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OpenTrials
Active, Not Recruiting

NCT Number: NCT05868343

Effectiveness of a Hybrid Cardiac Rehabilitation Program

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cardiovascular Diseases Behavior Motor Activity

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital régional Chaleur, Bathurst, New Brunswick, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Center-based Cardiac Rehabilitation Intervention

Other

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 Intervention

Other

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 outcomes

  1. 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).

Secondary outcomes

  1. Change in health-Related Quality of Life

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

    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).

  2. Change in functional Capacity

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

    The Functional Capacity will be evaluated using the six-minute walk test (6MWT).

  3. Change in anxiety and Depression

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

    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.

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
May 22, 2023
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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