High Intensity Training in de Novo Heart Transplant Recipients in Scandinavia

NCT01796379 | Completed

• 1 other identifier: 9378
• Study Type: interventional
• Target: 80
• Locations: 3 countries
• Sites: 3

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.

Conditions

Heart Transplant Recipients; Physical Fitness

Outcome Measures

Primary Outcomes (1)

• Effect of exercise on peak oxygen uptake

  Change in ml/kg/min

  Baseline to one year

Secondary Outcomes (9)

• Effect of exercise on muscle strength

  Baseline to one year

• Effect of exercise on progression of coronary artery vasculopathy (CAV)

  Baseline to one year

• Effect of exercise on chronotropic responses

  Baseline to one year

• Effect of exercise on myocardial function

  Baseline to one year

• Effect of exercise on endothelial function

  Baseline to one year

Study Arms (2)

High Intensity Interval Training

EXPERIMENTAL

Behavioral: High Intensity Interval Training

Moderate Training

OTHER

Regular exercise training offered as usual care to all heart transplant recipients.

Behavioral: Moderate Training

Interventions

High Intensity Interval Training BEHAVIORAL

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

High Intensity Interval Training

Moderate Training BEHAVIORAL

Also known as: Regular exercise training offered to all heart transplant recipients (usual care)

Moderate Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Unstable condition or postoperative complications
• Recent severe rejection episodes
• Physical disabilities which prevent participation
• Other diseases or disabilities that contradict/refrain from exercise.

Sponsors & Collaborators

• Oslo University Hospital: lead
• South-Eastern Norway Regional Health Authority: collaborator
• Norwegian Health Association: collaborator

Study Sites (3)

Copenhagen University Hospital

Copenhagen, Denmark

Location

Oslo University Hospital Rikshospitalet

Oslo, 0424, Norway

Location

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Related Publications (8)

• 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.

  PMID: 22900793 BACKGROUND

• 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.

  PMID: 26856221 BACKGROUND

• 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.

  PMID: 30211027 BACKGROUND

• 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.

  PMID: 37440977 DERIVED

• 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.

  PMID: 32807179 DERIVED

• 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.

  PMID: 32518655 DERIVED

• 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.

  PMID: 32484261 DERIVED

• 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.

  PMID: 30773030 DERIVED

MeSH Terms

Interventions

High-Intensity Interval Training

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Lars Gullestad, Professor

  Oslo Unversity Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post doc

Study Record Dates

• First Submitted: February 18, 2013
• First Posted: February 21, 2013
• Study Start: February 1, 2013
• Primary Completion: December 1, 2019
• Study Completion: December 5, 2019
• Last Updated: December 9, 2019

Record last verified: 2019-12

Locations

NO (1); DK (1); SE (1)