Effectiveness of a Hybrid Cardiac Rehabilitation Program

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Other: Center-based Cardiac Rehabilitation Intervention; Other: Hybrid Cardiac Rehabilitation Intervention

• Study Type: Interventional
• Enrollment (Estimated): 278
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • New Brunswick
    • Bathurst, New Brunswick, Canada
      • Hôpital régional Chaleur
    • Bouctouche, New Brunswick, Canada
      • Centre J.K. Irving
    • Campbellton, New Brunswick, Canada
      • Hôpital Régional de Campbellton
    • Caraquet, New Brunswick, Canada
      • Hôpital de l'Enfant-Jésus RHSJ
    • Edmundston, New Brunswick, Canada
      • Hôpital régional d'Edmundston
    • Grand Falls, New Brunswick, Canada
      • Hôpital général de Grand-Sault
    • Moncton, New Brunswick, Canada
      • Coeur en santé
    • Saint-Quentin, New Brunswick, Canada
      • Hôtel-Dieu Saint-Joseph de Saint-Quentin
    • Tracadie, New Brunswick, Canada
      • Hôpital de Tracadie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Center-based cardiac rehabilitation program	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.
Experimental: Hybrid cardiac rehabilitation program	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Université de Sherbrooke
• Investigators: Principal Investigator: Pamela Tanguay, Universite de Sherbrooke

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): November 30, 2024
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: April 4, 2023
• First Submitted That Met QC Criteria: May 19, 2023
• First Posted (Actual): May 22, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 10, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Physical Activity; Randomized controlled trial; Cardiac Rehabilitation; Hybrid; Long term
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 101745

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No