Imminently Effect of Interval Training With High Intensity (HIT) After Heart Transplantation

Not Applicable

Completed

• Conditions: Heart Transplantation

• Registration Number: NCT02602834
• Lead Sponsor: Oslo University Hospital

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.

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-10-06
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Study First Submitted QC: 2015-11-10
• Study First Posted: 2015-11-11
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-09
• Last Update Posted: 2016-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Changes in crp with interval training compared to moderate training	1 week
Changes in interleukin levels with interval training compared to moderate training	1 week
Changes in MiRNA levels with interval training compared to moderate training	1 week
Changes in ICAM levels with interval training compared to moderate training	1 week

Secondary Outcome Measures

Name	Time	Method
Questionnaire of physical activity	baseline
Questionnaire of quality of life	baseline
Oxygen uptake	baseline	V02 peak measured på exercise test on treadmill.

Trial Locations

Locations (1)

OUS- Rikshospitalet; 🇳🇴 Oslo, Norway