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

University of Oslo (UIO) logo

University of Oslo (UIO)

Status

Completed

Conditions

Physical Fitness
Heart Transplant Recipients

Treatments

Behavioral: High Intensity Interval Training
Behavioral: Moderate Training

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

80 participants in 2 patient groups

High Intensity Interval Training
Experimental group
Treatment:
Behavioral: High Intensity Interval Training
Moderate Training
Other group
Description:
Regular exercise training offered as usual care to all heart transplant recipients.
Treatment:
Behavioral: Moderate Training

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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