Cardiovascular DiseasesNCT05868343
Effectiveness of a Hybrid Cardiac Rehabilitation Program
A study testing Center-based Cardiac Rehabilitation Intervention and Hybrid Cardiac Rehabilitation Intervention in people with Cardiovascular Diseases, run by Université de Sherbrooke at 9 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Center-based Cardiac Rehabilitation Intervention and Hybrid Cardiac Rehabilitation Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 9 sitesCanada
- Study dates
- 1 May 2023to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be and adult (over 19 years old)
- Be eligible for Vitalité Health Network Cardiac rehabilitation program.
Who cannot join
- Have a physical or cognitive condition that precludes participation in an exercise program.
- Have previously participated in a CR program.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Canada9 sites
Hôpital régional Chaleur
Bathurst, New Brunswick
Centre J.K. Irving
Bouctouche, New Brunswick
Hôpital Régional de Campbellton
Campbellton, New Brunswick
Hôpital de l'Enfant-Jésus RHSJ
Caraquet, New Brunswick
Hôpital régional d'Edmundston
Edmundston, New Brunswick
Hôpital général de Grand-Sault
Grand Falls, New Brunswick
Coeur en santé
Moncton, New Brunswick
Hôtel-Dieu Saint-Joseph de Saint-Quentin
Saint-Quentin, New Brunswick
Hôpital de Tracadie
Tracadie, New Brunswick
About this study
Official title: 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.
- Conditions
- Cardiovascular Diseases
- Being tested
- Center-based Cardiac Rehabilitation Intervention, Hybrid Cardiac Rehabilitation Intervention
- Keywords
- Cardiac Rehabilitation, Hybrid, Randomized controlled trial, Physical Activity, Long term
- Medical subject headings
- Cardiovascular Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Center-based Cardiac Rehabilitation InterventionOther
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 InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Center-based cardiac rehabilitation program | Active comparator | Not described Receives: Other: Center-based Cardiac Rehabilitation Intervention |
| Hybrid cardiac rehabilitation program | Experimental | Not described Receives: Other: Hybrid Cardiac Rehabilitation Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in level of Physical Activity
Description: The Level of Physical Activity will be collected using the International Physical Activity Questionnaire (IPAQ).
Measured: Questionnaire will be completed at 0 months, 3 months and 9 months
Secondary outcomes (3)
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).
Measured: 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).
Measured: 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.
Measured: Questionnaire will be completed at 0 months, 3 months and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start1 May 2023
- Primary completion30 Nov 2024
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Investigator
- Enrolment
- 278 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pamela Tanguay, Université de Sherbrooke
- Investigators
- Pamela Tanguay, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05868343
- Sponsor's protocol ID
- 101745
- Status last verified
- Jan 2025
- First submitted
- 4 Apr 2023
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Randomized Controlled Trial to Promote Physical Activity Through Home Exercise After Cardiac Rehabilitation
- ClinicalTrials.gov ID
- NCT05868343
- Acronym / sponsor ID
- 101745
- Conditions
- Cardiovascular Diseases
- Keywords
- Cardiac Rehabilitation, Hybrid, Randomized controlled trial, Physical Activity, Long term
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 278 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Center-based cardiac rehabilitation program | Active comparator | Other: Center-based Cardiac Rehabilitation Intervention |
| Hybrid cardiac rehabilitation program | Experimental | Other: Hybrid Cardiac Rehabilitation Intervention |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Be and adult (over 19 years old)
- Be eligible for Vitalité Health Network Cardiac rehabilitation program.
Key exclusion criteria (2 listed)
- Have a physical or cognitive condition that precludes participation in an exercise program.
- Have previously participated in a CR program.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Center-based Cardiac Rehabilitation InterventionThe 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. | Other | Center-based cardiac rehabilitation program |
| Hybrid Cardiac Rehabilitation InterventionThe 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. | Other | Hybrid cardiac rehabilitation program |
Primary outcome
Change in level of Physical Activity
Time frame: Questionnaire will be completed at 0 months, 3 months and 9 months
Description: The Level of Physical Activity will be collected using the International Physical Activity Questionnaire (IPAQ).
3 secondary outcomes
Change in health-Related Quality of Life
Time frame: Questionnaire will be completed at 0 months, 3 months and 9 months
Change in functional Capacity
Time frame: Questionnaire will be completed at 0 months, 3 months and 9 months
Change in anxiety and Depression
Time frame: Questionnaire will be completed at 0 months, 3 months and 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pamela Tanguay principal investigator
Université de Sherbrooke
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Center-based Cardiac Rehabilitation Intervention and Hybrid Cardiac Rehabilitation Intervention in people with Cardiovascular Diseases, run by Université de Sherbrooke at 9 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in level of Physical Activity (time frame: Questionnaire will be completed at 0 months, 3 months and 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.