Axel Pressler1, Jeffrey W Christle2, Benjamin Lechner2, Viola Grabs2, Bernhard Haller3, Ina Hettich4, David Jochheim5, Julinda Mehilli6, Rüdiger Lange7, Sabine Bleiziffer7, Martin Halle8. 1. Department of Prevention, Rehabilitation and Sports Medicine, Klinikum rechts der Isar, Technische Universität München, Munich, Germany. Electronic address: pressler@sport.med.tum.de. 2. Department of Prevention, Rehabilitation and Sports Medicine, Klinikum rechts der Isar, Technische Universität München, Munich, Germany. 3. Institute for Medical Statistics and Epidemiology, Klinikum rechts der Isar, Technische Universität München, Munich, Germany. 4. Department of Pneumology, University Hospital Freiburg, Freiburg, Germany. 5. Cardiology Department, Munich University Clinic, Munich, Germany. 6. Cardiology Department, Munich University Clinic, Munich, Germany; DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, Germany. 7. Clinic for Cardiovascular Surgery, German Heart Center Munich, Munich, Germany. 8. Department of Prevention, Rehabilitation and Sports Medicine, Klinikum rechts der Isar, Technische Universität München, Munich, Germany; DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, Germany; Else Kröner-Fresenius-Zentrum am Klinikum rechts der Isar, Technische Universität München, Munich, Germany.
Abstract
BACKGROUND:Transcatheter aortic valve implantation (TAVI) is increasingly applied for aortic stenosis in elderly patients with impaired mobility and reduced quality of life. These patients may particularly benefit from postinterventional exercise programs, but no randomized study has evaluated the safety and efficacy of exercise in this population. METHODS: In a prospective pilot study, 30 patients after TAVI (mean age, 81±6 years, 44% female, 83±34 days postintervention) were randomly allocated 1:1 to a training group (TG) performing 8 weeks of supervised combined endurance and resistance exercise or to usual care. The formal primary efficacy end point was between-group difference in change in peak oxygen uptake assessed by cardiopulmonary exercise testing; secondary end points included muscular strength, 6-minute walk distance, and quality of life (Kansas City Cardiomyopathy Questionnaire and Medical Outcomes Study 12-Item Short-Form Health Survey questionnaires). Safety was assessed by documenting training-related adverse events, prosthesis, and renal function. RESULTS: Significant changes in favor of TG were observed for peak oxygen uptake (group difference, 3.7 mL/min per kg [95% CI, 1.1-6.3; P=.007]), muscular strength (bench press, 6 kg [95% CI, 3-10; P=.002]; rowing, 7 kg [95% CI, 3-11; P<.001]; pulldown, 9 kg [95% CI, 4-14; P=.001]; shoulder press, 5 kg [95% CI, 1-8; P=.008]; leg press, 17 kg [95% CI 6-28; P=.005]), components of quality of life (Kansas City Cardiomyopathy Questionnaire physical limitation, 19.2 [95% CI, 4.1-34.2; P=.015]; symptom burden, 12.3 [95% CI, 0.5-24.0; P=.041]; clinical summary, 12.4 [3.4-21.4; P=.009]), but not for other questionnaire subscales and 6-minute walk distance (15 m [95% CI, -23 to 53; P=.428]). Three dropouts unrelated to exercise occurred (TG=2; usual care,=1); prosthesis and renal function were not affected by the exercise intervention. CONCLUSIONS: In patients after TAVI, exercise training appears safe and highly effective with respect to improvements in exercise capacity, muscular strength, and quality of life. CLINICAL TRIAL REGISTRATION: Clinicaltrials.govNCT01935297. Copyright Â
RCT Entities:
BACKGROUND: Transcatheter aortic valve implantation (TAVI) is increasingly applied for aortic stenosis in elderly patients with impaired mobility and reduced quality of life. These patients may particularly benefit from postinterventional exercise programs, but no randomized study has evaluated the safety and efficacy of exercise in this population. METHODS: In a prospective pilot study, 30 patients after TAVI (mean age, 81±6 years, 44% female, 83±34 days postintervention) were randomly allocated 1:1 to a training group (TG) performing 8 weeks of supervised combined endurance and resistance exercise or to usual care. The formal primary efficacy end point was between-group difference in change in peak oxygen uptake assessed by cardiopulmonary exercise testing; secondary end points included muscular strength, 6-minute walk distance, and quality of life (Kansas City Cardiomyopathy Questionnaire and Medical Outcomes Study 12-Item Short-Form Health Survey questionnaires). Safety was assessed by documenting training-related adverse events, prosthesis, and renal function. RESULTS: Significant changes in favor of TG were observed for peak oxygen uptake (group difference, 3.7 mL/min per kg [95% CI, 1.1-6.3; P=.007]), muscular strength (bench press, 6 kg [95% CI, 3-10; P=.002]; rowing, 7 kg [95% CI, 3-11; P<.001]; pulldown, 9 kg [95% CI, 4-14; P=.001]; shoulder press, 5 kg [95% CI, 1-8; P=.008]; leg press, 17 kg [95% CI 6-28; P=.005]), components of quality of life (Kansas City Cardiomyopathy Questionnaire physical limitation, 19.2 [95% CI, 4.1-34.2; P=.015]; symptom burden, 12.3 [95% CI, 0.5-24.0; P=.041]; clinical summary, 12.4 [3.4-21.4; P=.009]), but not for other questionnaire subscales and 6-minute walk distance (15 m [95% CI, -23 to 53; P=.428]). Three dropouts unrelated to exercise occurred (TG=2; usual care,=1); prosthesis and renal function were not affected by the exercise intervention. CONCLUSIONS: In patients after TAVI, exercise training appears safe and highly effective with respect to improvements in exercise capacity, muscular strength, and quality of life. CLINICAL TRIAL REGISTRATION: Clinicaltrials.govNCT01935297. Copyright Â
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