NCT02957955

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started May 2018

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 8, 2016

Completed
1.5 years until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2020

Completed
Last Updated

April 29, 2021

Status Verified

April 1, 2021

Enrollment Period

1.8 years

First QC Date

October 27, 2016

Last Update Submit

April 28, 2021

Conditions

Heart Failure

Keywords

Heart failure

Outcome Measures

Primary Outcomes (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.

    Baseline to 12 weeks

Secondary Outcomes (9)

  • Change in aerobic power

    Baseline to 12 weeks

  • Change in frailty

    Baseline to 12 weeks

  • Change in general quality of life

    Baseline to 12 weeks

  • Change in disease-specific quality of life

    Baseline to 12 weeks

  • Change in depressive symptoms

    Baseline to 12 weeks

  • +4 more secondary outcomes

Study Arms (2)

Interventional

EXPERIMENTAL

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

Behavioral: High-Intensity Interval Training

Non interventional

NO INTERVENTION

Group 2. Usual care. Patients are encouraged to remain physically active, although they do not participate in a regular structured exercise training program.

Interventions

High-Intensity Interval TrainingBEHAVIORAL

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).

Interventional

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y4W7, Canada

Location

University Health Network

Toronto, Ontario, Canada

Location

Related Publications (1)

  • 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.

    PMID: 40894839DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jennifer Reed, Ph.D, R.Kin

    Ottawa Heart Institute Research Corporation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2016

First Posted

November 8, 2016

Study Start

May 1, 2018

Primary Completion

February 2, 2020

Study Completion

February 2, 2020

Last Updated

April 29, 2021

Record last verified: 2021-04

Locations

CA(2)