Effectiveness of supervised exercise, home-based exercise, or walk advice strategies on walking performance and muscle endurance in patients with intermittent claudication (SUNFIT trial): a randomized clinical trial.

AIMS: Supervised exercise is a guideline-recommended treatment in intermittent claudication (IC). Hospital-based supervised exercise programmes (SEPs) are underutilized, while home-based structured exercise programmes (HSEPs) have attracted interest. The results from HSEP in IC are inconsistent and may confer no benefit over walk advice (WA) and be less effective than SEP. The aim of the study was to compare the effectiveness of best medical treatment, including Nordic pole WA alone, or WA + SEP or WA + HSEP for patients with IC. METHODS AND RESULTS: This three-armed, multicentre randomized clinical trial enrolled patients with IC; all patients received best medical treatment including walking poles and the advice of regular Nordic pole walking (WA). For HSEP and SEP, additional exercise programmes were provided. The primarily investigated hypothesis was a non-inferiority analysis of SEP vs. HSEP regarding the 6-min walk test (6MWT) maximum distance, with a pre-defined non-inferiority margin of 50 m. Supporting outcomes included muscle endurance tests and the walking impairment questionnaire. Outcomes were assessed at baseline, 3, 6, and 12 months by a blinded evaluator. Altogether 166 patients (mean age 72 years; 59% males) were randomized. In HSEP and SEP, 24 and 26% patients, respectively, were fully exercise adherent. All three groups improved pain-free walking distance over time, but there were no significant intergroup differences. The intergroup 6MWT difference between SEP and HSEP from 0 to 12 months was -11.6 m, 95% confidence interval: -36.4 to 13.0 m (i.e. within the pre-specified non-inferiority margin). CONCLUSION: The HSEP was non-inferior to SEP in patients with IC. There were no significant differences observed between the three groups at 1 year. REGISTRATION: ClinicialTrials.gov: NCT02341716.

Exercise-based cardiac rehabilitation after acute myocardial infarction in Sweden - standards, costs, and adherence to European guidelines (The Perfect-CR study).

AIMS: Information on standards including structure- and process-based metrics and how exercise-based cardiac rehabilitation (EBCR) is delivered in relation to guidelines is lacking. The aims of the study were to evaluate standards and adherence to guidelines at Swedish CR centers and to conduct a cost analysis of the physiotherapy-related activities of EBCR. METHODS AND RESULTS: EBCR standards at all 78 CR centers in Sweden in 2016 were surveyed. The questions were based on guideline-recommended core components of EBCR for patients after a myocardial infarction (MI). The cost analysis included the identification, quantification, and valuation of EBCR-related cost items. Patients were offered a pre-discharge consultation with a physiotherapist at n = 61, 78% of the centers. A pre-exercise screening visit was routinely offered at n = 64, 82% of the centers, at which a test of aerobic capacity was offered in n = 58, 91% of cases, most often as a cycle ergometer exercise test n = 55, 86%. A post-exercise assessment was offered at n = 44, 56% of the centers, with a functional test performed at n = 30, 68%. Almost all the centers n = 76, 97% offered supervised EBCR programs. The total cost of delivering physiotherapy-related activities of EBCR according to guidelines was approximately 437 euro (4,371 SEK) per patient. Delivering EBCR to one MI patient required 11.25 hours of physiotherapy time. CONCLUSION: While the overall quality of EBCR programs in Sweden is high, there are several areas of potential improvement to reach the recommended European standards across all centers. To improve the quality of EBCR, further compliance with guidelines is warranted.

Test-retest reliability, agreement, and minimal detectable change in the 6-minute walk test in patients with intermittent claudication.

OBJECTIVE: Standardized walk tests are important for objective assessment of walking distance in patients with intermittent claudication (IC). The 6-minute walk test (6MWT) has been suggested to correlate more closely than testing on a treadmill with everyday ambulatory function, but its measurement properties have hardly been studied in IC. The aim of this study was to determine the test-retest reliability, agreement, standard error of measurement (SEM), and minimal detectable change of the 6MWT in patients with IC. METHODS: This reliability and agreement study recruited 102 patients with stable IC (mean age, 72 ± 7.4 years; 43 women) from the vascular surgery outpatient clinic at Sahlgrenska University Hospital in Sweden. The patients performed the 6MWT twice, with at least 30 minutes of rest between tests. To determine test-retest reliability, the intraclass correlation coefficient was calculated. Bland-Altman plots were used to measure agreement. RESULTS: The mean walking distance in both test and retest was 397.8 m (standard deviation, 81.2 m; N = 100), and the individual walking distance varied from 175 to 600 m. Excellent test-retest reliability for the 6MWT (intraclass correlation coefficient, 0.95; 95% confidence interval, 0.9-0.97) was observed. The SEM was 16.6 m (95% confidence interval, 14.6-19.3), the SEM percentage was 4.2%, and the minimal detectable change was 46 m. Five observations (5%) were positioned outside the limits of agreement; there was a small proportional bias, and the scatter of values for differences decreased as the average values increased. CONCLUSIONS: The excellent test-retest reliability implies that it is sufficient for a patient with IC to perform the 6MWT once, at every test occasion. For the individual, an improvement or deterioration in maximum walking distance of >46 m after an intervention would be required to be 95% confident that the change is significant. Being a simple and clinically useful test, the 6MWT can be widely used to evaluate the effects of different interventions in patients with IC.

Reliability of two questionnaires on physical function in patients with stable coronary artery disease.

BACKGROUND: Exercise-based cardiac rehabilitation is highly recommended for patients with coronary artery disease, as it improves physical fitness and reduces mortality and morbidity. Physical fitness per se does not always correlate with the patient's physical function. For this reason, additional measurements of physical function could be included in cardiac rehabilitation programmes to further tailor interventions to suit the individual patient. As a result, reliable measurements to assess physical function are required for patients with coronary artery disease. AIM: The aim of this study was to evaluate the reliability of the Patient-Specific Functional Scale (PSFS) and the Disability Rating Index (DRI) in patients with stable coronary artery disease. MATERIAL: Fifty-one patients (11 women), age 63.9 (SD 7.6) years, with stable coronary artery disease and coronary-angiographic changes indicating an elective percutaneous coronary intervention, were recruited at the Cardiology Department at Sahlgrenska University Hospital, Gothenburg. METHODS: The reliability tests included stability over time, evaluated with a test-retest procedure using the intraclass correlation coefficient (ICC), and internal consistency, measured with Cronbach's alpha and item-total correlation coefficients. RESULTS: Both questionnaires were stable over time (DRI, ICC=0.74, and PSFS, ICC=0.72). The internal consistency for the DRI was good, with a Cronbach's alpha value of > 0.85 for all items. The item-total correlation coefficients presented acceptable values of > 0.40, apart from two items. CONCLUSION: We have provided introductory support for the reliability of the DRI and PSFS questionnaires in patients with stable CAD. These questionnaires can be used to assess physical function and to evaluate the effect of interventions in addition to measuring physical fitness.

Effects of high frequency exercise in patients before and after elective percutaneous coronary intervention.

BACKGROUND: The aim of this study was to evaluate the effects of high frequency exercise for patients before and after an elective percutaneous coronary intervention (PCI), with special reference to maximal aerobic capacity, muscle function, health related quality of life (HRQoL), waist-hip ratio (WHR) and restenosis. METHODS: A randomised, controlled study was performed in Sweden between 2004 and 2006 in thirty-seven patients (five women) with stable coronary artery disease (CAD), age 63.6+/-6.9 years, randomised to either high frequency exercise or control group. The patients in the training group performed three endurance resistance exercises and trained on a cycle ergometer 30 min, 5 times a week for 8 months at 70% of VO(2max). RESULTS: Patients in the training group significantly improved their maximal aerobic capacity (15 (9-46) vs. 8 (0-18)% p