High Intensity Training in de Novo Heart Transplant Recipients in Scandinavia (HITTS)
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Purpose
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 |
|---|---|
|
Exercise Capacity |
Behavioral: High Intensity Interval Training Behavioral: Moderate Training |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | High Intensity Training in de Novo Heart Transplant Recipients in Scandinavia |
- Peak oxygen uptake [ Time Frame: Change from baseline to one year ] [ Designated as safety issue: No ]
- Muscle strength [ Time Frame: Change from baseline to one year ] [ Designated as safety issue: No ]
- Progression of coronary artery vasculopathy [ Time Frame: Change from baseline to one year ] [ Designated as safety issue: No ]development of coronary artery vasculopathy (CAV) as assessed by intravascular ultrasound (IVUS).
- Reinnervation [ Time Frame: Change from baseline to one year ] [ Designated as safety issue: No ]Reinnervation as assessed by chronotropic response during exercise
- Myocardial function [ Time Frame: Change from baseline to one year ] [ Designated as safety issue: No ]myocardial function as assessed by echocardiography
- Endothelial function [ Time Frame: Change from baseline to one year ] [ Designated as safety issue: No ]endothelial function as assessed by Endopath
- Biomarkers [ Time Frame: Change from baseline to one year ] [ Designated as safety issue: No ]neuroendocrine, inflammatory and immunological biomarkers.
- Health related quality of life [ Time Frame: Change from baseline to one year ] [ Designated as safety issue: No ]health related quality of life (HRQoL) measured by Short Form 36 and Hospital Anxiety and Depression Scale.
- Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to one year ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 120 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | December 2030 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: High Intensity 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)
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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| Contact: Lars Gullestad, Professor | lars.gullestad@medisin.uio.no | |
| Contact: Kari Nytrøen, PhD student | knytroen@ous-hf.no |
| Denmark | |
| Aarhus University Hospital | Not yet recruiting |
| Aarhus, Denmark | |
| Copenhagen University Hospital | Not yet recruiting |
| Copenhagen, Denmark | |
| Norway | |
| Oslo University Hospital Rikshospitalet | Recruiting |
| Oslo, Norway, 0424 | |
| Contact: Kari Nytrøen, PhD student knytroen@ous-hf.no | |
| Principal Investigator: Lars Gullestad, Professor | |
| Sweden | |
| Sahlgrenska University Hospital | Not yet recruiting |
| Gothenburg, Sweden | |
More Information
Publications:
| Responsible Party: | Oslo University Hospital |
| ClinicalTrials.gov Identifier: | NCT01796379 History of Changes |
| Other Study ID Numbers: | 9378 |
| Study First Received: | February 18, 2013 |
| Last Updated: | February 20, 2013 |
| Health Authority: | Norway:National Committee for Medical and Health Research Ethics |
ClinicalTrials.gov processed this record on May 16, 2013