Long Term Effect of High-intensity Training After Heart Transplantation

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Oslo University Hospital
Sponsor:
Collaborator:
Norwegian Health Association
Information provided by (Responsible Party):
Marianne Yardley, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT02213770
First received: August 8, 2014
Last updated: NA
Last verified: August 2014
History: No changes posted
  Purpose

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
Heart Transplant Recipients

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Cross-Sectional

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • mean VO2peak in the intervention group and control group [ Time Frame: 5 years after start of inclusion in RCT (TEX). One measurment. ] [ Designated as safety issue: No ]
    We will use the same test protocol as the TEX- study.


Secondary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]
    Progression of vasculopathy will be studied with IVUS technique, and compared with IVUS pictures from TEX.

  • Mean muscle capacity in the intervention group and control group. [ Time Frame: 5 years after inclusion in RCT, TEX study. ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 5 years after inclusion in TEX- study. ] [ Designated as safety issue: No ]
    We will use validated questionnaires to estimate quality of life and to evaluate depression.

  • Difference in activity level between groups [ Time Frame: 5 years after inclusion i RCT, TEX study. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 48
Study Start Date: August 2014
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The TEX population.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02213770

Contacts
Contact: Marianne Yardley, Cand med marianya@medisin.uio.no

Locations
Norway
OUS- Rikshospitalet Recruiting
Oslo, Norway, 0424
Contact: Marianne Yardley, cand med       marianya@medisin.uio.no   
Sponsors and Collaborators
Oslo University Hospital
Norwegian Health Association
Investigators
Study Director: Lars Gullestad, professor OUS- kardiologisk avdeling
  More Information

Publications:
Responsible Party: Marianne Yardley, Cand med, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02213770     History of Changes
Other Study ID Numbers: 2014/872/REK sør-øst C
Study First Received: August 8, 2014
Last Updated: August 8, 2014
Health Authority: Norway: Regional Ethics Commitee

ClinicalTrials.gov processed this record on October 21, 2014