Elsevier

American Heart Journal

Volume 182, December 2016, Pages 44-53
American Heart Journal

Clinical Investigation
Exercise training improves exercise capacity and quality of life after transcatheter aortic valve implantation: A randomized pilot trial

https://doi.org/10.1016/j.ahj.2016.08.007Get rights and content

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.gov NCT01935297.

Section snippets

Study design and population

Safety, applicability, and outcome of regular exercise training after SPORT:TAVI was a prospective, randomized controlled pilot trial that was conducted by 3 centers in Munich, Germany, between October 2012 and April 2014. Patients underwent TAVI either at the German Heart Center Munich or at the University Hospital Munich of the Ludwig-Maximilians-Universität, whereas the supervised exercise training was performed at the Department of Prevention, Rehabilitation and Sports Medicine, Technical

Participant flow and baseline data

The flow of participants through the study is summarized in Figure 1. The mean age of the study population was 81 ± 6 years (range, 71-92), and patients were included 83 ± 34 days (range, 42-132) after intervention. No differences for TG and UC with respect to age, proportion of females, The Society of Thoracic Surgeons mortality risk score, NYHA class, preexisting conditions, and medication were observed (see Table I). No patient had clinically relevant chronic lung disease. Participants had

Discussion

This pilot study showed that an exercise intervention in patients after TAVI, consisting of gradually increasing moderate combined endurance and strength training over 8 weeks, was safe and had no negative effects on prosthesis, renal, or neurohumoral function. It resulted in significant improvements in exercise capacity, muscular strength as well as important aspects of quality of life related to physical function, and symptom burden as compared with usual care.

Alongside interventional and

Conclusions

In this pilot study on exercise after TAVI, 8 weeks of combined endurance and resistance exercise resulted in significant improvements in exercise capacity, muscular strength, and quality of life compared with usual care without affecting cardiac adverse events or prosthesis function. The findings indicate that exercise after TAVI may strongly add to improved functional outcomes beyond the effects of the TAVI procedure itself. Adequately powered randomized trials are warranted to evaluate

References (32)

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All authors have approved the final article.

Conflicts of interest: none.

Grant support: This study received grant support by the German Heart Foundation/German Foundation of Heart Research (Frankfurt, Germany; F/14/12). Author BL received financial support from the German Cardiac Society (Düsseldorf, Germany) via the Otto-Hess-Research-Grant.

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