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Completed

NCT Number: NCT02213770

Long Term Effect of High-intensity Training After Heart Transplantation

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?

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Key information

Conditions

Heart Transplant Recipients

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

OUS- Rikshospitalet

Oslo, 0424, Norway

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Norwegian Health Association

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 11, 2014
Registry last updated
Jan 25, 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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