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Long Term Effect of High-intensity Training 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. Identifier: NCT02213770
Recruitment Status : Completed
First Posted : August 11, 2014
Last Update Posted : January 25, 2016
Norwegian Health Association
Information provided by (Responsible Party):
Marianne Yardley, Oslo University Hospital

Brief Summary:

High-intensity training (HIT) has repeatedly been documented to have superior positive effects compared to moderate exercise in patients with coronary heart disease and heart failure. Since heart transplant recipients (HTx), have a denervated heart with different respond to exercise, HIT has previously not been introduced among these patients. Rikshospitalet carried out a RCT to investigate this (the TEX study 2009-2012), and found that this form of exercise also was highly effective and safe in long term HTx with clinically significant improvement in VO2peak, muscular exercise capasity, general HRQoL, and even slower progression of CAV (coronary allograft vasculopathy). Based on these findings we ask the following questions in this follow-up study:

  1. Would the effect on VO2peak, HRQoL,muscle capacity and CAV obtained during the study period continue during long term follow up (5 years)?
  2. Is the intervention group more physical active after HIT compared to the control group?

Condition or disease
Heart Transplant Recipients

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Study Type : Observational
Actual Enrollment : 41 participants
Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Study Start Date : August 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

Intervention group
Group that followed high- intensity interval training program in TEX study.
Control group
Followed up on a regular basis for HTx recipients in Norway.

Primary Outcome Measures :
  1. mean VO2peak in the intervention group and control group [ Time Frame: 5 years after start of inclusion in RCT (TEX). One measurment. ]
    We will use the same test protocol as the TEX- study.

Secondary Outcome Measures :
  1. How many has progression of cardiac allograft vasculopathy in the intervention group and control group. [ Time Frame: 5 years after inclusion in RCT (TEX study). ]
    Progression of vasculopathy will be studied with IVUS technique, and compared with IVUS pictures from TEX.

  2. Mean muscle capacity in the intervention group and control group. [ Time Frame: 5 years after inclusion in RCT, TEX study. ]
  3. Quality of life [ Time Frame: 5 years after inclusion in TEX- study. ]
    We will use validated questionnaires to estimate quality of life and to evaluate depression.

  4. Difference in activity level between groups [ Time Frame: 5 years after inclusion i RCT, TEX study. ]
    To estimate activity the study population will fill out a validated questionnaire about physical activity, and they will wear a physical activity monitor at home for one week.

Biospecimen Retention:   Samples Without DNA

Blodsamples from the patients will be studied:

Standard samples: RBC, WBC, plates, CRP, kreatinin, urea, liver tests, thyorid gland tests, lipid profile, fasting- glucose og hba1c, Pro BNP, troponin T, uric acid.

Supplement: Inflammation cytokines/chemokines such as TNF alfa, sTNFR2 og IL-6, IL-10, MCP-1 og IL-8. Growth factors and inhibitors for innervation. Markers for endothelial function; endotelin and von- Willebrand faktor and anti- trombotic factors; fibrinogen, plasminogen activator inhibitor-1.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The TEX population.

Inclusion Criteria:

  • stable situation
  • optimal medical treatment
  • written concent

Exclusion Criteria:

  • unstable situation,
  • infections (open wounds or skin diseases),
  • physical conditions that prevents participation,
  • or other injuries/ diseases who are contraindicated with training.

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 identifier (NCT number): NCT02213770

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OUS- Rikshospitalet
Oslo, Norway, 0424
Sponsors and Collaborators
Oslo University Hospital
Norwegian Health Association
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Study Director: Lars Gullestad, professor OUS- kardiologisk avdeling

Publications of Results:
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Responsible Party: Marianne Yardley, Cand med, Oslo University Hospital Identifier: NCT02213770     History of Changes
Other Study ID Numbers: 2014/872/REK sør-øst C
First Posted: August 11, 2014    Key Record Dates
Last Update Posted: January 25, 2016
Last Verified: January 2016