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Completed

NCT Number: NCT02602834

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

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.

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Key information

Conditions

Heart Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

OUS- Rikshospitalet

Oslo, 0424, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interval training

Other

4 intervals with high intensity on treadmill, and approximately 3 minutes rest between intervals.

Moderate exercise

Other

30 minutes (moderate intensity) aerobic exercise on treadmill without rest.

Primary outcomes

  1. Changes in crp with interval training compared to moderate training

    Time frame: 1 week

  2. Changes in interleukin levels with interval training compared to moderate training

    Time frame: 1 week

  3. Changes in ICAM levels with interval training compared to moderate training

    Time frame: 1 week

  4. Changes in MiRNA levels with interval training compared to moderate training

    Time frame: 1 week

Secondary outcomes

  1. Questionnaire of quality of life

    Time frame: baseline

  2. Oxygen uptake

    Time frame: baseline

    V02 peak measured på exercise test on treadmill.

  3. Questionnaire of physical activity

    Time frame: baseline

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Norwegian Health Association

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Nov 11, 2015
Registry last updated
Nov 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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