Effect of Exercise After Heart Transplantation
TEX
Effect of High Intensity Interval-based Aerobic Exercise 1-8 Years After Heart Transplantation. 1 Year Follow Up.
1 other identifier
interventional
51
1 country
1
Brief Summary
This is a randomized controlled trial which will include approximately 50 heart transplant recipients 1-8 years after heart transplantation. The intervention and follow up period is 1 year. The primary purpose is to investigate if systematic, high intensity, interval-based aerobic exercise training results in a greater improvement of exercise capacity (measured by VO2peak) than previously shown in heart transplant recipients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2009
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
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 18, 2010
CompletedFirst Posted
Study publicly available on registry
March 23, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedFebruary 20, 2013
February 1, 2013
2 years
March 18, 2010
February 18, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Peak oxygen uptake (VO2peak)
Before and after the intervention period of 1 year
Secondary Outcomes (8)
Isokinetic muscle strength of quadriceps and hamstrings
Before and after the intervention period of 1 year
Quality of life measured by questionnaires
Before and after the intervention period of 1 year
Myocardial function measured by echocardiography
Before and after the intervention period of 1 year
Progression on coronary atherosclerosis measured by intra vascular ultrasound (IVUS)
Before and after the intervention period of 1 year
Vascular tone and compliance measured by tonometry
Before and after the intervention period of 1 year
- +3 more secondary outcomes
Study Arms (2)
Exercise
OTHERInterval-based aerobic exercise
Control
NO INTERVENTIONNo intervention other than regular follow up hospital visits
Interventions
High intensity interval-based aerobic exercise training. Duration: 1 year. Three 8-weeks supervised periods of physical training 3 times per week. Individual training 2 times per week between these periods.
Eligibility Criteria
You may qualify if:
- Norwegian heart transplanted patients \> 18 years of age
- years after heart transplantation
- Optimal medical treatment
- Stable condition
- Written informed consent
- Must have access to a physical therapist or personal trainer in their hometown
- Motivation for exercise
You may not qualify if:
- Unstable condition
- In need of revascularization or other invention
- Infections, open wounds or skin diseases
- Physical disabilities which prevent participation
- Other diseases, illnesses or conditions which contradict exercise
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oslo University Hospitallead
- Helse Sor-Ostcollaborator
Study Sites (1)
Department of Cardiology, Oslo University Hospital, Rikshospitalet
Oslo, 0027, Norway
Related Publications (4)
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: 22900793RESULTRustad LA, Nytroen K, Amundsen BH, Gullestad L, Aakhus S. One year of high-intensity interval training improves exercise capacity, but not left ventricular function in stable heart transplant recipients: a randomised controlled trial. Eur J Prev Cardiol. 2014 Feb;21(2):181-91. doi: 10.1177/2047487312469477. Epub 2012 Nov 26.
PMID: 23185084RESULTNytroen 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, 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: 32518655DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lars Gullestad, MD,PhD,Prof.
Oslo University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2010
First Posted
March 23, 2010
Study Start
October 1, 2009
Primary Completion
October 1, 2011
Study Completion
December 1, 2011
Last Updated
February 20, 2013
Record last verified: 2013-02