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Completed

NCT Number: NCT01914406

High-intensity Interval Training Versus Moderate Continuous Training in Heart Transplant Recipients.

The aim of this study was to examine the effects of high intensity aerobic interval training (AIT) versus moderate continuous training (CON) in heart transplant recipients.

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Key information

Conditions

Heart Transplant Recipients

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiac Rehabilitation, Bispebjerg University Hospital

Copenhagen, 2400, Denmark

About this study

Clinically stable heart transplant recipients > 12 month or more after HTx, age > 18 years, willing and capable of giving written informed consent for study participation and anticipated to be able to participate in the study for 12 months were included from the Heart Centre, Rigshospitalet, Copenhagen University Hospital.

Patients were excluded due to unstable condition or postoperative complications, recent severe rejection episodes (>H1R < 3 month), physical disabilities which prevent participation and re-transplantation or multi-organtransplantation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

-stable Heart transplant recipients > 12 month or more after HTx, age > 18 years,< 80. willing and capable of giving written informed consent for study participation.

Exclusion criteria

unstable condition postoperative complications, recent severe rejection episodes (>H1R < 3 month), re-transplantation or multi-organtransplantation.

Treatment and study plan

high intense interval training

Other

Each AIT session consisted a 10 minute warm-up period followed by 16 minutes of interval training consisting of intervals of 4-3-2 and 1 minutes duration at 85-95% of their peak capacity separated by 2-4 min active rest.

continuous moderate training

Other

Continued exercise 45 min.

Primary outcomes

  1. VO2peak

    Time frame: baseline test (inclusion), follow-up 1(3 month), follow-up 2 (8 month), follow-up 3 (11 month).

    baseline test before randomization

    • follow-up after 12 weeks of exercise
    • follow-up after 5 month washout.
    • follow-up after second 12 weeks period of exercise.

Secondary outcomes

  1. Endothelial function (endoPAT)

    Time frame: baseline test (inclusion), follow-up 1(3 month), follow-up 2 (8 month), follow-up 3 (11 month).

    After the release of the cuff the hyperemic response was recorded and the reactive hyperemia index (RHI) was calculated automatic independent of operator. (endoPAT)

  2. Quality of Life (QoL)SF-36

    Time frame: baseline test (inclusion), follow-up 1(3 month), follow-up 2 (8 month), follow-up 3 (11 month).

    SF-36, information on Quality of Life

  3. HADS-a, HADS-d anxiety and depression

    Time frame: baseline test (inclusion), follow-up 1(3 month), follow-up 2 (8 month), follow-up 3 (11 month).

    Symptoms of anxiety and depression measured by the Hospital Anxiety and Depression Scale (HADS).

  4. Bloodsamples/biomarkers.

    Time frame: baseline test (inclusion), follow-up 1(3 month), follow-up 2 (8 month), follow-up 3 (11 month).

    Samples cooled on ice, centrifuged for 10 minutes and the plasma transferred to microtubes and stored at -80°C. Biomarkers analysed at department of biomedicine at University of Copenhagen.

  5. augmentation index (AI), endoPAT

    Time frame: baseline test (inclusion), follow-up 1(3 month), follow-up 2 (8 month), follow-up 3 (11 month).

    Augmentation index (AI)derived from pulse wave analyses and is a measure of arterial stiffness, (EndoPAT).

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Registry information

Official study title

High-intensity Interval Training Versus Moderate Continuous Training in Heart Transplant Recipients With Impaired Chronotropic Response: A Randomized Controlled Crossover Trial.

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 2, 2013
Registry last updated
Oct 24, 2023

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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