Clinical trial NCT02213770: Long Term Effect of High-intensity Training After Heart Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Transplant Recipients
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian Health Association
First posted: 2014-08-11
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The TEX population.

Brief summary: High-intensity training (HIT) has repeatedly been documented to have superior positive effects compared to moderate exercise in patients with coronary heart disease and heart failure. Since heart transplant recipients (HTx), have a denervated heart with different respond to exercise, HIT has previously not been introduced among these patients. Rikshospitalet carried out a RCT to investigate this (the TEX study 2009-2012), and found that this form of exercise also was highly effective and safe in long term HTx with clinically significant improvement in VO2peak, muscular exercise capasity, general HRQoL, and even slower progression of CAV (coronary allograft vasculopathy). Based on these findings we ask the following questions in this follow-up study:

1. Would the effect on VO2peak, HRQoL,muscle capacity and CAV obtained during the study period continue during long term follow up (5 years)?
2. Is the intervention group more physical active after HIT compared to the control group?


Eligibility criteria: Inclusion Criteria:

* stable situation
* optimal medical treatment
* written concent

Exclusion Criteria:

* unstable situation,
* infections (open wounds or skin diseases),
* physical conditions that prevents participation,
* or other injuries/ diseases who are contraindicated with training.

Primary outcomes:
measure: mean VO2peak in the intervention group and control group
timeFrame: 5 years after start of inclusion in RCT (TEX). One measurment.
Secondary outcomes:
measure: How many has progression of cardiac allograft vasculopathy in the intervention group and control group.
timeFrame: 5 years after inclusion in RCT (TEX study).
measure: Mean muscle capacity in the intervention group and control group.
timeFrame: 5 years after inclusion in RCT, TEX study.
measure: Quality of life
timeFrame: 5 years after inclusion in TEX- study.
measure: Difference in activity level between groups
timeFrame: 5 years after inclusion i RCT, TEX study.
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: OUS- Rikshospitalet
Study officials:
affiliation: OUS- kardiologisk avdeling
name: Lars Gullestad, professor
role: STUDY_DIRECTOR
References:
citation: Nytroen K, Myers J, Chan KN, Geiran OR, Gullestad L. Chronotropic responses to exercise in heart transplant recipients: 1-yr follow-up. Am J Phys Med Rehabil. 2011 Jul;90(7):579-88. doi: 10.1097/PHM.0b013e31821f711d.
citation: Nytroen K, Rustad LA, Gude E, Hallen J, Fiane AE, Rolid K, Holm I, Aakhus S, Gullestad L. Muscular exercise capacity and body fat predict VO(2peak) in heart transplant recipients. Eur J Prev Cardiol. 2014 Jan;21(1):21-9. doi: 10.1177/2047487312450540. Epub 2012 Jun 1.
citation: Nytroen K, Rustad LA, Erikstad I, Aukrust P, Ueland T, Lekva T, Gude E, Wilhelmsen N, Hervold A, Aakhus S, Gullestad L, Arora S. Effect of high-intensity interval training on progression of cardiac allograft vasculopathy. J Heart Lung Transplant. 2013 Nov;32(11):1073-80. doi: 10.1016/j.healun.2013.06.023. Epub 2013 Jul 29.
citation: 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.