Breathing Training in Children, Adolescents and Young Adults with Tetralogy of Fallot after Total Surgical Repair

Not Applicable

• Conditions: Tetralogy of Fallot; Q21.3

• Registration Number: DRKS00011363
• Lead Sponsor: Deutsches Herzzentrum München

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-28
• Study Completion: 2019-04-23
• Results First Posted: 2021-03-18
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patients having Tetralogy of Fallot
Age between 8-25
No bronchial obstruction (FEV1/FVC: SDS>-1,645)

Exclusion Criteria

Change in medication within the last 3 month
Katheterization within the last 6 month
Heart-Surgery within the last 12 month
Planned surgery within the next 36 month
Severe left heart failure (NYHA IV)
Frequent arrhythmia (no HRV-measurement)
Pacemaker
Acute infected lungs

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in physical capacity after 6 month breathing training; the training is supervised by phone. Patients undergo a cardiopulmonary exercise test where the peak oxygen uptake is calculated. It is measured on the basic follow-up and 6 month later.

Secondary Outcome Measures

Name	Time	Method
cardiopulmonary exercise test: V/Q-Missmatch (VE/VCO2slope), <br>Pulmonary function: Lungenvolumina (TLC, FVC, FEV1)<br>NIRS: oxygenation in muscles<br>HRV: heart rate variability before and after exercise<br>Fitnessgram: trength and flexibility<br>Flexibility in thorax: impairement in flexibility<br>Health-realted quality of life: KINDL-R<br>Physical activity: MoMo-questionnaire<br>Labor: NT-proBNP<br>They are measured on the basic follow-up and 6 month later.