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Active, not recruitingNCT05868343Updated Jan 14, 2025

Effectiveness of a Hybrid Cardiac Rehabilitation Program

An interventional study of Center-based Cardiac Rehabilitation Intervention and Hybrid Cardiac Rehabilitation Intervention in Cardiovascular Diseases, sponsored by Université de Sherbrooke. Active, not recruiting at 9 sites in Canada. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-01-14.

Sponsored by Université de Sherbrooke · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
278
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Cardiovascular Diseases

Keywords

  • Cardiac Rehabilitation
  • Hybrid
  • Randomized controlled trial
  • Physical Activity
  • Long term
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In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's planned enrollment of 278 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Université de Sherbrooke is the lead sponsor of 289 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Be and adult (over 19 years old)
  • Be eligible for Vitalité Health Network Cardiac rehabilitation program.

Exclusion criteria

Exclusion Criteria:

  • Have a physical or cognitive condition that precludes participation in an exercise program.
  • Have previously participated in a CR program.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Investigator)
Enrollment
278 participants (estimated)

Study arms

  • Active comparator
    Center-based cardiac rehabilitation program

    Other: Center-based Cardiac Rehabilitation Intervention

  • Experimental
    Hybrid cardiac rehabilitation program

    Other: Hybrid Cardiac Rehabilitation Intervention

Interventions

  • OtherCenter-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.

  • OtherHybrid 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.

06

What researchers measure

Primary outcomes

  1. Change in level of Physical Activity

    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 outcomes

  1. 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).

    Time frame: Questionnaire will be completed at 0 months, 3 months and 9 months

  2. Change in functional Capacity

    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

  3. 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.

    Time frame: Questionnaire will be completed at 0 months, 3 months and 9 months

07

Study locations

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

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05868343
Lead sponsor
Université de Sherbrooke
Responsible party
Pamela Tanguay (Principal Investigator, Université de Sherbrooke) — Principal investigator
First posted
May 22, 2023
Start date
May 1, 2023
Primary completion
Nov 30, 2024
Completion
Aug 31, 2025 (estimated)
Last update
Jan 14, 2025

Study contacts

Pamela Tanguay
principal investigator · Université de Sherbrooke

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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