Effectiveness of a Hybrid Cardiac Rehabilitation Program

Study Overview
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Brief Summary
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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.

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

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Other: Center-based Cardiac Rehabilitation Intervention
* Other: Hybrid Cardiac Rehabilitation Intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Center-based cardiac rehabilitation program<br> | Other: Center-based Cardiac Rehabilitation Intervention<br>* 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.<br>|
| Experimental: Hybrid cardiac rehabilitation program<br> | Other: Hybrid Cardiac Rehabilitation Intervention<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Rehabilitation, Hybrid, Randomized controlled trial, Physical Activity, Long term