High Intensity Training in de Novo Heart Transplant Recipients in Scandinavia (HITTS)

December 6, 2019 updated by: Kari Nytrøen, Oslo University Hospital
Compared to end-stage heart failure, a patient's situation is usually greatly improved after a heart transplant (HTx), but the exercise capacity remains sub-normal, also long-term, ranging from 50 to 70% in most studies. While effective rehabilitation, including regular exercise, is considered an effective tool of improving health related quality of life (HRQoL) and prognosis of cardiac patients in general, the knowledge about and the effect of different rehabilitation programs among HTx recipients is limited. Exercise training is considered one of the most central parts in rehabilitation, but the mode of exercise used in different studies varies considerably. It is documented that high intensity interval training (HIT) has superior effects compared to training with moderate intensity in cardiac and heart failure patients. In contrast, HTx recipients have a denervated heart, and HIT had been considered unphysiological. However, the investigators have recently demonstrated highly beneficial effects on exercise capacity, muscle strength, body composition, reduced progression of cardiac allograft vasculopathy and HRQoL among long-term HTx recipients. In the present study the investigators want to test the hypothesis that systematic aerobic exercise with high intensity improve exercise capacity also in newly transplanted recipients, and secondarily that it gives favourable effects on the heart, peripheral circulation and a better HRQoL.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

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

  • Denmark
      • Copenhagen, Denmark
        • Copenhagen University Hospital
  • Norway
      • Oslo, Norway, 0424
        • Oslo University Hospital Rikshospitalet
  • Sweden
      • Gothenburg, Sweden
        • Sahlgrenska University Hospital

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:

  • Clinically stable HTx recipients approximately 8-12 weeks after HTx.
  • Age > 18 years, both sexes
  • Received immunosuppressive therapy as per local protocol.
  • Patient willing and capable of giving written informed consent for study participation and anticipated to be able to participate in the study for 9- 12 months.

Exclusion Criteria:

  • Unstable condition or postoperative complications
  • Recent severe rejection episodes
  • Physical disabilities which prevent participation
  • Other diseases or disabilities that contradict/refrain from exercise.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High Intensity Interval Training
Behavioral: High Intensity Interval Training
9 months of high intensity interval based aerobic exercise (3 times/week)
Other: Moderate Training
Regular exercise training offered as usual care to all heart transplant recipients.
Behavioral: Moderate Training
Other Names:
  • Regular exercise training offered to all heart transplant recipients (usual care)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of exercise on peak oxygen uptake
Time Frame: Baseline to one year
Change in ml/kg/min
Baseline to one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of exercise on muscle strength
Time Frame: Baseline to one year
Change measured in Newtonmeter and Joule
Baseline to one year
Effect of exercise on progression of coronary artery vasculopathy (CAV)
Time Frame: Baseline to one year
Change measured by intravascular ultrasound; change in maximum intimal thickness, total atheroma volume, percent atheroma volume and virtual histology.
Baseline to one year
Effect of exercise on chronotropic responses
Time Frame: Baseline to one year
Change in heart rate response, including changes in minimum and maximum heart rate and changes in chronotropic response index.
Baseline to one year
Effect of exercise on myocardial function
Time Frame: Baseline to one year
Change in echocardiographic parametres such as stroke volume, cardiac index and ejection fraction.
Baseline to one year
Effect of exercise on endothelial function
Time Frame: Baseline to one year
Change in endothelial function measured by flow mediated dilatation and EndoPat
Baseline to one year
Effect of exercise on biomarkers
Time Frame: Baseline to one year
Neuroendocrine, inflammatory and immunological biomarkers.
Baseline to one year
Effect of exercise on health related quality of life
Time Frame: Baseline to one year
Change measured on visual analogue scales and questionnaires
Baseline to one year
Effect of exercise on safety and tolerability
Time Frame: Baseline to 3 years follow-up
Measured by number of serious adverse effects related to the intervention
Baseline to 3 years follow-up
Long-term effects of exercise
Time Frame: Baseline to 3 years follow-up
Long-term effects will be measured by all outcomes listed above, including number of serious adverse effects.
Baseline to 3 years follow-up

Collaborators and Investigators

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

Sponsor

Oslo University Hospital

Collaborators

South-Eastern Norway Regional Health Authority
Norwegian Health Association

Investigators

  • Principal Investigator: Lars Gullestad, Professor, Oslo Unversity Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 1, 2013

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 5, 2019

Study Registration Dates

First Submitted

February 18, 2013

First Submitted That Met QC Criteria

February 20, 2013

First Posted (Estimate)

February 21, 2013

Study Record Updates

Last Update Posted (Actual)

December 9, 2019

Last Update Submitted That Met QC Criteria

December 6, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 9378

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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