Cardiovascular Prehabilitation in Patients Awaiting Heart Transplantation - Addressing Clinical Needs (PREHAB HTx Study)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 6
- Locations
- 3
- Primary Endpoint
- Change in functional capacity
Study Overview
Brief Summary
This study evaluates the addition of high-intensity interval training to the standard pre-heart transplantation clinical care. Participants will be randomised into 2 arms: one arm will receive high-intensity interval training, and the other arm will be encouraged to remain physically active, although they do not participate in a regular structured exercise training program.
Detailed Description
Heart failure affects more than 6.2 million people living in North America. Approximately 10% of patients with heart failure have advanced heart failure. Heart transplantation is an effective life-saving treatment for patients with advanced heart failure. The cardiovascular rehabilitation programs are integral to heart failure management.
This study is being done to evaluate, in adults with advanced heart failure awaiting heart transplantation, the effects of cardiovascular rehabilitation (including high-intensity interval training, stress management and nutrition workshops) on functional capacity, aerobic power, frailty, quality of life, and mental health.
This study compares pre-transplant cardiovascular rehabilitation with usual pre-transplant care in patients with advanced heart failure awaiting heart transplant.
All participants will be randomized into 2 study groups: Group 1 (rehab), and Group 2 (no rehab). Those randomized to Group 1 will receive usual care, 12 weeks of rehab (exercise training, and attend stress and nutrition course through the Heart Failure Clinic and the Division of Prevention and Rehabilitation at the University of Ottawa Heart Institute). Those randomized to Group 2 will receive regular visits through the Heart Failure Clinic; patients are encouraged to remain physically active, although they do not participate in a regular structured exercise training program.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Advanced heart failure and listed for heart transplantation.
- •Able to perform a symptom-limited exercise test.
- •Age =>18 years old.
- •Able to provide informed consent.
Exclusion Criteria
- •Currently participating in a structured exercise training program (> 2 times per week)
- •Status 4 priority listing for heart transplantation.
- •Myocardial infarction =<7 days.
- •Heart failure with hemodynamic instability.
- •Hypertrophic obstructive cardiomyopathy with symptomatic left ventricular outflow tract gradient =>30 mmHg.
Outcomes
Primary Outcomes
Change in functional capacity
Time Frame: Baseline to 12 weeks
Change in in functional capacity from baseline to 12 weeks as measured by six-minute walk test distance. Distance walked will be measured in meters.
Secondary Outcomes
- Change in frailty(Baseline to 12 weeks)
- Change in response to a specific traumatic event(Baseline to 12 weeks)
- Change in aerobic power(Baseline to 12 weeks)
- Change in general quality of life(Baseline to 12 weeks)
- Short term post-heart transplantation outcomes(One year post-heart transplantation)
- Change in disease-specific quality of life(Baseline to 12 weeks)
- Change in cognitive function(Baseline to 12 weeks)
- Change in depressive symptoms(Baseline to 12 weeks)
- Change in anxiety(Baseline to 12 weeks)