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Heart Transplant RecipientsHITTSNCT01796379

High Intensity Training in de Novo Heart Transplant Recipients in Scandinavia

A study testing High Intensity Interval Training and Moderate Training in people with Heart Transplant Recipients and Physical Fitness, run by Oslo University Hospital at 3 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Transplant Recipients, Physical Fitness
What is being tested?
High Intensity Interval Training and Moderate Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
3 sitesin 3 countries
Study dates
Feb 2013to 5 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

3 sites in 3 countries.

3 sites in 3 countries

Denmark1 site

  • Copenhagen University Hospital

    Copenhagen

Other trials in Denmark

Norway1 site

  • Oslo University Hospital Rikshospitalet

    Oslo, 0424

Other trials in Norway

Sweden1 site

  • Sahlgrenska University Hospital

    Gothenburg

Other trials in Sweden

About this study

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.

Being tested
High Intensity Interval Training, Moderate Training

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High Intensity Interval TrainingBehavioural

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

  • Moderate TrainingBehavioural

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

Study groups in NCT01796379
Study groupRoleWhat they receive
High Intensity Interval TrainingExperimentalNot described
Receives: Behavioral: High Intensity Interval Training
Moderate TrainingOtherRegular exercise training offered as usual care to all heart transplant recipients.
Receives: Behavioral: Moderate Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effect of exercise on peak oxygen uptake

    Change in ml/kg/min

    Measured: Baseline to one year

Secondary outcomes (9)

  1. Effect of exercise on muscle strength

    Change measured in Newtonmeter and Joule

    Measured: Baseline to one year

  2. 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.

    Measured: Baseline to one year

  3. 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.

    Measured: Baseline to one year

  4. Effect of exercise on myocardial function

    Change in echocardiographic parametres such as stroke volume, cardiac index and ejection fraction.

    Measured: Baseline to one year

  5. Effect of exercise on endothelial function

    Change in endothelial function measured by flow mediated dilatation and EndoPat

    Measured: Baseline to one year

  6. Effect of exercise on biomarkers

    Neuroendocrine, inflammatory and immunological biomarkers.

    Measured: Baseline to one year

  7. Effect of exercise on health related quality of life

    Change measured on visual analogue scales and questionnaires

    Measured: Baseline to one year

  8. Effect of exercise on safety and tolerability

    Measured by number of serious adverse effects related to the intervention

    Measured: Baseline to 3 years follow-up

  9. Long-term effects of exercise

    Long-term effects will be measured by all outcomes listed above, including number of serious adverse effects.

    Measured: Baseline to 3 years follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2013 (estimated)
  2. Study startFeb 2013
  3. Primary completionDec 2019
  4. Study completion5 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01796379
Sponsor's protocol ID
9378
Acronym
HITTS
Status last verified
Dec 2019
First submitted
18 Feb 2013
Last updated
9 Dec 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 22900793

  • 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.

    PubMed 26856221

  • 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.

    PubMed 30211027

  • 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.

    PubMed 37440977

  • 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.

    PubMed 32807179

  • 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.

    PubMed 32518655

  • 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.

    PubMed 32484261

  • 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.

    PubMed 30773030

Questions about this trial

What is this clinical trial studying?

A study testing High Intensity Interval Training and Moderate Training in people with Heart Transplant Recipients and Physical Fitness, run by Oslo University Hospital at 3 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Denmark, Norway, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect of exercise on peak oxygen uptake (time frame: Baseline to one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01796379, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2019; AzTrials last refreshed its copy on 7 Nov 2026.

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