Long Term Effect of High-intensity Training After Heart Transplantation
1 other identifier
observational
41
1 country
1
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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 8, 2014
CompletedFirst Posted
Study publicly available on registry
August 11, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedJanuary 25, 2016
January 1, 2016
1.3 years
August 8, 2014
January 22, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
mean VO2peak in the intervention group and control group
We will use the same test protocol as the TEX- study.
5 years after start of inclusion in RCT (TEX). One measurment.
Secondary Outcomes (4)
How many has progression of cardiac allograft vasculopathy in the intervention group and control group.
5 years after inclusion in RCT (TEX study).
Mean muscle capacity in the intervention group and control group.
5 years after inclusion in RCT, TEX study.
Quality of life
5 years after inclusion in TEX- study.
Difference in activity level between groups
5 years after inclusion i RCT, TEX study.
Study Arms (2)
Intervention group
Group that followed high- intensity interval training program in TEX study.
Control group
Followed up on a regular basis for HTx recipients in Norway.
Eligibility Criteria
The TEX population.
You may qualify if:
- stable situation
- optimal medical treatment
- written concent
You may not qualify if:
- unstable situation,
- infections (open wounds or skin diseases),
- physical conditions that prevents participation,
- or other injuries/ diseases who are contraindicated with training.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oslo University Hospitallead
- Norwegian Health Associationcollaborator
Study Sites (1)
OUS- Rikshospitalet
Oslo, Oslo County, 0424, Norway
Related Publications (4)
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.
PMID: 21765276RESULTNytroen 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.
PMID: 22659939RESULTNytroen 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.
PMID: 23906899RESULTNytroen 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: 22900793RESULT
Biospecimen
Blodsamples from the patients will be studied: Standard samples: RBC, WBC, plates, CRP, kreatinin, urea, liver tests, thyorid gland tests, lipid profile, fasting- glucose og hba1c, Pro BNP, troponin T, uric acid. Supplement: Inflammation cytokines/chemokines such as TNF alfa, sTNFR2 og IL-6, IL-10, MCP-1 og IL-8. Growth factors and inhibitors for innervation. Markers for endothelial function; endotelin and von- Willebrand faktor and anti- trombotic factors; fibrinogen, plasminogen activator inhibitor-1.
Study Officials
- STUDY DIRECTOR
Lars Gullestad, professor
OUS- kardiologisk avdeling
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Cand med
Study Record Dates
First Submitted
August 8, 2014
First Posted
August 11, 2014
Study Start
August 1, 2014
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
January 25, 2016
Record last verified: 2016-01