Clinical trial NCT02957955: Cardiovascular Prehabilitation in Patients Awaiting Heart Transplantation (PREHAB HTx Study)
Official title: Cardiovascular Prehabilitation in Patients Awaiting Heart Transplantation - Addressing Clinical Needs (PREHAB HTx Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Heart failure
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
First posted: 2016-11-08
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in functional capacity
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Change in aerobic power
timeFrame: Baseline to 12 weeks
measure: Change in frailty
timeFrame: Baseline to 12 weeks
measure: Change in general quality of life
timeFrame: Baseline to 12 weeks
measure: Change in disease-specific quality of life
timeFrame: Baseline to 12 weeks
measure: Change in depressive symptoms
timeFrame: Baseline to 12 weeks
measure: Change in anxiety
timeFrame: Baseline to 12 weeks
measure: Change in cognitive function
timeFrame: Baseline to 12 weeks
measure: Change in response to a specific traumatic event
timeFrame: Baseline to 12 weeks
measure: Short term post-heart transplantation outcomes
timeFrame: One year post-heart transplantation
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: Ottawa Heart Institute Research Corporation
name: Jennifer Reed, Ph.D, R.Kin
role: PRINCIPAL_INVESTIGATOR
References: