Protein and Exercise to Reverse Frailty in Older Men and Women Undergoing Transcatheter Aortic Valve Replacement: Design of the PERFORM-TAVR Trial.

Despite the high procedural success of transcatheter aortic valve replacement (TAVR), 2 out of 5 older adults report poor physical performance and health-related quality of life (HRQOL) in the ensuing months, particularly those with frailty. There has yet to be a trial examining the synergistic effects of exercise and protein supplementation to counteract frailty and improve patient-centred outcomes following TAVR. The PERFORM-TAVR trial is a multicentre parallel-group randomised clinical trial that is enrolling 200 frail older adults ≥ 70 years of age undergoing TAVR. Patients will be randomly allocated to 1 of 2 treatment groups: standard-of-care lifestyle education (control group) or protein-rich oral nutritional supplement for 4 weeks before TAVR with the addition of home-based supervised exercise sessions for 12 weeks after TAVR (intervention group). The primary outcome will be physical performance as measured by a blinded observer using the Short Physical Performance Battery at 3 months. Secondary outcomes at 3, 6, and 12 months will include HRQOL, as measured by the Short-Form 36 Physical and Mental Component summary scores, and a composite safety end point. The PERFORM-TAVR trial is testing a novel frailty intervention in older adults undergoing TAVR to optimise recovery and downstream HRQOL. This represents a potential paradigm shift that highlights the value of assessing and treating patients' frailty in parallel with their underlying heart valve disease. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03522454.

The association between sleep disturbance, depressive symptoms, and health-related quality of life among cardiac rehabilitation participants.

PURPOSE: Recent guidelines from the Canadian Association of Cardiac Rehabilitation highlight the importance of addressing sleep disturbance among participants of cardiac rehabilitation (CR) programs. The primary objective of this study was to examine the relationship between depressive symptoms, health-related quality of life, and sleep disturbance in CR participants. The secondary objective was to estimate the prevalence of sleep disturbance among CR participants with and without depressive symptoms and explore demographic, medical, and psychological predictors of poor sleep quality. METHODS: Cardiac rehabilitation participants (N = 259) were included in this study. Participants completed a standardized questionnaire package including demographic, health-related, and psychosocial measures. Physiologic and anthropometric measurements were taken at baseline. Descriptive statistics were calculated for all variables, and data were analyzed using multivariate logistic regression. RESULTS: Poor sleep quality was reported by 52% of participants in the sample, and 47% of participants in the sample reported experiencing at least mild depressive symptoms. Poor sleep occurred more often in individuals with depressive symptoms, and after adjustment for medical factors and health-related quality of life, participants with symptoms of depression were still more likely to experience sleep disturbance than those without depressive symptoms (OR = 2.80; 95% CI, 1.37-5.77). An important gender difference emerged in the relationship between symptoms of depression and sleep disturbance. CONCLUSION: Among participants of a CR program, disturbed sleep was strongly associated with depressive symptoms and decreased health-related quality of life. Results demonstrate the importance of sleep evaluation in CR programs.