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Traditional versus extended hybrid cardiac rehabilitation based on the continuous care model for patients who have undergone coronary artery bypass surgery in a middle-income country: a randomized controlled trial
Pakrad F, Ahmadi F, Grace SL, Oshvandi K, Kazemnejad A
Archives of Physical Medicine and Rehabilitation 2021 Nov;102(11):2091-2101
clinical trial
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVE: To compare traditional (1-month supervised) versus hybrid cardiac rehabilitation (CR; usual care) with an additional 3 months offered remotely based on the continuous care model (intervention) in patients who have undergone coronary artery bypass graft (CABG). DESIGN: Randomized controlled trial, with blinded outcome assessment. SETTING: A major heart center in a middle-income country. PARTICIPANTS: Of 107 eligible patients who were referred to CR during the period of study, 82.2% (N = 88) were enrolled (target sample size). Participants were randomly assigned 1:1 (concealed; 44 per parallel arm). There was 92.0% retention. INTERVENTIONS: After CR, participants were given a mobile application and communicated biweekly with the nurse from months 1 to 4 to control risk factors. MAIN OUTCOME MEASURES: Quality of life (QOL, Short Form-36, primary outcome); functional capacity (treadmill test); and the Depression, Anxiety and Stress Scale were evaluated pre-CR, after 1 month, and 3 months after CR (end of intervention), as well as rehospitalization. RESULTS: The analysis of variance interaction effects for the physical and mental component summary scores of QOL were < 0.001, favoring intervention (per protocol); there were also significant increases from pre-CR to 1 month, and from 1 month to the final assessment in the intervention arm (p < 0.001), with change in the control arm only to 1 month. The effect sizes were 0.115 and 0.248, respectively. Similarly, the interaction effect for functional capacity was significant (p < 0.001), with a clinically significant 1.5 metabolic equivalent of task increase in the intervention arm. There were trends for group effects for the psychosocial indicators, with paired t tests revealing significant increases in each at both assessment points in the intervention arm. At 4 months, there were 4 (10.3%) rehospitalizations in the control arm and none in intervention (p = 0.049). Intended theoretical mechanisms were also affected by the intervention. CONCLUSIONS: Extending CR in this accessible manner, rendering it more comprehensive, was effective in improving outcomes.

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