Hybrid Cardiac Rehabilitation Program in a Low-Resource Setting: A Randomized Clinical Trial
Pamela Seron1,2, Maria Jose Oliveros1,2, Gabriel Nasri Marzuca-Nassr1
1Facultad de Medicina, Departamento de Ciencias de la Rehabilitación, Universidad de La Frontera, Temuco, Chile.
Insights
Hybrid cardiovascular rehabilitation (CR) is noninferior to standard CR for preventing cardiovascular events in lower-resource settings. This hybrid model may improve adherence to supervised exercise, offering a viable alternative for broader implementation.
Area of Science:
- Cardiology
- Rehabilitation Medicine
- Public Health
Background:
- Traditional cardiovascular rehabilitation (CR) faces implementation challenges in lower-resource settings.
- Effective CR is crucial for managing cardiovascular events and improving patient outcomes.
Purpose of the Study:
- To evaluate the noninferiority of a hybrid CR model compared to traditional CR regarding cardiovascular events.
- To assess secondary outcomes including quality of life, return to work, lifestyle behaviors, and adherence.
Main Methods:
- A pragmatic, multicenter, randomized clinical trial (HYCARET) involving adults post-cardiovascular event.
- Participants received either 10 center-based sessions with remote support (hybrid CR) or 18-22 center-based sessions (standard CR).
- Primary outcome was cardiovascular events or mortality, with follow-up for 1 year.
Main Results:
- Hybrid CR demonstrated noninferiority to standard CR, with fewer cardiovascular events in the hybrid group (5.38% vs. 9.18%).
- No significant differences were observed in most secondary outcomes, except for superior adherence to supervised exercise sessions in the hybrid CR group.
- Per-protocol analyses indicated that noninferiority was maintained across different adherence levels.
Conclusions:
- Hybrid CR is a noninferior alternative to standard CR in low-resource settings, particularly for preventing recurrent cardiovascular events.
- The hybrid model shows potential for superior adherence to supervised exercise.
- Allocation to CR models should consider clinical factors and patient preferences.
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, 0.20-1.68) 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 vs 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:
ClinicalTrials.gov Identifier: NCT03881150.
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