Pilot Randomized Clinical Trial of Live-streamed Cardiovascular Rehabilitation

NCT05157568 | Terminated

• 1 other identifier: 20210752-01H
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiovascular Rehabilitation (CR) programs are designed to help people recover following a heart attack, heart surgery, or diagnosis of heart disease. Counseling, education, risk factor management, and efforts to increase levels of MVPA constitute the largest components of CR programs. Technological advances in video-conferencing and video-streaming are affording new opportunities to increase access to CR services and supervised exercise sessions for patients who are social distancing, or who face access issues (e.g., time, mobility, transportation etc.). Comfort with these technologies for CR staff and patients has been accelerated by the current pandemic. Technology-enabled interactions between patients and providers is a significant opportunity to help mitigate these effects. We developed a new model for delivery of group exercise training for people with heart disease. Our model delivers all the core components of CR (i.e. counseling, education, risk factor management) but also includes live-streaming of CR exercise classes. Two versions of these classes are available: one that does not require any exercise equipment; and one that relies on a stationary exercise bike and exercise band delivered and installed in patients' homes. The new model has performed well in proof-of-concept testing, but now needs to be rigorously evaluated.

Conditions

Cardiac Disease

Keywords

Cardiovascular Rehabilitation; Virtual Rehabilitation

Outcome Measures

Primary Outcomes (4)

• Eligibility

  What proportion of patients referred to CR are eligible to participate based on the inclusion and exclusion criteria?

  8 weeks

• Feasibility of recruitment

  What proportion of eligible patients accept the invitation to participate in the research and agree to be randomized to treatment?

  8 weeks

• Feasibility of equipment delivery

  Are the interventions acceptable in terms of completion of delivery and set-up of home exercise equipment (ES+E group only), scheduled coaching contacts, and exercise training class attendance (ES and ES+E groups)?

  8 weeks

• Retention

  How many patients will complete of follow-up assessments at the end of intervention (8 weeks)?

  8 weeks

Study Arms (3)

Control (C)

ACTIVE COMPARATOR

Participants will receive a exercise prescription and a home exercise plan. It will specify how many days per week they should exercise and will indicate how hard they should be working using their heart rate and rating of perceived exertion (RPE) as a guide. They will attend 8 onsite rehabilitation classes at the University of Ottawa Heart Institute (1 class per week for 8 weeks). These classes will be led by a specially trained instructor who will teach and encourage self-monitoring of heart rate and RPE. The class will include a warm-up, 30 minutes of aerobic exercise and a 15 min cool-down, including strength exercises and stretches. Following each class there will be a short mini-education session highlighting a variety of topics on how to manage risk factors. Patients will have access to onsite classes for nutrition and stress management. Participants will receive access to 8 additional educational videos that highlight topics such as exercise safety, goal setting and nutrition.

Behavioral: Control

Exercise Streaming (ES)

ACTIVE COMPARATOR

Participants will complete 1 "live" virtual class per week for 8-weeks. Classes will be led by a specially trained instructor and will include a warm-up, 30 minutes of aerobic exercise, 10 minutes of strength exercises, and a cooldown and stretching segment. During each live class, the instructor will play the corresponding video and supervise the participants through the Zoom for Healthcare platform. Heart rates and RPE data will be collected from each participant. Participants will have access to other pre-recorded exercise videos that they can stream "on demand" at any time. They will be encouraged to access them "on demand" throughout the week. In addition participants will have access to the same 8 pre-recorded educational videos that the control group will receive. Topics include; exercise safety, goal setting, nutrition, stress management, medication information, risk factor awareness and transition planning.

Behavioral: Exercise Streaming (ES)

Exercise Streaming + Equipment (ES+E)

ACTIVE COMPARATOR

Participants will receive an indoor bicycle and an exercise band (delivered and set up in their home). Participants will complete 1 "live" class per week for 8 weeks. Their exercise prescription will be based on a stress test. Classes will be led by a specially trained instructor and will include a warm-up, 30 minutes of aerobic exercise, 10 minutes of strength exercises, and a cooldown and stretching segment. During each "live" class, the exercise supervisor will play the corresponding video and supervise the participants through the Zoom for Healthcare platform. Heart rate and RPE data will be collected from each participant. Participants will have access to other pre-recorded exercise videos that they can stream "on demand" at any time. Participants will be encouraged to access them throughout the week. Participants will have access to the same 8 pre-recorded educational videos that the control and exercise streaming groups will receive.

Behavioral: Exercise Streaming + Equipment (ES+E)

Interventions

Exercise Streaming (ES) BEHAVIORAL

Participants will complete 8 weeks (1 class per week) of supervised exercise online. No equipment is required. They will follow a pre-recorded exercise video and at the same time, get instruction, feedback and support from their coach. Each class will be held as a teleconference.

Exercise Streaming (ES)

Exercise Streaming + Equipment (ES+E) BEHAVIORAL

Participants will complete 8 weeks (1 class per week) of supervised exercise online. Each participant will have a stationary exercise bike delivered to their home for use during their live classes. They will follow a pre-recorded exercise video and at the same time, get instruction, feedback and support from their coach. Each class will be held as a teleconference.

Exercise Streaming + Equipment (ES+E)

Control BEHAVIORAL

Participants will complete 8 weeks (1 class per week) of in-person supervised exercise.

Control (C)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient was discharged from hospitalized at UOHI within the last 12 weeks;
• Patient has stable CHD or repaired valvular disease;
• Patient has been referred to CR and is a candidate an offsite program;
• Patient is able to completed a cardiopulmonary exercise test;
• Patient has access to and regularly uses a smart phone, tablet or computer with Internet access;
• Patient is ≥ 18 years of age (the age of consent in Ontario);
• Patient is able to provide informed consent

You may not qualify if:

• Patient was hospitalized for heart failure, congenital heart disease, transplant or arrhythmia within the last 6 months;
• Patient, in the opinion of the medical advisor (Dr. Andrew Pipe/Dr. Hassan Mir), manifests illness or disease that would preclude participation in the interventions (e.g. cognitive impairment, active drug or alcohol dependence, unresolved cardiac symptoms).

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (1)

The University of Ottawa Heart Institute

Ottawa, Ontario, K1Y4W7, Canada

Location

MeSH Terms

Conditions

Heart Diseases

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Thais Coutinho, MD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: December 15, 2021
• Study Start: September 20, 2022
• Primary Completion: February 24, 2023
• Study Completion: September 1, 2023
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)