Early hybrid cardiac rehabilitation in congenital heart disease: the QUALIREHAB trial

Abstract

Background and aims: Cardiopulmonary fitness in congenital heart disease (CHD) decreases faster than in the general population resulting in impaired health-related quality of life (HRQoL). As the standard of care seems insufficient to encourage and maintain fitness, an early hybrid cardiac rehabilitation programme could improve HRQoL in CHD.

Methods: The QUALIREHAB multicentre, randomized, controlled trial evaluated and implemented a 12-week centre- and home-based hybrid cardiac rehabilitation programme, including multidisciplinary care and physical activity sessions. Adolescent and young adult CHD patients with impaired cardiopulmonary fitness were randomly assigned to either the intervention (i.e. cardiac rehabilitation) or the standard of care. The primary outcome was the change in HRQoL from baseline to 12-month follow-up in an intention-to-treat analysis. The secondary outcomes were the change in cardiovascular parameters, cardiopulmonary fitness, and mental health.

Results: The expected number of 142 patients was enroled in the study (mean age 17.4 ± 3.4 years, 52% female). Patients assigned to the intervention had a significant positive change in HRQoL total score [mean difference 3.8; 95% confidence interval (CI) 0.2; 7.3; P = .038; effect size 0.34], body mass index [mean difference -0.7 kg/m2 (95% CI -1.3; -0.1); P = .022; effect size 0.41], level of physical activity [mean difference 2.5 (95% CI 0.1; 5); P = .044; effect size 0.39], and disease knowledge [mean difference 2.7 (95% CI 0.8; 4.6); P = .007; effect size 0.51]. The per-protocol analysis confirmed these results with a higher magnitude of differences. Acceptability, safety, and short-time effect of the intervention were good to excellent.

Conclusions: This early hybrid cardiac rehabilitation programme improved HRQoL, body mass index, physical activity, and disease knowledge, in youth with CHD, opening up the possibility for the QUALIREHAB programme to be rolled out to the adult population of CHD and non-congenital cardiac disease.

Keywords: Congenital heart defect; Exercise therapies; Patient education; Physical activity; Physical fitness; Quality of life.

Structured Graphical Abstract

The long-term beneficial effect of the 12-week centre-based and home-based hybrid cardiac rehabilitation programme on adolescents and young adults with CHD was observed on HRQoL (primary outcome), BMI, physical activity, and disease knowledge, opening up the possibility for the QUALIREHAB programme to be rolled out to the adult population of CHD and non-congenital cardiac disease. BMI, body mass index; CHD, congenital heart disease; HRQoL, health-related quality of life.

Figure 1

The QUALIREHAB intervention. The 12-week hybrid cardiac rehabilitation programme comprises a multidisciplinary initiation week (‘Week 1’) in a rehabilitation centre (hospital symbol), two sessions of 1-h exercise training per week for 11 weeks (Week 2 to Week 12) delivered by an adapted physical activity educator (house symbol), and 3 days of reinforcement session in the rehabilitation centre (hospital symbol). APA, adapted physical activity

Figure 2

Flowchart. CONSORT diagram

Figure 3

Change in health-related quality of life. This figure summarizes the change in primary outcome (self-reported total health-related quality of life score) and other self-reported health-related quality of life components between baseline and 12-month follow-up. For both intervention and control groups, bar plots represent the mean values of change adjusted on baseline health-related quality of life value, age, and sex. Error bars represent the standard error of the mean. The mean values of change are also indicated on the right of the graph