High Intensity Training in de Novo Heart Transplant Recipients in Scandinavia

Not Applicable

Completed

• Conditions: Heart Transplant Recipients; Physical Fitness
• Interventions: Behavioral: Moderate Training; Behavioral: High Intensity Interval Training

• Registration Number: NCT01796379
• Lead Sponsor: Oslo University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-18
• Study First Submitted QC: 2013-02-20
• Study First Posted: 2013-02-21
• Status Verified: 2019-12
• Primary Completion: 2019-12
• Study Completion: 2019-12-05
• Last Update Submitted: 2019-12-06
• Last Update Posted: 2019-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moderate Training	Moderate Training	Regular exercise training offered as usual care to all heart transplant recipients.
High Intensity Interval Training	High Intensity Interval Training	-

Primary Outcome Measures

Name	Time	Method
Effect of exercise on peak oxygen uptake	Baseline to one year	Change in ml/kg/min

Secondary Outcome Measures

Name	Time	Method
Effect of exercise on health related quality of life	Baseline to one year	Change measured on visual analogue scales and questionnaires
Effect of exercise on chronotropic responses	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 muscle strength	Baseline to one year	Change measured in Newtonmeter and Joule
Effect of exercise on endothelial function	Baseline to one year	Change in endothelial function measured by flow mediated dilatation and EndoPat
Effect of exercise on biomarkers	Baseline to one year	Neuroendocrine, inflammatory and immunological biomarkers.
Effect of exercise on safety and tolerability	Baseline to 3 years follow-up	Measured by number of serious adverse effects related to the intervention
Effect of exercise on myocardial function	Baseline to one year	Change in echocardiographic parametres such as stroke volume, cardiac index and ejection fraction.
Long-term effects of exercise	Baseline to 3 years follow-up	Long-term effects will be measured by all outcomes listed above, including number of serious adverse effects.
Effect of exercise on progression of coronary artery vasculopathy (CAV)	Baseline to one year	Change measured by intravascular ultrasound; change in maximum intimal thickness, total atheroma volume, percent atheroma volume and virtual histology.

Trial Locations

Locations (3)

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden

Oslo University Hospital Rikshospitalet; 🇳🇴 Oslo, Norway

Copenhagen University Hospital; 🇩🇰 Copenhagen, Denmark