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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 1 February 2016
Main ID:  NCT02213770
Date of registration: 08/08/2014
Prospective Registration: No
Primary sponsor: Oslo University Hospital
Public title: Long Term Effect of High-intensity Training After Heart Transplantation
Scientific title:
Date of first enrolment: August 2014
Target sample size: 41
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02213770
Study type:  Observational
Study design:  Observational Model: Case-Crossover, Time Perspective: Cross-Sectional  
Phase:  N/A
Countries of recruitment
Norway
Contacts
Name:     Lars Gullestad, professor
Address: 
Telephone:
Email:
Affiliation:  OUS- kardiologisk avdeling
Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Heart Transplant Recipients
Intervention(s)
Primary Outcome(s)
mean VO2peak in the intervention group and control group [Time Frame: 5 years after start of inclusion in RCT (TEX). One measurment.]
Secondary Outcome(s)
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).]
Quality of life [Time Frame: 5 years after inclusion in TEX- study.]
Difference in activity level between groups [Time Frame: 5 years after inclusion i RCT, TEX study.]
Mean muscle capacity in the intervention group and control group. [Time Frame: 5 years after inclusion in RCT, TEX study.]
Secondary ID(s)
2014/872/REK sør-øst C
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Norwegian Health Association
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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