Cardiovascular Prehabilitation in Patients Awaiting Heart Transplantation (PREHAB HTx Study)

University of Ottawa Heart Institute

Status: Completed

Conditions: Heart Failure

Treatments: Behavioral: High-Intensity Interval Training

Study type: Interventional

Funder types: Other

Identifiers

NCT02957955

20160753-01H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Advanced heart failure and listed for heart transplantation.
2. Able to perform a symptom-limited exercise test.
3. Age =>18 years old.
4. Able to provide informed consent.

Exclusion criteria

1. Currently participating in a structured exercise training program (> 2 times per week)
2. Status 4 priority listing for heart transplantation.
3. Myocardial infarction =<7 days.
4. Heart failure with hemodynamic instability.
5. Hypertrophic obstructive cardiomyopathy with symptomatic left ventricular outflow tract gradient =>30 mmHg.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6 participants in 2 patient groups

Interventional

Experimental group

Description:

Group 1. Usual care + High-Intensity Interval Training, Nutritional Workshop, Stress Management Course.

Treatment:

Behavioral: High-Intensity Interval Training

Non interventional

No Intervention group

Description:

Group 2. Usual care. Patients are encouraged to remain physically active, although they do not participate in a regular structured exercise training program.