Hybrid Cardiac Rehabilitation Program in a Low-Resource Setting

Author:

Seron Pamela12,Oliveros Maria Jose12,Marzuca-Nassr Gabriel Nasri1,Morales Gladys3,Román Claudia4,Muñoz Sergio Raúl3,Gálvez Manuel5,Latin Gonzalo6,Marileo Tania7,Molina Juan Pablo8,Navarro Rocío9,Sepúlveda Pablo1,Lanas Fernando102,Saavedra Nicolás11,Ulloa Constanza1,Grace Sherry L.12, ,Gomez Daniela13,Arancibia María José13,Stavros Irene13,Muñoz Francisca13,Arias Yilia13,Ferrada Olga13,González Camila13,Verdejo Hanier13,Segovia María José13,Adaros Karen13,Aburto Camila13,Buzeta Fernando13,Valencia Evelyn13,Ramos José Tomás13,Osorio Marcela13,Díaz Fernanda13,Aravena Sylvia13,Gatta Silvia13,Figueroa Juan Luis13,Hermosilla Daniela13,Díaz Iris13,Maldonado Natalia13,Navarro-Rañinao Rocío13,Olea Verónica13,Aravena Ricardo13,Sánchez Paulina13,Morales Kony13,Saldias Marilia13,Contreras María Francisca13

Affiliation:

1. Facultad de Medicina, Departamento de Ciencias de la Rehabilitación, Universidad de La Frontera, Temuco, Chile

2. Centro de Excelencia CIGES, Universidad de La Frontera, Temuco, Chile

3. Facultad de Medicina, Departamento de Salud Pública, Universidad de La Frontera, Temuco, Chile

4. Facultad de Medicina, Escuela de Kinesiología, Pontificia Universidad Católica de Chile, Santiago, Chile

5. Unidad de Kinesiología, Complejo Hospitalario San José, Santiago, Chile

6. Servicio de Medicina Física y Rehabilitación, Hospital Clínico, Hospital San Borja Arriarán, Santiago, Chile

7. Unidad de Rehabilitación Cardiaca, Hospital Regional de Antofagasta, Antofagasta, Chile

8. Servicio de Medicina Física y Rehabilitación, Hospital San Juan de Dios, Santiago, Chile

9. Servicio de Medicina Física y Rehabilitación, Hospital Clínico Universidad de Chile, Santiago, Chile

10. Facultad de Medicina, Departamento de Medicina Interna, Universidad de La Frontera, Temuco, Chile

11. Facultad de Medicina, Departamento de Ciencias Básicas, Universidad de La Frontera, Temuco, Chile

12. York University & University Health Network, University of Toronto, Toronto, Ontario, Canada

13. for the HYCARET Investigators

Abstract

ImportanceWhile effective, cardiovascular rehabilitation (CR) as traditionally delivered is not well implemented in lower-resource settings.ObjectiveTo test the noninferiority of hybrid CR compared with traditional CR in terms of cardiovascular events.Design, Setting, and ParticipantsThis 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.InterventionsParticipants 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 MeasuresThe 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.ResultsA 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 RelevanceThe 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 RegistrationClinicalTrials.gov Identifier: NCT03881150

Publisher

American Medical Association (AMA)

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