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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00011363
Enrollment
60
Registered
2017-06-28
Start date
2017-02-23
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Q21.3

Interventions

Group 1: Breathing-training is standardized by Coach2® Incentive spirometer-lungtrainer. Patients need to brath in deeply and long. If they reach the value they have to (scale on the device) they stop

Sponsors

Deutsches Herzzentrum München
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 25 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

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

Countries

Germany

Contacts

Public ContactJulia Hock

Deutsches Herzzentrum München

hock@dhm.mhn.de+498912183009

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026