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High Intensity Training in de Novo Heart Transplant Recipients in Scandinavia

High Intensity Training in de Novo Heart Transplant Recipients in Scandinavia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01796379
Acronym
HITTS
Enrollment
80
Registered
2013-02-21
Start date
2013-02-28
Completion date
2019-12-05
Last updated
2019-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Transplant Recipients, Physical Fitness

Brief summary

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.

Interventions

BEHAVIORALHigh Intensity Interval Training

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

Sponsors

South-Eastern Norway Regional Health Authority
CollaboratorOTHER
Norwegian Health Association
CollaboratorOTHER
Oslo University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Effect of exercise on peak oxygen uptakeBaseline to one yearChange in ml/kg/min

Secondary

MeasureTime frameDescription
Effect of exercise on progression of coronary artery vasculopathy (CAV)Baseline to one yearChange measured by intravascular ultrasound; change in maximum intimal thickness, total atheroma volume, percent atheroma volume and virtual histology.
Effect of exercise on chronotropic responsesBaseline to one yearChange in heart rate response, including changes in minimum and maximum heart rate and changes in chronotropic response index.
Effect of exercise on myocardial functionBaseline to one yearChange in echocardiographic parametres such as stroke volume, cardiac index and ejection fraction.
Effect of exercise on endothelial functionBaseline to one yearChange in endothelial function measured by flow mediated dilatation and EndoPat
Effect of exercise on muscle strengthBaseline to one yearChange measured in Newtonmeter and Joule
Effect of exercise on health related quality of lifeBaseline to one yearChange measured on visual analogue scales and questionnaires
Effect of exercise on safety and tolerabilityBaseline to 3 years follow-upMeasured by number of serious adverse effects related to the intervention
Long-term effects of exerciseBaseline to 3 years follow-upLong-term effects will be measured by all outcomes listed above, including number of serious adverse effects.
Effect of exercise on biomarkersBaseline to one yearNeuroendocrine, inflammatory and immunological biomarkers.

Countries

Denmark, Norway, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026