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High Intensity Training in de Novo Heart Transplant Recipients in Scandinavia

NCT ID: NCT01796379

Last Updated: 2019-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2019-12-05

Brief Summary

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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

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Conditions

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Heart Transplant Recipients Physical Fitness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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High Intensity Interval Training

Group Type EXPERIMENTAL

High Intensity Interval Training

Intervention Type BEHAVIORAL

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.

Group Type OTHER

Moderate Training

Intervention Type BEHAVIORAL

Interventions

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High Intensity Interval Training

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

Intervention Type BEHAVIORAL

Moderate Training

Intervention Type BEHAVIORAL

Other Intervention Names

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Regular exercise training offered to all heart transplant recipients (usual care)

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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South-Eastern Norway Regional Health Authority

OTHER

Sponsor Role collaborator

Norwegian Health Association

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kari Nytrøen

Post doc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lars Gullestad, Professor

Role: PRINCIPAL_INVESTIGATOR

Oslo Unversity Hospital

Locations

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Copenhagen University Hospital

Copenhagen, , Denmark

Site Status

Oslo University Hospital Rikshospitalet

Oslo, , Norway

Site Status

Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status

Countries

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Denmark Norway Sweden

References

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Nytroen K, Rustad LA, Aukrust P, Ueland T, Hallen 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.

Reference Type BACKGROUND
PMID: 22900793 (View on PubMed)

Nytroen K, Yardley M, Rolid K, Bjorkelund 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.

Reference Type BACKGROUND
PMID: 26856221 (View on PubMed)

Rolid K, Andreassen AK, Yardley M, Bjorkelund E, Karason K, Wigh JP, Dall CH, Gustafsson F, Gullestad L, Nytroen K. Clinical features and determinants of VO2peak in de novo heart transplant recipients. World J Transplant. 2018 Sep 10;8(5):188-197. doi: 10.5500/wjt.v8.i5.188.

Reference Type BACKGROUND
PMID: 30211027 (View on PubMed)

Rafique M, Solberg OG, Gullestad L, Bendz B, Murbraech K, Nytroen K, Rolid K, Lunde K. Effects of high-intensity interval training on cardiac remodelling, function and coronary microcirculation in de novo heart transplant patients: a substudy of the HITTS randomised controlled trial. BMJ Open Sport Exerc Med. 2023 Jul 9;9(3):e001331. doi: 10.1136/bmjsem-2022-001331. eCollection 2023.

Reference Type DERIVED
PMID: 37440977 (View on PubMed)

Rolid K, Andreassen AK, Yardley M, Gude E, Bjorkelund E, Authen AR, Grov I, Pettersen KI, Dall CH, Karason K, Broch K, Gullestad L, Nytroen K. High-intensity interval training and health-related quality of life in de novo heart transplant recipients - results from a randomized controlled trial. Health Qual Life Outcomes. 2020 Aug 17;18(1):283. doi: 10.1186/s12955-020-01536-4.

Reference Type DERIVED
PMID: 32807179 (View on PubMed)

Nytroen K, Rolid K, Yardley M, Gullestad L. Effect of high-intensity interval training in young heart transplant recipients: results from two randomized controlled trials. BMC Sports Sci Med Rehabil. 2020 Jun 4;12:35. doi: 10.1186/s13102-020-00180-1. eCollection 2020.

Reference Type DERIVED
PMID: 32518655 (View on PubMed)

Rolid K, Andreassen AK, Yardley M, Gude E, Bjorkelund E, Authen AR, Grov I, Broch K, Gullestad L, Nytroen K. Long-term effects of high-intensity training vs moderate intensity training in heart transplant recipients: A 3-year follow-up study of the randomized-controlled HITTS study. Am J Transplant. 2020 Dec;20(12):3538-3549. doi: 10.1111/ajt.16087. Epub 2020 Jun 28.

Reference Type DERIVED
PMID: 32484261 (View on PubMed)

Nytroen K, Rolid K, Andreassen AK, Yardley M, Gude E, Dahle DO, Bjorkelund E, Relbo Authen A, Grov I, Philip Wigh J, Have Dall C, Gustafsson F, Karason K, Gullestad L. Effect of High-Intensity Interval Training in De Novo Heart Transplant Recipients in Scandinavia. Circulation. 2019 May 7;139(19):2198-2211. doi: 10.1161/CIRCULATIONAHA.118.036747.

Reference Type DERIVED
PMID: 30773030 (View on PubMed)

Other Identifiers

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9378

Identifier Type: -

Identifier Source: org_study_id