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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Heart Transplant Recipients; Physical Fitness	Behavioral: High Intensity Interval Training; Behavioral: Moderate Training	Not Applicable

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	80 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	High Intensity Training in de Novo Heart Transplant Recipients in Scandinavia
Actual Study Start Date :	February 2013
Estimated Primary Completion Date :	December 2019
Estimated Study Completion Date :	December 2035

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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)

Outcome Measures

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Primary Outcome Measures :

1. Effect of exercise on peak oxygen uptake [ Time Frame: Baseline to one year ]
   Change in ml/kg/min

Secondary Outcome Measures :

1. Effect of exercise on muscle strength [ Time Frame: Baseline to one year ]
   Change measured in Newtonmeter and Joule
2. 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.
3. 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.
4. 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.
5. Effect of exercise on endothelial function [ Time Frame: Baseline to one year ]
   Change in endothelial function measured by flow mediated dilatation and EndoPat
6. Effect of exercise on biomarkers [ Time Frame: Baseline to one year ]
   Neuroendocrine, inflammatory and immunological biomarkers.
7. Effect of exercise on health related quality of life [ Time Frame: Baseline to one year ]
   Change measured on visual analogue scales and questionnaires
8. 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
9. 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.

Eligibility Criteria

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

Criteria

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Denmark
Copenhagen University Hospital
Copenhagen, Denmark
Norway
Oslo University Hospital Rikshospitalet
Oslo, Norway, 0424
Sweden
Sahlgrenska University Hospital
Gothenburg, Sweden

Sponsors and Collaborators

Oslo University Hospital

South-Eastern Norway Regional Health Authority

Norwegian Health Association

Investigators

Principal Investigator:	Lars Gullestad, Professor	Oslo Unversity Hospital

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Nytrøen K, Rustad LA, Aukrust P, Ueland T, Hallén J, Holm I, Rolid K, Lekva T, Fiane AE, Amlie JP, Aakhus S, Gullestad L. High-intensity interval training improves peak oxygen uptake and muscular exercise capacity in heart transplant recipients. Am J Transplant. 2012 Nov;12(11):3134-42. doi: 10.1111/j.1600-6143.2012.04221.x. Epub 2012 Aug 17.

Nytrøen K, Yardley M, Rolid K, Bjørkelund E, Karason K, Wigh JP, Dall CH, Arora S, Aakhus S, Lunde K, Solberg OG, Gustafsson F, Prescott EI, Gullestad L. Design and rationale of the HITTS randomized controlled trial: Effect of High-intensity Interval Training in de novo Heart Transplant Recipients in Scandinavia. Am Heart J. 2016 Feb;172:96-105. doi: 10.1016/j.ahj.2015.10.011. Epub 2015 Oct 21. Review.

Responsible Party:	Kari Nytrøen, Post doc, Oslo University Hospital
ClinicalTrials.gov Identifier:	NCT01796379 History of Changes
Other Study ID Numbers:	9378
First Posted:	February 21, 2013
Last Update Posted:	January 19, 2018
Last Verified:	January 2018

Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No