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TEX: Effect of Exercise After Heart Transplantation

Sponsor
Oslo University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01091194
Collaborator
Helse Sor-Ost (Other)
51
Enrollment
1
Location
2
Arms
26
Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Interval-based aerobic exercise
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
51 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of High Intensity Interval-based Aerobic Exercise 1-8 Years After Heart Transplantation. 1 Year Follow Up.
Study Start Date :
Oct 1, 2009
Actual Primary Completion Date :
Oct 1, 2011
Actual Study Completion Date :
Dec 1, 2011

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Peak oxygen uptake (VO2peak) [Before and after the intervention period of 1 year]

    Secondary Outcome Measures

    1. Isokinetic muscle strength of quadriceps and hamstrings [Before and after the intervention period of 1 year]

    2. Quality of life measured by questionnaires [Before and after the intervention period of 1 year]

    3. Myocardial function measured by echocardiography [Before and after the intervention period of 1 year]

    4. Progression on coronary atherosclerosis measured by intra vascular ultrasound (IVUS) [Before and after the intervention period of 1 year]

    5. Vascular tone and compliance measured by tonometry [Before and after the intervention period of 1 year]

    6. 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. [Before and after the intervention period of 1 year]

    7. Analysis of isolated muscle cells from myocardial biopsy [Before and after the intervention period of 1 year]

    8. Reinnervation as judged by autonomic nervous control (Heart Rate Variability) [Before and after the intervention period of 1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Cardiology, Oslo University Hospital, Rikshospitalet Oslo Norway 0027

    Sponsors and Collaborators

    • Oslo University Hospital
    • Helse Sor-Ost

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Oslo University Hospital
    ClinicalTrials.gov Identifier:
    NCT01091194
    Other Study ID Numbers:
    • 10920
    First Posted:
    Mar 23, 2010
    Last Update Posted:
    Feb 20, 2013
    Last Verified:
    Feb 1, 2013
    Keywords provided by Oslo University Hospital
    Heart Transplantation
    Aerobic Exercise
    Exercise, Physical
    Exercise Test
    Treadmill Test
    VO2 peak
    Muscle Strength
    Quality of Life
    Reinnervation
    Heart Rate
    Myocardial Function

    Study Results

    No Results Posted as of Feb 20, 2013