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Hybrid cardiac rehabilitation program in a low-resource setting: a randomized clinical trial [with consumer summary]
Seron P, Oliveros MJ, Marzuca-Nassr GN, Morales G, Roman C, Munoz SR, Galvez M, Latin G, Marileo T, Molina JP, Navarro R, Sepulveda P, Lanas F, Saavedra N, Ulloa C, Grace SL
JAMA Network Open 2024 Jan;7(1):e2350301
clinical trial
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

IMPORTANCE: While effective, cardiovascular rehabilitation (CR) as traditionally delivered is not well implemented in lower-resource settings. OBJECTIVE: To test the noninferiority of hybrid CR compared with traditional CR in terms of cardiovascular events. DESIGN, SETTING, AND PARTICIPANTS: This pragmatic, multicenter, parallel arm, open-label randomized clinical trial (the Hybrid Cardiac Rehabilitation Trial (HYCARET)) with blinded outcome assessment was conducted at 6 referral centers in Chile. Adults aged 18 years or older who had a cardiovascular event or procedure, no contraindications to exercise, and access to a mobile telephone were eligible and recruited between April 1, 2019, and March 15, 2020, with follow-up until July 29, 2021. INTERVENTIONS: Participants were randomized 1:1 in permuted blocks to the experimental arm, which received 10 center-based supervised exercise sessions plus counseling in 4 to 6 weeks and then were supported at home via telephone calls and text messages through weeks 8 to 12, or the control arm, which received the standard CR of 18 to 22 sessions with exercises and education in 8 to 12 weeks. MAIN OUTCOMES AND MEASURES: The primary outcome was cardiovascular events or mortality. Secondary outcomes were quality of life, return to work, and lifestyle behaviors measured with validated questionnaires; muscle strength and functional capacity, measured through physical tests; and program adherence and exercise-related adverse events, assessed using checklists. RESULTS: A total of 191 participants were included (mean (SD) age 58.74 (9.80) years; 145 (75.92%) male); 93 were assigned to hybrid CR and 98 to standard CR. At 1 year, events had occurred in 5 unique participants in the hybrid CR group (5.38%) and 9 in the standard CR group (9.18%). In the intention-to-treat analysis, the hybrid CR group had 3.80% (95% CI -11.13% to 3.52%) fewer cardiovascular events than the standard CR group, and relative risk was 0.59 (95% CI 0.20 to 1.68) for the primary outcome. In the per-protocol analysis at different levels of adherence to the intervention, all 95% CIs crossed the noninferiority boundary (eg, 20% adherence absolute risk difference -0.35% (95% CI -7.56% to 6.85%); 80% adherence absolute risk difference 3.30% (95% CI -3.70% to 10.31%)). No between-group differences were found for secondary outcomes except adherence to supervised CR sessions (79.14% (736 of 930 supervised sessions) in the hybrid CR group versus 61.46% (1201 of 1954 sessions) in the standard CR group). CONCLUSIONS AND RELEVANCE: The results suggest that a hybrid CR program is noninferior to standard center-based CR in a low-resource setting, primarily in terms of recurrent cardiovascular events and potentially in terms of intermediate outcomes. Hybrid CR may induce superior adherence to supervised exercise. Clinical factors and patient preferences should inform CR model allocation. TRIAL REGISTRATION: Identifier: NCT03881150.

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