Hybrid Cardiac Rehabilitation Trial (HYCARET)

Universidad de La Frontera

Status: Completed

Conditions: Coronary Artery Disease; Acute Coronary Syndrome

Treatments: Other: Exercise sessions in hybrid program; Other: Transition to unsupervised phase; Other: Group education; Other: Comprehensive assessment; Other: Counseling; Other: Exercise sessions in standard program

Study type: Interventional

Funder types: Other

Identifiers

NCT03881150

Fondecyt 1181734

Details and patient eligibility

About

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.

Full 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.

Enrollment: 186 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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186 participants in 2 patient groups

Hybrid Cardiac Rehabilitation

Experimental group

Description:

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.

Treatment:

Other: Counseling

Other: Exercise sessions in hybrid program

Other: Comprehensive assessment

Other: Transition to unsupervised phase

Standard Cardiac Rehabilitation

Active Comparator group

Description:

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).

Treatment:

Other: Comprehensive assessment

Other: Group education

Other: Exercise sessions in standard program