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Completed

NCT Number: NCT01796379

High Intensity Training in de Novo Heart Transplant Recipients in Scandinavia

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Copenhagen University Hospital, Copenhagen, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High Intensity Interval Training

Behavioral

9 months of high intensity interval based aerobic exercise (3 times/week)

Moderate training

Behavioral

Other names: Regular exercise training offered to all heart transplant recipients (usual care)

Primary outcomes

  1. Effect of exercise on peak oxygen uptake

    Time frame: Baseline to one year

    Change in ml/kg/min

Secondary outcomes

  1. Effect of exercise on muscle strength

    Time frame: Baseline to one year

    Change measured in Newtonmeter and Joule

  2. 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.

  3. 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.

  4. 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.

  5. Effect of exercise on endothelial function

    Time frame: Baseline to one year

    Change in endothelial function measured by flow mediated dilatation and EndoPat

  6. Effect of exercise on biomarkers

    Time frame: Baseline to one year

    Neuroendocrine, inflammatory and immunological biomarkers.

  7. Effect of exercise on health related quality of life

    Time frame: Baseline to one year

    Change measured on visual analogue scales and questionnaires

  8. 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

  9. 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.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Norwegian Health Association
  • South-Eastern Norway Regional Health Authority

Registry information

Acronym: HITTS

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Feb 21, 2013
Registry last updated
Dec 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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