High Intensity Training in de Novo Heart Transplant Recipients in Scandinavia

Physical Fitness Clinical Trial

— HITTS  

Official title:

High Intensity Training in de Novo Heart Transplant Recipients in Scandinavia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01796379
• Other study ID #: 9378
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Est. completion date: December 5, 2019

Study information

• Verified date: December 2019
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 5, 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Transplant Recipients
• Physical Fitness

Intervention

Behavioral:
• High Intensity Interval Training
9 months of high intensity interval based aerobic exercise (3 times/week)
• Moderate Training

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital	Copenhagen
Norway	Oslo University Hospital Rikshospitalet	Oslo
Sweden	Sahlgrenska University Hospital	Gothenburg

Sponsors (3)

Lead Sponsor	Collaborator
Oslo University Hospital	Norwegian Health Association, South-Eastern Norway Regional Health Authority

Countries where clinical trial is conducted

Denmark,  Norway,  Sweden, 

References & Publications (3)

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. — View Citation

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. — View Citation

Rolid K, Andreassen AK, Yardley M, Bjørkelund E, Karason K, Wigh JP, Dall CH, Gustafsson F, Gullestad L, Nytrøen K. Clinical features and determinants of VO(2peak) in de novo heart transplant recipients. World J Transplant. 2018 Sep 10;8(5):188-197. doi: 10.5500/wjt.v8.i5.188. — View Citation

Outcome

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