Effect of Exercise After Heart Transplantation (TEX)

February 18, 2013 updated by: Oslo University Hospital

Effect of High Intensity Interval-based Aerobic Exercise 1-8 Years After Heart Transplantation. 1 Year Follow Up.

This is a randomized controlled trial which will include approximately 50 heart transplant recipients 1-8 years after heart transplantation. The intervention and follow up period is 1 year. The primary purpose is to investigate if systematic, high intensity, interval-based aerobic exercise training results in a greater improvement of exercise capacity (measured by VO2peak) than previously shown in heart transplant recipients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Phase 2

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, 0027
        • Department of Cardiology, Oslo University Hospital, 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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Norwegian heart transplanted patients > 18 years of age
  • 1-8 years after heart transplantation
  • Optimal medical treatment
  • Stable condition
  • Written informed consent
  • Must have access to a physical therapist or personal trainer in their hometown
  • Motivation for exercise

Exclusion Criteria:

  • Unstable condition
  • In need of revascularization or other invention
  • Infections, open wounds or skin diseases
  • Physical disabilities which prevent participation
  • Other diseases, illnesses or conditions which contradict exercise

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Exercise
Interval-based aerobic exercise
Other: Interval-based aerobic exercise
High intensity interval-based aerobic exercise training. Duration: 1 year. Three 8-weeks supervised periods of physical training 3 times per week. Individual training 2 times per week between these periods.
Other Names:
  • physical activity, fitness
No Intervention: Control
No intervention other than regular follow up hospital visits

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Peak oxygen uptake (VO2peak)
Time Frame: Before and after the intervention period of 1 year
Before and after the intervention period of 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Isokinetic muscle strength of quadriceps and hamstrings
Time Frame: Before and after the intervention period of 1 year
Before and after the intervention period of 1 year
Quality of life measured by questionnaires
Time Frame: Before and after the intervention period of 1 year
Before and after the intervention period of 1 year
Myocardial function measured by echocardiography
Time Frame: Before and after the intervention period of 1 year
Before and after the intervention period of 1 year
Progression on coronary atherosclerosis measured by intra vascular ultrasound (IVUS)
Time Frame: Before and after the intervention period of 1 year
Before and after the intervention period of 1 year
Vascular tone and compliance measured by tonometry
Time Frame: Before and after the intervention period of 1 year
Before and after the intervention period of 1 year
Regular blood screening, lipid profile, inflammatory status, nerve growth factor, biochemical markers for endothelial function, prothrombotic factor, factors connected to vascularization: NT-proBNP and gene expression analysis.
Time Frame: Before and after the intervention period of 1 year
Before and after the intervention period of 1 year
Analysis of isolated muscle cells from myocardial biopsy
Time Frame: Before and after the intervention period of 1 year
Before and after the intervention period of 1 year
Reinnervation as judged by autonomic nervous control (Heart Rate Variability)
Time Frame: Before and after the intervention period of 1 year
Before and after the intervention period of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

Helse Sor-Ost

Investigators

  • Study Director: Lars Gullestad, MD,PhD,Prof., Oslo University Hospital

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

October 1, 2009

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

March 18, 2010

First Submitted That Met QC Criteria

March 22, 2010

First Posted (Estimate)

March 23, 2010

Study Record Updates

Last Update Posted (Estimate)

February 20, 2013

Last Update Submitted That Met QC Criteria

February 18, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 10920

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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