised training and one group with unsupervised training. Supervision implied that patients participated in a structured hospital-based exercise program.
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In the four unsupervised programs, the type and intensity of contact with the patient varied from weekly or monthly conversations by telephone to weekly lectures and instructions or to no contact during the exercise program. In one study, patients were asked to maintain a weekly log. The mean compliance of the patients in the unsupervised programs varied from 78% to 100% (in one study, compliance was not reported).
Functional Capacity
All studies reported the ABI during rest at baseline (Table 5). The maximum walking distance was determined in two of the three studies in the PTA group and in four of the five studies in the exercise training group. It should be noted that the test duration and the speed and grade settings used during the treadmill test to determine the maximum walking distance varied between studies. Grades of 0%10% were used with speeds of 12 mph (1.63.2 km/h), either fixed or increased in increments of 1 or 2 mph.
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The difference between the two treatment groups in ABI at 3 and 6 months was significant (P < .01 and P = .02, respectively). Although the weighted means of the maximum walking distance at baseline were not significantly different between the treatment groups, we did not compare this outcome of functional capacity during follow-up, because of the variation in measurements of the maximum walking distance among the studies.
Quality of Life
In the exercise training group, the mean scores for the dimensions of physical functioning, physical role functioning, bodily pain, and general health demonstrated improvement at 3 and 6 months (Fig 2, Table 6). However, the improvement was statistically significant only for the dimensions of physical functioning and bodily pain at 3 months and for the dimension of bodily pain at 6 months. The effect of treatment was highest for the dimension of physical functioning at 3 months (P < .01).
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There were no significant differences at baseline between the two treatment groups with regard to the dimensions of physical functioning, physical role functioning, bodily pain, and general health. In addition, no significant differences in the mean change of quality of life were demonstrated between the two treatment groups during follow-up.
| DISCUSSION |
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To our knowledge, no review has been published in which exercise training and PTA are compared with regard to both functional capacity and quality of life. In addition, results have been published from only two randomized controlled trials in which exercise training and PTA were directly compared (32,39). These studies, however, did not meet our inclusion criteria; one study did not report both functional capacity and quality of life, and the other study did not use the SF-36 survey for quality-of-life assessment. The results of one of these studies showed that, at 12 months of follow-up, patients with mild or moderate intermittent claudication who underwent supervised exercise training had greater symptomatic improvement than did patients who underwent PTA (39). Results of the other study showed no significant difference in quality of life between control subjects (patients after unsupervised exercise training) and the PTA group after 2 years of follow-up (32,40). The PTA group, however, included substantially fewer patients with arterial occlusion and/or severe stenosis than did the exercise group. Data from these two randomized controlled trials were collected for a review, but the trials were relatively small, and the results must be interpreted with caution (41).
Unfortunately, one of the limitations in our systematic review was that data for both functional capacity and quality of life were inconsistently reported. In particular, data about long-term functional capacity and quality-of-life outcomes for exercise training after 6 months were lacking, and, in consequence, the deleterious effect of postangioplasty restenoses must have been somewhat underestimated. Furthermore, many baseline demographic and patient characteristics that may have been relevant to a comparison between treatment groups, such as the disease location (aortoiliac vs femoropopliteal arteries), smoking history, and the use of medications (eg, cilostazol, statins), were not reported.
Another limitation, which became apparent after review of the exercise training programs, is the lack of standardization in the different components of exercise training. This limitation hampered the comparison of the reported results of the different studies. Investigators in the different exercise training studies evaluated the effectiveness of supervised or unsupervised exercise programs, but the relative effectiveness of these programs is still controversial. Some studies, particularly those performed in Europe, have shown good results with a home-based exercise program (42,43). Other studies, however, have shown little benefit for this type of program (37), whereas supervised exercise has provided consistent clinical improvement in almost every study (8,3638). There is also a lack of standardization of the treadmill test with regard to the use of fixed loading or graded loading, different speeds, and different maximum walking times. A longer walking distance was used in the exercise studies than in the PTA studies. These different protocols could help to explain the different maximum walking distances reported at baseline and during follow-up between the two treatments. The existence of this bias hampered comparison between the two treatments.
Another limitation of our study was the potential publication bias. However, studies in the exercise training group were relatively small, and there were only four studies in the PTA group, which limits power for detection of publication bias. Another limitation of the current systematic review is that the included studies were not randomized controlled trials in which exercise training was compared with PTA. This implies that the population undergoing exercise training may differ from the population undergoing PTA. Nevertheless, in our study, most patient characteristics were not significantly different between the treatment groups. Even though randomized controlled clinical trials are supposed to be the superior mode for evaluating and comparing different treatment modalities, they too have limitations (44). In general, a randomized trial is performed in an ideal setting, with a selected, usually small, patient population, which may hamper generalization of the results. Systematic reviews of cohort studies, on the other hand, may reflect general clinical practice and provide additional data about a larger number of patients.
There is still no evidence that quality of life for patients with intermittent claudication is significantly better after PTA than after exercise training after more than 6 months. Patients with intermittent claudication are often treated conservatively; however, various exercise training programs are used (3438). In addition, the definitions of supervised exercise and unsupervised exercise vary widely in European countries. Therefore, a standardized exercise training program with measurement of the maximum walking distance according to a universally accepted standard would be desirable. Over the past decade, PTA has been more widely used in patients with intermittent claudication, mainly because of its low associated morbidity and mortality (1113). PTA, however, is a local form of treatment, and it is therefore not surprising that patients may experience relapse after PTA, with ipsilateral or contralateral symptoms representing progressive disease at other sites; the benefit with PTA may be a short-term effect. A randomized controlled trial of both treatments with long-term follow-up will enable further evaluation of effectiveness and determination of functional capacity and quality of life after more than 6 months.
In conclusion, our results demonstrate an improvement in quality of life after exercise training, whereas both functional capacity and quality of life showed significant improvement after PTA. ABIs in the PTA group were significantly higher than those in the exercise training group at 3 and 6 months, whereas the mean change in quality-of-life scores was not significantly different between the two groups during follow-up. Despite the limitations outlined, our analysis has shown the best evidence that we have. This is what we know at this point in time, and more needs to be done.
| FOOTNOTES |
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Authors stated no financial relationship to disclose.
Author contributions: Guarantor of integrity of entire study, J.L.B.; study concepts, S.S., J.L.B., P.T.d.H., H.F.V.; study design, S.S., J.L.B.; literature research, S.S., J.L.B.; data acquisition, S.S., J.L.B.; data analysis/interpretation, S.S., J.L.B., M.G.M.H.; statistical analysis, S.S., J.L.B.; manuscript preparation and editing, S.S.; manuscript definition of intellectual content, S.S., J.L.B., M.G.M.H.; manuscript revision/review and final version approval, all authors
| REFERENCES |
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