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

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Behavioral: High-Intensity Interval Training

• Registration Number: NCT02957955
• Lead Sponsor: Ottawa Heart Institute Research Corporation

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 Timeline

• Study First Submitted: 2016-10-27
• Study First Submitted QC: 2016-11-03
• Study First Posted: 2016-11-08
• Study Start: 2018-05-01
• Primary Completion: 2020-02-02
• Study Completion: 2020-02-02
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-28
• Last Update Posted: 2021-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in functional capacity	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 Outcome Measures

Name	Time	Method
Change in frailty	Baseline to 12 weeks	Measured by the Fried criteria. Measured by presence of 3 out of 5 frailty symptoms.
Change in response to a specific traumatic event	Baseline to 12 weeks	Measured by the Impact of Events Scale- Revised (IES-R). IES-R is 22 items, zero to four scale. Scores above 23 are of concern; scores above 32 indicate a probable diagnosis of PTSD.
Change in aerobic power	Baseline to 12 weeks	Measured using expired VO2 gas samples, measured in L/min, ml/kg/min
Change in general quality of life	Baseline to 12 weeks	Measured by the Short Form 36 Health Survey Questionnaire (SF-36). The SF-36 consists of 8-scaled scores which are the weighted sums of the questions in their section.
Short term post-heart transplantation outcomes	One year post-heart transplantation	Data collected from medical records: length of hospital stay, adverse events (infection, treated rejection, bleeding, and stroke), survival to hospital discharge, and 30 day hospital readmissions.
Change in disease-specific quality of life	Baseline to 12 weeks	Measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ). MLHFQ is a 21-item scale that measures the effects of heart failure on quality of life using a 6-point scale.
Change in cognitive function	Baseline to 12 weeks	Measured by the Montreal Cognitive Assessment (MOCA). The MOCA is made up of 8 subscales, scores are totaled; maximum score is 30 points.
Change in depressive symptoms	Baseline to 12 weeks	Measured by the Beck Depression Inventory II (BDI-II). It contains 21-questions, each answer being scored on a scale of 0 to 3.
Change in anxiety	Baseline to 12 weeks	Measured by the Beck Anxiety Inventory (BAI). The BAI is a 21-item validated self-reported measure. A total score is calculated by summing the items; maximum score is 62.

Trial Locations

Locations (2)

University of Ottawa Heart Institute; 🇨🇦 Ottawa, Ontario, Canada

University Health Network; 🇨🇦 Toronto, Ontario, Canada