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

  • Norway
      • 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
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.

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

Oslo University Hospital

Collaborators

Norwegian Health Association

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.

General Publications

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.

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