title: Exercise training improves exercise capacity and quality of life after transcatheter aortic valve implantation: A randomized pilot trial.
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.
  
  
  BACKGROUND
  Clinicaltrials.govNCT01935297.
authors.affiliation: Department of Prevention, Rehabilitation and Sports Medicine, Klinikum rechts der Isar, Technische Universität München, Munich, Germany. Electronic address: pressler@sport.med.tum.de.
authors.forename: Axel
authors.initials: A
authors.lastname: Pressler
authors.affiliation: Department of Prevention, Rehabilitation and Sports Medicine, Klinikum rechts der Isar, Technische Universität München, Munich, Germany.
authors.forename: Jeffrey W
authors.initials: JW
authors.lastname: Christle
authors.affiliation: Department of Prevention, Rehabilitation and Sports Medicine, Klinikum rechts der Isar, Technische Universität München, Munich, Germany.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Lechner
authors.affiliation: Department of Prevention, Rehabilitation and Sports Medicine, Klinikum rechts der Isar, Technische Universität München, Munich, Germany.
authors.forename: Viola
authors.initials: V
authors.lastname: Grabs
authors.affiliation: Institute for Medical Statistics and Epidemiology, Klinikum rechts der Isar, Technische Universität München, Munich, Germany.
authors.forename: Bernhard
authors.initials: B
authors.lastname: Haller
authors.affiliation: Department of Pneumology, University Hospital Freiburg, Freiburg, Germany.
authors.forename: Ina
authors.initials: I
authors.lastname: Hettich
authors.affiliation: Cardiology Department, Munich University Clinic, Munich, Germany.
authors.forename: David
authors.initials: D
authors.lastname: Jochheim
authors.affiliation: Cardiology Department, Munich University Clinic, Munich, Germany; DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, Germany.
authors.forename: Julinda
authors.initials: J
authors.lastname: Mehilli
authors.affiliation: Clinic for Cardiovascular Surgery, German Heart Center Munich, Munich, Germany.
authors.forename: Rüdiger
authors.initials: R
authors.lastname: Lange
authors.affiliation: Clinic for Cardiovascular Surgery, German Heart Center Munich, Munich, Germany.
authors.forename: Sabine
authors.initials: S
authors.lastname: Bleiziffer
authors.affiliation: 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.
authors.forename: Martin
authors.initials: M
authors.lastname: Halle
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000601:surgery*; D005080:Exercise Test / Q000379:methods; D005081:Exercise Therapy / Q000009:adverse effects / Q000379:methods; D017079:Exercise Tolerance / Q000502:physiology; D005260:Female; D005858:Germany; D054624:Health Status Disparities; D006801:Humans; D008297:Male; D053580:Muscle Strength / Q000502:physiology*; D010043:Outcome and Process Assessment, Health Care; D010865:Pilot Projects; D011183:Postoperative Complications / Q000503:physiopathology / Q000517:prevention & control / Q000523:psychology; D011788:Quality of Life; D065467:Transcatheter Aortic Valve Replacement / Q000009:adverse effects / Q000379:methods