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

April 28, 2021 updated by: Ottawa Heart Institute Research Corporation

Cardiovascular Prehabilitation in Patients Awaiting Heart Transplantation - Addressing Clinical Needs (PREHAB HTx Study)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1Y4W7
        • University of Ottawa Heart Institute
      • Toronto, Ontario, Canada
        • University Health Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional
Group 1. Usual care + High-Intensity Interval Training, Nutritional Workshop, Stress Management Course.
Behavioral: High-Intensity Interval Training
Participants will complete supervised exercise sessions. Participants will attend on-site high-intensity interval training two times weekly for 12 weeks. Participants will complete six-minute walk test, cardiopulmonary exercise test, and six questionnaires: Short Form 36 Health Survey Questionnaire (SF-36), Minnesota Living with Heart Failure Questionnaire (MLHFQ), Beck Depression Inventory II (BDI-II), Beck Anxiety Inventory (BAI), Montreal Cognitive Assessment (MOCA), and Impact of Events Scale-Revised (IES-R) at baseline (week 1) and follow-up (after 12 weeks of intervention).
No Intervention: Non interventional
Group 2. Usual care. Patients are encouraged to remain physically active, although they do not participate in a regular structured exercise training program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in aerobic power
Time Frame: Baseline to 12 weeks
Measured using expired VO2 gas samples, measured in L/min, ml/kg/min
Baseline to 12 weeks
Change in frailty
Time Frame: Baseline to 12 weeks
Measured by the Fried criteria. Measured by presence of 3 out of 5 frailty symptoms.
Baseline to 12 weeks
Change in general quality of life
Time Frame: 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.
Baseline to 12 weeks
Change in disease-specific quality of life
Time Frame: 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.
Baseline to 12 weeks
Change in depressive symptoms
Time Frame: 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.
Baseline to 12 weeks
Change in anxiety
Time Frame: 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.
Baseline to 12 weeks
Change in cognitive function
Time Frame: 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.
Baseline to 12 weeks
Change in response to a specific traumatic event
Time Frame: 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.
Baseline to 12 weeks
Short term post-heart transplantation outcomes
Time Frame: 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.
One year post-heart transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Heart Institute Research Corporation

Investigators

  • Principal Investigator: Jennifer Reed, Ph.D, R.Kin, Ottawa Heart Institute Research Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2018

Primary Completion (Actual)

February 2, 2020

Study Completion (Actual)

February 2, 2020

Study Registration Dates

First Submitted

October 27, 2016

First Submitted That Met QC Criteria

November 3, 2016

First Posted (Estimate)

November 8, 2016

Study Record Updates

Last Update Posted (Actual)

April 29, 2021

Last Update Submitted That Met QC Criteria

April 28, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20160753-01H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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