NCT03881150

Hybrid Cardiac Rehabilitation Trial

Effectiveness of a Hybrid Cardiac Rehabilitation Program for Coronary Artery Disease Patients. Randomized, Multicenter, Non-inferiority Clinical Trial in a Low-resource Setting. HYCARET Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 186 (actual)
• Sponsor: Universidad de La Frontera · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2019-05-06
• Primary completion: 2021-04-05
• Completion: 2022-05-30
• First posted: 2019-03-19
• Last updated: 2023-05-10

Locations

6 sites across 1 country: Chile