Effectiveness of a Hybrid Cardiac Rehabilitation Program

NCT ID: NCT05868343

Last Updated: 2025-01-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 278 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2025-08-31

Brief Summary

The goal of this pragmatic randomized clinical trial is to compare the effectiveness of a hybrid model of cardiac rehabilitation with a centre-based program in people with cardiovascular disease. The main question it aims to answer is:

• How effective is a hybrid model of CR for people with cardiovascular disease living in a francophone minority community compared to a centre-based model of CR in terms of leading to maintenance of gains (physical activity level, functional capacity, mental health, quality of life) six months after CR? Participants will undergo a 12-week hybrid cardiac rehabilitation program. For the first six weeks, patients will be required to attend the hospital twice a week. After that, there will be a gradual increase in home sessions for the remaining six weeks. When a patient has a home session, health professionals will follow up with a weekly phone call.

Researchers will compare the centre-based cardiac rehabilitation program with the hybrid program to see if the hybrid program can better maintain the level of physical activity, mental health, functional capacity, and quality of life six months after the end of the program.

Conditions

Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Center-based cardiac rehabilitation program

Group Type: ACTIVE_COMPARATOR

Center-based Cardiac Rehabilitation Intervention

Intervention Type: OTHER

The center-based cardiac rehabilitation program is 12 weeks in length. Participants will travel to the center twice a week for the duration of the program. Participants receive an individualized exercise program to be completed at the center according to Canadian recommendations. Twelve pre-recorded educational vignettes on various health topics and two group educational sessions on nutrition are offered to participants in person during the first twelve sessions at the center. In addition, at the beginning of the CR program, participants watch a motivational vignette from one of our patient partners about the importance and benefits of following the CR program. Depending on the needs of each participant, they may be referred to various external clinics within the Vitalité network, such as the Nutrition Service.

Hybrid cardiac rehabilitation program

Group Type: EXPERIMENTAL

Hybrid Cardiac Rehabilitation Intervention

Intervention Type: OTHER

The center-based cardiac rehabilitation program is 12 weeks in length. For the first six weeks, participants are required to attend the hospital twice a week. After that, there will be a gradual increase in home sessions for the remaining six weeks. When a patient has a home session, health professionals follow up with a phone call.Twelve pre-recorded educational vignettes on various health topics and two group educational sessions on nutrition are offered to participants in person during the first twelve sessions at the center. In addition, at the beginning of the CR program, participants watch a motivational vignette from one of our patient partners about the importance and benefits of following the CR program. Depending on the needs of each participant, they may be referred to various external clinics within the Vitalité network, such as the Nutrition Service.

Interventions

Center-based Cardiac Rehabilitation Intervention

The center-based cardiac rehabilitation program is 12 weeks in length. Participants will travel to the center twice a week for the duration of the program. Participants receive an individualized exercise program to be completed at the center according to Canadian recommendations. Twelve pre-recorded educational vignettes on various health topics and two group educational sessions on nutrition are offered to participants in person during the first twelve sessions at the center. In addition, at the beginning of the CR program, participants watch a motivational vignette from one of our patient partners about the importance and benefits of following the CR program. Depending on the needs of each participant, they may be referred to various external clinics within the Vitalité network, such as the Nutrition Service.

Intervention Type: OTHER

Hybrid Cardiac Rehabilitation Intervention

The center-based cardiac rehabilitation program is 12 weeks in length. For the first six weeks, participants are required to attend the hospital twice a week. After that, there will be a gradual increase in home sessions for the remaining six weeks. When a patient has a home session, health professionals follow up with a phone call.Twelve pre-recorded educational vignettes on various health topics and two group educational sessions on nutrition are offered to participants in person during the first twelve sessions at the center. In addition, at the beginning of the CR program, participants watch a motivational vignette from one of our patient partners about the importance and benefits of following the CR program. Depending on the needs of each participant, they may be referred to various external clinics within the Vitalité network, such as the Nutrition Service.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Be and adult (over 19 years old)
• Be eligible for Vitalité Health Network Cardiac rehabilitation program.

Exclusion Criteria

• Have a physical or cognitive condition that precludes participation in an exercise program.
• Have previously participated in a CR program.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Université de Sherbrooke

OTHER

Sponsor Role: lead

Responsible Party

Pamela Tanguay

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pamela Tanguay

Role: PRINCIPAL_INVESTIGATOR

Université de Sherbrooke

Locations

Hôpital régional Chaleur

Bathurst, New Brunswick, Canada

Centre J.K. Irving

Bouctouche, New Brunswick, Canada

Hôpital Régional de Campbellton

Campbellton, New Brunswick, Canada

Hôpital de l'Enfant-Jésus RHSJ

Caraquet, New Brunswick, Canada

Hôpital régional d'Edmundston

Edmundston, New Brunswick, Canada

Hôpital général de Grand-Sault

Grand Falls, New Brunswick, Canada

Coeur en santé

Moncton, New Brunswick, Canada

Hôtel-Dieu Saint-Joseph de Saint-Quentin

Saint-Quentin, New Brunswick, Canada

Hôpital de Tracadie

Tracadie, New Brunswick, Canada

Countries

Canada

Other Identifiers

101745

Identifier Type: -

Identifier Source: org_study_id