Clinical trial NCT02602834: Imminently Effect of Interval Training With High Intensity (HIT) After Heart Transplantation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Transplantation
Keywords: exercise test
biological markers
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian Health Association
First posted: 2015-11-11
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in crp with interval training compared to moderate training
timeFrame: 1 week
measure: Changes in interleukin levels with interval training compared to moderate training
timeFrame: 1 week
measure: Changes in ICAM levels with interval training compared to moderate training
timeFrame: 1 week
measure: Changes in MiRNA levels with interval training compared to moderate training
timeFrame: 1 week
Secondary outcomes:
measure: Questionnaire of quality of life
timeFrame: baseline
measure: Oxygen uptake
timeFrame: baseline
measure: Questionnaire of physical activity
timeFrame: baseline
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: OUS- Rikshospitalet
Study officials:
affiliation: OUS-Oslo university hospital rikshospitalet, cardiology department
name: Lars LG Gullestad, professor
role: STUDY_DIRECTOR
References:
citation: 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.