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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by Oslo University Hospital
Information provided by (Responsible Party):
Oslo University Hospital Identifier:
First received: February 18, 2013
Last updated: January 22, 2016
Last verified: December 2015
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.

Condition Intervention
Heart Transplant Recipients
Physical Fitness
Behavioral: High Intensity Interval Training
Behavioral: Moderate Training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: High Intensity Training in de Novo Heart Transplant Recipients in Scandinavia

Resource links provided by NLM:

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Effect of exercise on peak oxygen uptake [ Time Frame: Baseline to one year ]
    Change in ml/kg/min

Secondary Outcome Measures:
  • Effect of exercise on muscle strength [ Time Frame: Baseline to one year ]
    Change measured in Newtonmeter and Joule

  • 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.

  • 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.

  • 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.

  • Effect of exercise on endothelial function [ Time Frame: Baseline to one year ]
    Change in endothelial function measured by flow mediated dilatation and EndoPat

  • Effect of exercise on biomarkers [ Time Frame: Baseline to one year ]
    Neuroendocrine, inflammatory and immunological biomarkers.

  • Effect of exercise on health related quality of life [ Time Frame: Baseline to one year ]
    Change measured on visual analogue scales and questionnaires

  • 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

  • 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.

Estimated Enrollment: 120
Study Start Date: February 2013
Estimated Study Completion Date: December 2035
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High Intensity Interval Training Behavioral: High Intensity Interval Training
9 months of high intensity interval based aerobic exercise (3 times/week)
Moderate Training
Regular exercise training offered as usual care to all heart transplant recipients.
Behavioral: Moderate Training
Other Name: Regular exercise training offered to all heart transplant recipients (usual care)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01796379

Contact: Lars Gullestad, Professor
Contact: Kari Nytrøen, PhD

Copenhagen University Hospital Recruiting
Copenhagen, Denmark
Oslo University Hospital Rikshospitalet Recruiting
Oslo, Norway, 0424
Contact: Kari Nytrøen, PhD   
Principal Investigator: Lars Gullestad, Professor         
Sub-Investigator: Marianne Yardley, MD         
Sahlgrenska University Hospital Recruiting
Gothenburg, Sweden
Sponsors and Collaborators
Oslo University Hospital
Principal Investigator: Lars Gullestad, Professor Oslo Unversity Hospital
  More Information

Responsible Party: Oslo University Hospital Identifier: NCT01796379     History of Changes
Other Study ID Numbers: 9378
Study First Received: February 18, 2013
Last Updated: January 22, 2016 processed this record on May 22, 2017