|
Main
|
|
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:
|
16 December 2017 |
|
Main ID: |
NCT02643810 |
|
Date of registration:
|
20/12/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Exercise Training in Adults With Corrected Tetralogy of Fallot
|
|
Scientific title:
|
Influence of Different Types of Exercise Training on Selected Cardiovascular Parameters in Adult Individuals With Corrected Tetralogy of Fallot |
|
Date of first enrolment:
|
June 2015 |
|
Target sample size:
|
27 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02643810 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Slovenia
| | | | | | | |
|
Contacts
|
|
Name:
|
Borut Jug, MD, Ph.D. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University Medical Centre Ljubljana, Slovenia |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- congenital tetralogy of Fallot surgically corrected in childhood
Exclusion Criteria:
- contraindications for exercise training,
- uncontrolled dysrhythmias,
- uncontrolled heart failure (New York Heart Association (NYHA) stage IV),
- unstable coronary or other arterial disease,
- intellectual development disorder,
- pregnancy.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Tetralogy of Fallot
|
|
Intervention(s)
|
|
Other: Exercise training
|
|
Primary Outcome(s)
|
|
Change of maximal oxygen uptake during exercise, measured in ml/kg/min
[Time Frame: 3 months]
|
|
Secondary Outcome(s)
|
|
Change of the arterial stiffness coefficient
[Time Frame: 3 months]
|
|
Change of the heart rate variability
[Time Frame: 3 months]
|
|
Change of the ECG waves
[Time Frame: 3 months]
|
|
Change of the value of blood D-dimer, measured in microg/l
[Time Frame: 3 months]
|
|
Change of from-the-questionnaire-obtained quality of life, measured in points
[Time Frame: 3 months]
|
|
Change of the value of blood N terminal-proBNP, measured in ng/l
[Time Frame: 3 months]
|
|
Change of flow-mediated dilatation of the brachial artery, measured in %
[Time Frame: 3 months]
|
|
Change in the result of the 6-minute walking test, measured in metres
[Time Frame: 3 months]
|
|
Change of the value of blood fibrinogen, measured in g/l
[Time Frame: 3 months]
|
|
Secondary ID(s)
|
|
UKCLRehab0012015
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|