Effectiveness of a Hybrid Cardiac Rehabilitation Program

Cardiovascular Diseases Clinical Trial

Official title:

Pragmatic Randomized Controlled Trial to Promote Physical Activity Through Home Exercise After Cardiac Rehabilitation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05868343
• Other study ID #: 101745
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: August 31, 2025

Study information

• Verified date: April 2024
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 278
• Est. completion date: August 31, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Canada	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

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in level of Physical Activity	Description: The Level of Physical Activity will be collected using the International Physical Activity Questionnaire (IPAQ).	Questionnaire will be completed at 0 months, 3 months and 9 months
Secondary	Change in health-Related Quality of Life	The Health-Related Quality of life will be collected using the Euro-QoL 5-dimension Questionnaire (EQ-5D-5L). The EQ-5D-5L can be summarized as an index value varying from -0.148 (worst score) to +0.949 (best score).	Questionnaire will be completed at 0 months, 3 months and 9 months
Secondary	Change in functional Capacity	The Functional Capacity will be evaluated using the six-minute walk test (6MWT).	Questionnaire will be completed at 0 months, 3 months and 9 months
Secondary	Change in anxiety and Depression	Anxiety and depression will be collected using the Hospital Anxiety and Depression Scale (HADS). The total score ranges from 0 to 21 for each subscale (anxiety and depression). A higher score indicates a greater risk of having an anxiety or depression disorder.	Questionnaire will be completed at 0 months, 3 months and 9 months