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Heart FailurePREHABNCT02957955

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

A study testing High-Intensity Interval Training in people with Heart Failure, run by Ottawa Heart Institute Research Corporation at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
High-Intensity Interval Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
2 sitesCanada
Study dates
1 May 2018to 2 Feb 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Advanced heart failure and listed for heart transplantation.
  • Able to perform a symptom-limited exercise test.
  • Age =>18 years old.
  • Able to provide informed consent.

Who cannot join

  • Currently participating in a structured exercise training program (> 2 times per week)
  • Status 4 priority listing for heart transplantation.
  • Myocardial infarction =<7 days.
  • Heart failure with hemodynamic instability.
  • Hypertrophic obstructive cardiomyopathy with symptomatic left ventricular outflow tract gradient =>30 mmHg.

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y4W7

  • University Health Network

    Toronto, Ontario

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Conditions
Heart Failure
Being tested
High-Intensity Interval Training
Keywords
Heart failure
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High-Intensity Interval TrainingBehavioural

    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).

Study groups in NCT02957955
Study groupRoleWhat they receive
InterventionalExperimentalGroup 1. Usual care + High-Intensity Interval Training, Nutritional Workshop, Stress Management Course.
Receives: Behavioral: High-Intensity Interval Training
Non interventionalNo interventionGroup 2. Usual care. Patients are encouraged to remain physically active, although they do not participate in a regular structured exercise training program.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in functional capacity

    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.

    Measured: Baseline to 12 weeks

Secondary outcomes (9)

  1. Change in aerobic power

    Measured using expired VO2 gas samples, measured in L/min, ml/kg/min

    Measured: Baseline to 12 weeks

  2. Change in frailty

    Measured by the Fried criteria. Measured by presence of 3 out of 5 frailty symptoms.

    Measured: Baseline to 12 weeks

  3. Change in general quality of life

    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.

    Measured: Baseline to 12 weeks

  4. Change in disease-specific quality of life

    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.

    Measured: Baseline to 12 weeks

  5. Change in depressive symptoms

    Measured by the Beck Depression Inventory II (BDI-II). It contains 21-questions, each answer being scored on a scale of 0 to 3.

    Measured: Baseline to 12 weeks

  6. Change in anxiety

    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.

    Measured: Baseline to 12 weeks

  7. Change in cognitive function

    Measured by the Montreal Cognitive Assessment (MOCA). The MOCA is made up of 8 subscales, scores are totaled; maximum score is 30 points.

    Measured: Baseline to 12 weeks

  8. Change in response to a specific traumatic event

    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.

    Measured: Baseline to 12 weeks

  9. Short term post-heart transplantation outcomes

    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.

    Measured: One year post-heart transplantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2016 (estimated)
  2. Study start1 May 2018
  3. Primary completion2 Feb 2020
  4. Study completion2 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02957955
Sponsor's protocol ID
20160753-01H
Acronym
PREHAB
Status last verified
Apr 2021
First submitted
27 Oct 2016
Last updated
29 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 40894839

Questions about this trial

What is this clinical trial studying?

A study testing High-Intensity Interval Training in people with Heart Failure, run by Ottawa Heart Institute Research Corporation at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in functional capacity (time frame: Baseline to 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02957955, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2021.

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