Abstract 13292: Comprehensive Cardiac Rehabilitation versus Treatment as Usual For Implantable Cardioverter Defibrillator Recipients Improves Exercise Capacity, General Health and Mental Health - Mixed Methods Approach Embedding Data from a Randomised Clinical Trial with Qualitative Data

Abstract

Objective -to assess a comprehensive cardiac rehabilitation intervention including exercise training and psycho-education versus ‘treatment as usual’ in patients treated with implantable cardioverter defibrillator (ICD). The hypothesis was that the intervention would improve physical capacity, perceived health and the number of ICD shocks.

Design Mixed methods embedded experimental design, combining the data from the RCT with qualitative interviews.

Participants 196 patients with first time ICD implantation (mean age 58 years; 79% men) were randomised (1:1) to rehabilitation versus ‘treatment as usual’. 144 participants completed the 12 month follow-up. Ten patients from the rehabilitation group were interviewed after the intervention.

Intervention Twelve weeks of exercise and one year of psycho-educational follow up focusing on modifiable factors associated with poor outcomes.

Main outcome measures Due to the complexity of the intervention two primary outcomes peak oxygen uptake (VO₂) and general health score (SF-36) were used. Post hoc analyses included assessments of SF-36 and ICD shock history.

Results Comprehensive cardiac rehabilitation significantly increased VO₂ uptake after exercise training to 20.9 mL/min/kg (95% confidence interval (CI) 19.3 to 22.7) versus 19.5 mL/min/kg (95% CI 18.0 to 21.1) in the control group (uncorrected P=0.003 [multiplicity adjusted P=0.015]). Comprehensive cardiac rehabilitation significantly increased general health at 3 months (mean 63.2 points (95% CI 58.6 to 67.8) versus 63.9 points (95% CI 59.3 to 68.5); at 6 months (mean 66.8 points (95% CI 61.6 to 72.0) versus 61.4 points (95% CI 56.2 to 66.6); and at 12 months (mean 63.2 points (95% CI 57.7 to 68.7) versus 61.9 points (95% CI 56.4 to 67.4) (P=0.015). Explorative analyses showed that that mental component score improved significantly in the rehabilitation group. No significant difference between groups in ICD shock history. The results were further explained by the qualitative findings: patients’ experienced supported coping and regained trust in their bodies.

Conclusion A combined rehabilitation program improves VO₂-uptake and general health. Mental health seems improved and the program is perceived as beneficial through supported coping.