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

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ClinicalTrials.gov Identifier: NCT02957955
Recruitment Status : Recruiting
First Posted : November 8, 2016
Last Update Posted : June 21, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Heart Failure Behavioral: High-Intensity Interval Training Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Cardiovascular Prehabilitation in Patients Awaiting Heart Transplantation - Addressing Clinical Needs (PREHAB HTx Study)
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change in aerobic power [ Time Frame: Baseline to 12 weeks ]
    Measured using expired VO2 gas samples, measured in L/min, ml/kg/min

  2. Change in frailty [ Time Frame: Baseline to 12 weeks ]
    Measured by the Fried criteria. Measured by presence of 3 out of 5 frailty symptoms.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02957955


Contacts
Contact: Jennifer Reed, Ph.D, R.Kin 6136967392 ext 67392 jreed@ottawaheart.ca
Contact: Anna Clarke 613-696-7000 ext 15944 aclarke@ottawaheart.ca

Locations
Canada, Ontario
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y4W7
Contact: Jennifer L Reed, PhD    6136967392 ext 67392    jreed@ottawaheart.ca   
University Health Network Recruiting
Toronto, Ontario, Canada
Contact: Natalia Nugaeva         
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Investigators
Principal Investigator: Jennifer Reed, Ph.D, R.Kin Ottawa Heart Institute Research Corporation

Responsible Party: Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT02957955     History of Changes
Other Study ID Numbers: 20160753-01H
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ottawa Heart Institute Research Corporation:
Heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases