Heart TransplantationPhase 2TEXNCT01091194
Effect of Exercise After Heart Transplantation
A Phase 2 study testing Interval-based aerobic exercise in people with Heart Transplantation, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Transplantation
- What is being tested?
- Interval-based aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2009to Dec 2011
- Phase
- Phase 2
- 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
- Norwegian heart transplanted patients > 18 years of age
- 1-8 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of Cardiology, Oslo University Hospital, Rikshospitalet
Oslo, 0027
About this study
Official title: Effect of High Intensity Interval-based Aerobic Exercise 1-8 Years After Heart Transplantation. 1 Year Follow Up.
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.
- Conditions
- Heart Transplantation
- Being tested
- Interval-based aerobic exercise
- Keywords
- Heart Transplantation, Aerobic Exercise, Exercise, Physical, Exercise Test, Treadmill Test, VO2 peak, Muscle Strength, Quality of Life, Reinnervation, Heart Rate, Myocardial Function
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interval-based aerobic exerciseOther
Also called physical activity, fitness
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Other | Interval-based aerobic exercise Receives: Other: Interval-based aerobic exercise |
| Control | No intervention | No intervention other than regular follow up hospital visits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak oxygen uptake (VO2peak)
Measured: Before and after the intervention period of 1 year
Secondary outcomes (8)
Isokinetic muscle strength of quadriceps and hamstrings
Measured: Before and after the intervention period of 1 year
Quality of life measured by questionnaires
Measured: Before and after the intervention period of 1 year
Myocardial function measured by echocardiography
Measured: Before and after the intervention period of 1 year
Progression on coronary atherosclerosis measured by intra vascular ultrasound (IVUS)
Measured: Before and after the intervention period of 1 year
Vascular tone and compliance measured by tonometry
Measured: Before and after the intervention period of 1 year
Regular blood screening, lipid profile, inflammatory status, nerve growth factor, biochemical markers for endothelial function, prothrombotic factor, factors connected to vascularization: NT-proBNP and gene expression analysis.
Measured: Before and after the intervention period of 1 year
Analysis of isolated muscle cells from myocardial biopsy
Measured: Before and after the intervention period of 1 year
Reinnervation as judged by autonomic nervous control (Heart Rate Variability)
Measured: Before and after the intervention period of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2010 (estimated)
- Study startOct 2009
- Primary completionOct 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heart TransplantationStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Sor-Ost
- Responsible party
- Sponsor
- Investigators
- Lars Gullestad, MD,PhD,Prof., Study director, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01091194
- Sponsor's protocol ID
- 10920
- Acronym
- TEX
- Status last verified
- Feb 2013
- First submitted
- 18 Mar 2010
- Last updated
- 20 Feb 2013
- Results posted
- No
- Data monitoring committee
- 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 22900793Rustad 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.
PubMed 23185084Nytroen 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.
PubMed 22659939Nytroen 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Intensity Interval-based Aerobic Exercise 1-8 Years After Heart Transplantation. 1 Year Follow Up.
- ClinicalTrials.gov ID
- NCT01091194
- Acronym / sponsor ID
- TEX / 10920
- Conditions
- Heart Transplantation
- Keywords
- Heart Transplantation, Aerobic Exercise, Exercise, Physical, Exercise Test, Treadmill Test, VO2 peak, Muscle Strength, Quality of Life
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Helse Sor-Ost
- Study start
- Oct 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 23 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Other | Other: Interval-based aerobic exerciseInterval-based aerobic exercise |
| Control | No intervention | –No intervention other than regular follow up hospital visits |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Norwegian heart transplanted patients > 18 years of age
- 1-8 years after heart transplantation
- Optimal medical treatment
- Stable condition
- Written informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interval-based aerobic exerciseAlso: physical activity, fitnessHigh 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. | Other | Exercise |
Primary outcome
Peak oxygen uptake (VO2peak)
Time frame: Before and after the intervention period of 1 year
8 secondary outcomes
Isokinetic muscle strength of quadriceps and hamstrings
Time frame: Before and after the intervention period of 1 year
Quality of life measured by questionnaires
Time frame: Before and after the intervention period of 1 year
Myocardial function measured by echocardiography
Time frame: Before and after the intervention period of 1 year
Progression on coronary atherosclerosis measured by intra vascular ultrasound (IVUS)
Time frame: Before and after the intervention period of 1 year
Vascular tone and compliance measured by tonometry
Time frame: Before and after the intervention period of 1 year
Regular blood screening, lipid profile, inflammatory status, nerve growth factor, biochemical markers for endothelial function, prothrombotic factor, factors connected to vascularization: NT-proBNP and gene expression analysis.
Time frame: Before and after the intervention period of 1 year
Analysis of isolated muscle cells from myocardial biopsy
Time frame: Before and after the intervention period of 1 year
Reinnervation as judged by autonomic nervous control (Heart Rate Variability)
Time frame: Before and after the intervention period of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2013.
- Results publication: PubMed 22900793Nytroen 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.
- Results publication: PubMed 23185084Rustad 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.
- Results publication: PubMed 22659939Nytroen 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.
- Derived from this study: PubMed 32518655Nytroen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars Gullestad, MD,PhD,Prof. study director
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Interval-based aerobic exercise in people with Heart Transplantation, run by Oslo University Hospital at 1 site in Norway.
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 7 inclusion and 5 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 20 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Peak oxygen uptake (VO2peak) (time frame: Before and after the intervention period of 1 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 NCT01091194, which also lists 4 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 20 Feb 2013.