Hybrid Cardiac Rehabilitation Trial

NCT ID: NCT03881150

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 186 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-06
• Study Completion Date: 2022-05-30

Brief Summary

This clinical trial aim to evaluate if the prevention of recurrent cardiovascular events is not inferior in the hybrid mobile and exercise-based cardiac rehabilitation programs in comparison to the standard cardiac rehabilitation program.

Detailed Description

Background: Cardiac rehabilitation (CR) programs are well established, as their effectiveness and cost-effectiveness is proven. In spite of this, CR remains under-utilized, especially in middle and low-resource settings such as Latin America. As the highest rates of mortality and disability-adjusted life-years in the world are caused by cardiovascular diseases, with a corresponding major impact on economies, there is an urgent need to create more accessible CR delivery models to reach all patients in need. This trial aims to evaluate if the prevention of recurrent cardiovascular events is not inferior in a hybrid cardiac rehabilitation program compared to a standard program.

Method and analysis: A non-inferiority, pragmatic, multicenter, parallel (1:1), single blinded, randomized clinical trial will be conducted. 314 patients with coronary artery disease will be recruited consecutively. Participants will be randomized to hybrid or standard rehabilitation programs. The hybrid CR program includes 10 supervised exercise sessions and individualized lifestyle counseling by a physiotherapist, with a transition after 4-6 weeks to unsupervised delivery via text messages and phone calls. The standard CR consists of 18-22 supervised exercise sessions, as well as group education sessions about lifestyle. The intervention in both groups will be by 12 weeks. The primary outcome is a composite of cardiovascular mortality and hospitalizations due to cardiovascular causes. Secondary outcomes are cardiovascular risk factor control, exercise capacity, adherence to physical activity and diet recommendations, health-related quality of life and exercise-related adverse events. The outcomes will be measured at the end of intervention, at 6 months, and at 12-month follow-up from recruitment. The primary outcome will be tracked through the end of the trial. The sample size was calculated considering 5% of the non-inferiority limit. Per protocol and intention-to-treat analysis will be undertaken. A survival analysis will be run for the primary outcome.

Ethics and dissemination: The corresponding ethical committees at the sponsor institution and each center where participants will be recruited approved the study protocol and the Informed Consent form. Research findings will be published in peer-reviewed journals. Additionally, scientific results will be disseminated among stakeholders and national policy-makers.

Conditions

Coronary Artery Disease; Acute Coronary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Hybrid Cardiac Rehabilitation

This intervention is adapted from the "Cardiac Rehabilitation Delivery Model for Low-Resource Settings" proposed by the International Council of Cardiovascular Prevention and Rehabilitation Consensus Statement. This program will be delivered by an exercise specialist (physiotherapist) and the principal purposes of the exercise sessions is to develop patient self-management related to the physical activity habit, and educate them how to monitor exercise intensity at home and in daily life. The program include 10 face-to-face exercise sessions and a transition to unsupervised phase using mobile technology.

Counseling is considered about physical activity, diet, smoking, and medication compliance.

Group Type: EXPERIMENTAL

Comprehensive assessment

Intervention Type: OTHER

Includes evaluation about physical activity, diet, tobacco consumption, overweight/obesity, blood pressure, self-efficacy, and medications. Additionally, levels of lipids and glycaemia will be reviewed from clinical chart.

Counseling

Intervention Type: OTHER

Physical activity, diet, smoking, and medication compliance counseling will be provided by the physiotherapist across exercise sessions, using a self-efficacy approach. A booklet was designed in order to support the individual counseling.

Exercise sessions in hybrid program

Intervention Type: OTHER

10 supervised exercise sessions over 4-6 weeks of aerobic and resistance training will ensue, supervised by a physiotherapist. Exercise sessions are 10 minutes in duration at the beginning of the program, and are progressed to 60 minutes by the end as tolerated.

Intensity of exercise will be moderate.

Transition to unsupervised phase

Intervention Type: OTHER

After 4-6 weeks with face-to-face exercise sessions in hybrid program, all patients will be monitored through mobile technology. Delivery methods will include voice calls biweekly, and text messaging three per week through to 10-12 weeks from program initiation. The content will promote physical activity, healthy diet, and medication adherence.

Standard Cardiac Rehabilitation

The participants in the control group will receive the standard cardiac rehabilitation that is delivered in participating centers. These programs accounts with physicians, nurses, nutritionists and physiotherapists. The programs will be standardized in participating centers in accordance with currents guidelines (only 18-22 face-to-face exercise sessions). Differentially, this programs provide, group education sessions about physical activity, diet, smoking, and medication compliance (without counseling).

Group Type: ACTIVE_COMPARATOR

Comprehensive assessment

Intervention Type: OTHER

Includes evaluation about physical activity, diet, tobacco consumption, overweight/obesity, blood pressure, self-efficacy, and medications. Additionally, levels of lipids and glycaemia will be reviewed from clinical chart.

Group education

Intervention Type: OTHER

Group education sessions about physical activity, diet, smoking, and medication compliance (without individual counseling), as actually performed in each center.

Exercise sessions in standard program

Intervention Type: OTHER

18-22 supervised exercise sessions are delivered over the 8-12 week program. These sessions include aerobic and resistance training and a similar progression of duration as the experimental group.

Intensity of exercise will be moderate.

Interventions

Comprehensive assessment

Includes evaluation about physical activity, diet, tobacco consumption, overweight/obesity, blood pressure, self-efficacy, and medications. Additionally, levels of lipids and glycaemia will be reviewed from clinical chart.

Intervention Type: OTHER

Counseling

Physical activity, diet, smoking, and medication compliance counseling will be provided by the physiotherapist across exercise sessions, using a self-efficacy approach. A booklet was designed in order to support the individual counseling.

Intervention Type: OTHER

Group education

Group education sessions about physical activity, diet, smoking, and medication compliance (without individual counseling), as actually performed in each center.

Intervention Type: OTHER

Exercise sessions in hybrid program

10 supervised exercise sessions over 4-6 weeks of aerobic and resistance training will ensue, supervised by a physiotherapist. Exercise sessions are 10 minutes in duration at the beginning of the program, and are progressed to 60 minutes by the end as tolerated.

Intensity of exercise will be moderate.

Intervention Type: OTHER

Exercise sessions in standard program

18-22 supervised exercise sessions are delivered over the 8-12 week program. These sessions include aerobic and resistance training and a similar progression of duration as the experimental group.

Intensity of exercise will be moderate.

Intervention Type: OTHER

Transition to unsupervised phase

After 4-6 weeks with face-to-face exercise sessions in hybrid program, all patients will be monitored through mobile technology. Delivery methods will include voice calls biweekly, and text messaging three per week through to 10-12 weeks from program initiation. The content will promote physical activity, healthy diet, and medication adherence.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age 18 year old or over.
• Patient with coronary artery disease, including Acute Coronary Syndrome (Unstable Angina, Myocardial infarction with or without ST elevation) or stable coronary vessel disease diagnosed by angiography or a stress test.
• Patient treated medically (i.e., medication only) or by thrombolysis, angioplasty, or revascularization surgery.
• Patient with physician referral, that can start CR between 2 weeks and 2 months from their event, diagnosis or procedure.
• Patient able to attend the health center almost twice a week over three months.
• Patient owns a mobile phone.
• Patient that consents to participate in the study through signing an informed consent form.

Exclusion Criteria

• Patient has a planned repeat cardiac or other procedure in next 12 months.
• Explicit contraindication to perform exercise based on American College of Sport Medicine.
• Patients with comorbidities that would interfere with ability to engage in cardiac rehabilitation such as dementia, blindness, deafness, serious mental illness, or frailty.
• Musculoskeletal disease that precludes the patient from performing exercise

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad de La Frontera

OTHER

Sponsor Role: lead

Responsible Party

Pamela Serón

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pamela J Seron, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad de La Frontera

Locations

Universidad de La Frontera

Temuco, Región de la Araucanía, Chile

Hospital Regional de Antofagasta

Antofagasta, , Chile

Complejo Hospitalario San José

Santiago, , Chile

Hospital Clínico Universidad de Chile

Santiago, , Chile

Hospital San Borja Arriarán

Santiago, , Chile

Hospital San Juan de Dios

Santiago, , Chile

Countries

Chile

References

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; HYCARET Investigators. Hybrid Cardiac Rehabilitation Program in a Low-Resource Setting: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jan 2;7(1):e2350301. doi: 10.1001/jamanetworkopen.2023.50301.

Reference Type: DERIVED

PMID: 38194236 (View on PubMed)

Seron P, Oliveros MJ, Marzuca-Nassr GN, Lanas F, Morales G, Roman C, Munoz SR, Saavedra N, Grace SL. Hybrid cardiac rehabilitation trial (HYCARET): protocol of a randomised, multicentre, non-inferiority trial in South America. BMJ Open. 2019 Oct 28;9(10):e031213. doi: 10.1136/bmjopen-2019-031213.

Reference Type: DERIVED

PMID: 31662385 (View on PubMed)

Other Identifiers

Fondecyt 1181734

Identifier Type: -

Identifier Source: org_study_id