Clinical trial NCT05868343: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Cardiac Rehabilitation
Hybrid
Randomized controlled trial
Physical Activity
Long term
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 278
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in level of Physical Activity
timeFrame: Questionnaire will be completed at 0 months, 3 months and 9 months
Secondary outcomes:
measure: Change in health-Related Quality of Life
timeFrame: Questionnaire will be completed at 0 months, 3 months and 9 months
measure: Change in functional Capacity
timeFrame: Questionnaire will be completed at 0 months, 3 months and 9 months
measure: Change in anxiety and Depression
timeFrame: Questionnaire will be completed at 0 months, 3 months and 9 months
Other outcomes:
Locations:
city: Bathurst
country: Canada
facility: Hôpital régional Chaleur
state: New Brunswick
city: Bouctouche
country: Canada
facility: Centre J.K. Irving
state: New Brunswick
city: Campbellton
country: Canada
facility: Hôpital Régional de Campbellton
state: New Brunswick
city: Caraquet
country: Canada
facility: Hôpital de l'Enfant-Jésus RHSJ
state: New Brunswick
city: Edmundston
country: Canada
facility: Hôpital régional d'Edmundston
state: New Brunswick
city: Grand Falls
country: Canada
facility: Hôpital général de Grand-Sault
state: New Brunswick
city: Moncton
country: Canada
facility: Coeur en santé
state: New Brunswick
city: Saint-Quentin
country: Canada
facility: Hôtel-Dieu Saint-Joseph de Saint-Quentin
state: New Brunswick
city: Tracadie
country: Canada
facility: Hôpital de Tracadie
state: New Brunswick
Study officials:
affiliation: Université de Sherbrooke
name: Pamela Tanguay
role: PRINCIPAL_INVESTIGATOR
References: