Cardiovascular Prehabilitation in Patients Awaiting Heart Transplantation (PREHAB HTx Study)
NCT ID: NCT02957955
Last Updated: 2021-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
6 participants
INTERVENTIONAL
2018-05-01
2020-02-02
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Interventional
Group 1. Usual care + High-Intensity Interval Training, Nutritional Workshop, Stress Management Course.
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).
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.
No interventions assigned to this group
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
2. Able to perform a symptom-limited exercise test.
3. Age =\>18 years old.
4. Able to provide informed consent.
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Ottawa Heart Institute Research Corporation
OTHER
Responsible Party
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Principal Investigators
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Jennifer Reed, Ph.D, R.Kin
Role: PRINCIPAL_INVESTIGATOR
Ottawa Heart Institute Research Corporation
Locations
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University of Ottawa Heart Institute
Ottawa, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
Countries
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References
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Reed JL, Tulloch HE, Ross H, Terada T, Mistura M, Marcal IR, Oh P, Chih S. Cardiovascular Prehabilitation in Patients Awaiting Heart Transplantation- Addressing Clinical Needs (the PREHAB HTx Study). CJC Open. 2025 May 22;7(8):1110-1119. doi: 10.1016/j.cjco.2025.05.009. eCollection 2025 Aug.
Other Identifiers
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20160753-01H
Identifier Type: -
Identifier Source: org_study_id
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