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| Name | Class |
|---|---|
| South-Eastern Norway Regional Health Authority | OTHER |
| Norwegian Health Association | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Intensity Interval Training | Experimental |
| |
| Moderate Training | Other | Regular exercise training offered as usual care to all heart transplant recipients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Intensity Interval Training | Behavioral | 9 months of high intensity interval based aerobic exercise (3 times/week) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of exercise on peak oxygen uptake | Change in ml/kg/min | Baseline to one year |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of exercise on muscle strength | Change measured in Newtonmeter and Joule | Baseline to one year |
| 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. |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars Gullestad, Professor | Oslo Unversity Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copenhagen University Hospital | Copenhagen | Denmark | ||||
| Oslo University Hospital Rikshospitalet |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22900793 | Background | 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. | |
| 26856221 |
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| ID | Term |
|---|---|
| D000072696 | High-Intensity Interval Training |
| ID | Term |
|---|---|
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
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| Moderate Training | Behavioral |
|
|
| Baseline to one year |
| 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 |
| Effect of exercise on myocardial function | Change in echocardiographic parametres such as stroke volume, cardiac index and ejection fraction. | Baseline to one year |
| Effect of exercise on endothelial function | Change in endothelial function measured by flow mediated dilatation and EndoPat | Baseline to one year |
| Effect of exercise on biomarkers | Neuroendocrine, inflammatory and immunological biomarkers. | Baseline to one year |
| Effect of exercise on health related quality of life | Change measured on visual analogue scales and questionnaires | Baseline to one year |
| Effect of exercise on safety and tolerability | Measured by number of serious adverse effects related to the intervention | Baseline to 3 years follow-up |
| 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 |
| Oslo |
| 0424 |
| Norway |
| Sahlgrenska University Hospital | Gothenburg | Sweden |
| 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. |
| 30211027 | 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. |
| 37440977 | Derived | 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. |
| 32807179 | 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. |
| 32518655 | 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. |
| 32484261 | 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. |
| 30773030 | 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. |
| D009142 |
| Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |