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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02602834
Recruitment Status : Completed
First Posted : November 11, 2015
Last Update Posted : November 10, 2016
Sponsor:
Collaborator:
Norwegian Health Association
Information provided by (Responsible Party):
Marianne Yardley, 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.

Condition or disease Intervention/treatment Phase
Heart Transplantation Other: interval training Other: moderate exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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 Start Date : May 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HTx
Heart transplant recipients n=15
Other: interval training
4 intervals with high intensity on treadmill, and approximately 3 minutes rest between intervals.

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

Active Comparator: Control
Healthy controls n=5
Other: interval training
4 intervals with high intensity on treadmill, and approximately 3 minutes rest between intervals.

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02602834


Locations
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Norway
OUS- Rikshospitalet
Oslo, Norway, 0424
Sponsors and Collaborators
Oslo University Hospital
Norwegian Health Association
Investigators
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Study Director: Lars LG Gullestad, professor OUS-Oslo university hospital rikshospitalet, cardiology department
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marianne Yardley, MD, PhD candidate, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02602834    
Other Study ID Numbers: 2015/97/REK sør-øst A
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: November 10, 2016
Last Verified: November 2016
Keywords provided by Marianne Yardley, Oslo University Hospital:
exercise test
biological markers