Imminently Effect of Interval Training With High Intensity (HIT) After Heart Transplantation
November 9, 2016 updated by: Marianne Yardley, Oslo University Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
19
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Oslo, Norway, 0424
- OUS- Rikshospitalet
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria (HTx):
- 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
Inclusion healthy control:
- No verified heart disease
- Willing to preform the study
- Over 18 years
- Written consent
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: HTx
Heart transplant recipients n=15
|
4 intervals with high intensity on treadmill, and approximately 3 minutes rest between intervals.
30 minutes (moderate intensity) aerobic exercise on treadmill without rest.
|
|
Active Comparator: Control
Healthy controls n=5
|
4 intervals with high intensity on treadmill, and approximately 3 minutes rest between intervals.
30 minutes (moderate intensity) aerobic exercise on treadmill without rest.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Changes in crp with interval training compared to moderate training
Time Frame: 1 week
|
1 week
|
|
Changes in interleukin levels with interval training compared to moderate training
Time Frame: 1 week
|
1 week
|
|
Changes in ICAM levels with interval training compared to moderate training
Time Frame: 1 week
|
1 week
|
|
Changes in MiRNA levels with interval training compared to moderate training
Time Frame: 1 week
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Questionnaire of quality of life
Time Frame: baseline
|
baseline
|
|
|
Oxygen uptake
Time Frame: baseline
|
V02 peak measured på exercise test on treadmill.
|
baseline
|
|
Questionnaire of physical activity
Time Frame: baseline
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Lars LG Gullestad, professor, OUS-Oslo university hospital rikshospitalet, cardiology department
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2015
Primary Completion (Actual)
November 1, 2015
Study Completion (Actual)
November 1, 2015
Study Registration Dates
First Submitted
October 6, 2015
First Submitted That Met QC Criteria
November 10, 2015
First Posted (Estimate)
November 11, 2015
Study Record Updates
Last Update Posted (Estimate)
November 10, 2016
Last Update Submitted That Met QC Criteria
November 9, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2015/97/REK sør-øst A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.