Effectiveness of a Hybrid Cardiac Rehabilitation Program
Primary Purpose
Cardiovascular Diseases
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Center-based Cardiac Rehabilitation Intervention
Hybrid Cardiac Rehabilitation Intervention
Sponsored by

About this trial
This is an interventional treatment trial for Cardiovascular Diseases focused on measuring Cardiac Rehabilitation, Hybrid, Randomized controlled trial, Physical Activity, Long term
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.
Sites / Locations
- Hôpital régional ChaleurRecruiting
- Centre J.K. IrvingRecruiting
- Hôpital Régional de CampbelltonRecruiting
- Hôpital de l'Enfant-Jésus RHSJRecruiting
- Hôpital régional d'EdmundstonRecruiting
- Hôpital général de Grand-SaultRecruiting
- Coeur en santéRecruiting
- Hôtel-Dieu Saint-Joseph de Saint-QuentinRecruiting
- Hôpital de TracadieRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Center-based cardiac rehabilitation program
Hybrid cardiac rehabilitation program
Arm Description
Outcomes
Primary Outcome Measures
Change in level of Physical Activity
Description: The Level of Physical Activity will be collected using the International Physical Activity Questionnaire (IPAQ).
Secondary Outcome Measures
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).
Change in functional Capacity
The Functional Capacity will be evaluated using the six-minute walk test (6MWT).
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05868343
Brief Title
Effectiveness of a Hybrid Cardiac Rehabilitation Program
Official Title
Pragmatic Randomized Controlled Trial to Promote Physical Activity Through Home Exercise After Cardiac Rehabilitation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Sherbrooke
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases
Keywords
Cardiac Rehabilitation, Hybrid, Randomized controlled trial, Physical Activity, Long term
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
First, the centers are randomized to begin the trial period by offering all their patients either hybrid CR or traditional CR. After recruiting half of the target patient population to be included in the study, centers will switch to offering the other type of CR to their new patients admitted from that point on.
Masking
Investigator
Allocation
Randomized
Enrollment
278 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Center-based cardiac rehabilitation program
Arm Type
Active Comparator
Arm Title
Hybrid cardiac rehabilitation program
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Center-based Cardiac Rehabilitation Intervention
Intervention Description
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
Intervention Name(s)
Hybrid Cardiac Rehabilitation Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in level of Physical Activity
Description
Description: The Level of Physical Activity will be collected using the International Physical Activity Questionnaire (IPAQ).
Time Frame
Questionnaire will be completed at 0 months, 3 months and 9 months
Secondary Outcome Measure Information:
Title
Change in health-Related Quality of Life
Description
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).
Time Frame
Questionnaire will be completed at 0 months, 3 months and 9 months
Title
Change in functional Capacity
Description
The Functional Capacity will be evaluated using the six-minute walk test (6MWT).
Time Frame
Questionnaire will be completed at 0 months, 3 months and 9 months
Title
Change in anxiety and Depression
Description
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.
Time Frame
Questionnaire will be completed at 0 months, 3 months and 9 months
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pamela Tanguay
Phone
506-858-4000
Ext
2221
Email
Pamela.Tanguay@usherbrooke.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Mathieu Bélanger
Email
Mathieu.f.belanger@usherbrooke.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela Tanguay
Organizational Affiliation
Université de Sherbrooke
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital régional Chaleur
City
Bathurst
State/Province
New Brunswick
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela Tanguay
Facility Name
Centre J.K. Irving
City
Bouctouche
State/Province
New Brunswick
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela Tanguay
Facility Name
Hôpital Régional de Campbellton
City
Campbellton
State/Province
New Brunswick
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela Tanguay
Facility Name
Hôpital de l'Enfant-Jésus RHSJ
City
Caraquet
State/Province
New Brunswick
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela Tanguay
Facility Name
Hôpital régional d'Edmundston
City
Edmundston
State/Province
New Brunswick
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela Tanguay
Facility Name
Hôpital général de Grand-Sault
City
Grand Falls
State/Province
New Brunswick
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela Tanguay
Facility Name
Coeur en santé
City
Moncton
State/Province
New Brunswick
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela Tanguay
Facility Name
Hôtel-Dieu Saint-Joseph de Saint-Quentin
City
Saint-Quentin
State/Province
New Brunswick
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela Tanguay
Facility Name
Hôpital de Tracadie
City
Tracadie
State/Province
New Brunswick
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela Tanguay
12. IPD Sharing Statement
Plan to Share IPD
No
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Effectiveness of a Hybrid Cardiac Rehabilitation Program
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