Heart TransplantationNCT02602834
Imminently Effect of Interval Training With High Intensity (HIT) After Heart Transplantation
A study testing interval training and moderate exercise in people with Heart Transplantation, run by Oslo University Hospital at 1 site in Norway.
Trial summary
High intensity Interval training (HIT) has repeatedly been documented to have superior positive effects on oxygen uptake and general physical health compared to continuous moderate exercise in healthy individuals and patients with heart disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Transplantation
- What is being tested?
- interval training and moderate exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteNorway
- Study dates
- May 2015to Nov 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1-10 years after heart transplantation
- Lives in Oslo or near Oslo
- Stable health condition
- Optimal medical treatment/ medication
- No limiting physical handicap
- Written consent
Show all 10Show fewer
- No verified heart disease
- Willing to preform the study
- Over 18 years
- Written consent
Who cannot join
- Under 1 year or over 10 year since HTx.
- Lives far from Oslo
- Unstable health condition
- Not optimal medical treatment and/ or medication
- Limiting physical handicap
- Under 18 years
- Not written consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes in Blood Measured Before, During and After Exercise in Heart Transplant Recipients. Imminently Effect of Interval Training With High Intensity Compared With Continuous Moderate Intensity
High intensity Interval training (HIT) has repeatedly been documented to have superior positive effects on oxygen uptake and general physical health compared to continuous moderate exercise in healthy individuals and patients with heart disease. Recently, the same effect has been shown in heart transplanted recipients. Which mechanisms that explains this difference is uncertain; the effect can be due to changes in the heart or changes in the peripheral tissue and muscles. To explore these mechanisms the investigators will in this study compare two different exercise modalities, and explore how different biomarkers change in blood, related to exercise.
Read the detailed description
15 heart transplanted recipients (and 5 healthy controls) will be included in the study. Each patient will have three study-days.
The study is designed to be a cross-over study. And randomisation will decide which training they will have som training session 1 and training session 2; Interval or continuous training.
Before starting the two training sessions they will measure oxygen uptake and baseline blood samples.
During each exercise session the patients will take blood samples during and after exercise.
After first study admission the patients will have a wash out period for 1 week until first training session, and another week until the last session.
- Conditions
- Heart Transplantation
- Being tested
- interval training, moderate exercise
- Keywords
- exercise test, biological markers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interval trainingOther
4 intervals with high intensity on treadmill, and approximately 3 minutes rest between intervals.
moderate exerciseOther
30 minutes (moderate intensity) aerobic exercise on treadmill without rest.
| Study group | Role | What they receive |
|---|---|---|
| HTx | Experimental | Heart transplant recipients n=15 Receives: Other: interval training; Other: moderate exercise |
| Control | Active comparator | Healthy controls n=5 Receives: Other: interval training; Other: moderate exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in crp with interval training compared to moderate training
Measured: 1 week
Changes in interleukin levels with interval training compared to moderate training
Measured: 1 week
Changes in ICAM levels with interval training compared to moderate training
Measured: 1 week
Changes in MiRNA levels with interval training compared to moderate training
Measured: 1 week
Secondary outcomes (3)
Questionnaire of quality of life
Measured: baseline
Oxygen uptake
V02 peak measured på exercise test on treadmill.
Measured: baseline
Questionnaire of physical activity
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study startMay 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Health Association
- Responsible party
- Principal investigator, Marianne Yardley, Oslo University Hospital
- Investigators
- Lars LG Gullestad, professor, Study director, OUS-Oslo university hospital rikshospitalet, cardiology department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02602834
- Sponsor's protocol ID
- 2015/97/REK sør-øst A
- Status last verified
- Nov 2016
- First submitted
- 6 Oct 2015
- Last updated
- 10 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Yardley M, Ueland T, Aukrust P, Michelsen A, Bjorkelund E, Gullestad L, Nytroen K. Immediate response in markers of inflammation and angiogenesis during exercise: a randomised cross-over study in heart transplant recipients. Open Heart. 2017 Nov 28;4(2):e000635. doi: 10.1136/openhrt-2017-000635. eCollection 2017.
PubMed 29225901
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Blood Measured Before, During and After Exercise in Heart Transplant Recipients. Imminently Effect of Interval Training With High Intensity Compared With Continuous Moderate Intensity
- ClinicalTrials.gov ID
- NCT02602834
- Acronym / sponsor ID
- 2015/97/REK sør-øst A
- Conditions
- Heart Transplantation
- Keywords
- exercise test, biological markers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Norwegian Health Association
- Study start
- May 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 11 Nov 2015 (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.
High intensity Interval training (HIT) has repeatedly been documented to have superior positive effects on oxygen uptake and general physical health compared to continuous moderate exercise in healthy individuals and patients with heart disease. Recently, the same effect has been shown in heart transplanted recipients. Which mechanisms that explains this difference is uncertain; the effect can be due to changes in the heart or changes in the peripheral tissue and muscles. To explore these mechanisms the investigators will in this study compare two different exercise modalities, and explore how different biomarkers change in blood, related to exercise.
Detailed description
15 heart transplanted recipients (and 5 healthy controls) will be included in the study. Each patient will have three study-days.
The study is designed to be a cross-over study. And randomisation will decide which training they will have som training session 1 and training session 2; Interval or continuous training.
Before starting the two training sessions they will measure oxygen uptake and baseline blood samples.
During each exercise session the patients will take blood samples during and after exercise.
After first study admission the patients will have a wash out period for 1 week until first training session, and another week until the last session.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HTx | Experimental | Other: interval training, Other: moderate exerciseHeart transplant recipients n=15 |
| Control | Active comparator | Other: interval training, Other: moderate exerciseHealthy controls n=5 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1-10 years after heart transplantation
- Lives in Oslo or near Oslo
- Stable health condition
- Optimal medical treatment/ medication
- No limiting physical handicap
Key exclusion criteria (7 listed)
- Under 1 year or over 10 year since HTx.
- Lives far from Oslo
- Unstable health condition
- Not optimal medical treatment and/ or medication
- Limiting physical handicap
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 training4 intervals with high intensity on treadmill, and approximately 3 minutes rest between intervals. | Other | Control, HTx |
| moderate exercise30 minutes (moderate intensity) aerobic exercise on treadmill without rest. | Other | Control, HTx |
Primary outcome
Changes in crp with interval training compared to moderate training
Time frame: 1 week
Changes in interleukin levels with interval training compared to moderate training
Time frame: 1 week
Changes in ICAM levels with interval training compared to moderate training
Time frame: 1 week
Changes in MiRNA levels with interval training compared to moderate training
Time frame: 1 week
3 secondary outcomes
Questionnaire of quality of life
Time frame: baseline
Oxygen uptake
Time frame: baseline
Questionnaire of physical activity
Time frame: baseline
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 10 Nov 2016.
- Derived from this study: PubMed 29225901Yardley M, Ueland T, Aukrust P, Michelsen A, Bjorkelund E, Gullestad L, Nytroen K. Immediate response in markers of inflammation and angiogenesis during exercise: a randomised cross-over study in heart transplant recipients. Open Heart. 2017 Nov 28;4(2):e000635. doi: 10.1136/openhrt-2017-000635. eCollection 2017.
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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 LG Gullestad, professor study director
OUS-Oslo university hospital rikshospitalet, cardiology department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing interval training and moderate 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 10 inclusion and 7 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 10 Nov 2016. 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.
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?
Changes in crp with interval training compared to moderate training (time frame: 1 week). The study lists 4 primary outcomes in all. 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 NCT02602834, which also lists 1 linked publication.
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 10 Nov 2016.