Hybrid Cardiac Rehabilitation Program in a Low-Resource Setting
Authors: Seron Pamela , Oliveros Maria Jose , Marzuca-Nassr Gabriel Nasri , Morales Gladys , Román Claudia , Muñoz Sergio Raúl , Gálvez Manuel , Latin Gonzalo , Marileo Tania , Molina Juan Pablo , Navarro Rocío , Sepúlveda Pablo , Lanas Fernando , Saavedra Nicolás , Ulloa Constanza , Grace Sherry L. ,   HYCARET Investigators, Gomez Daniela , Arancibia María José , Stavros Irene , Muñoz Francisca , Arias Yilia , Ferrada Olga , González Camila , Verdejo Hanier , Segovia María José , Adaros Karen , Aburto Camila , Buzeta Fernando , Valencia Evelyn , Ramos José Tomás , Osorio Marcela , Díaz Fernanda , Aravena Sylvia , Gatta Silvia , Figueroa Juan Luis , Hermosilla Daniela , Díaz Iris , Maldonado Natalia , Navarro-Rañinao Rocío , Olea Verónica , Aravena Ricardo , Sánchez Paulina , Morales Kony , Saldias Marilia , Contreras María Francisca 
Published: January 2024

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