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Inspiratory Muscle Training in Patients with Univentricular Heart after Palliative Fontan Operation

Inspiratory Muscle Training in Patients with Univentricular Heart after Palliative Fontan Operation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00010477
Enrollment
40
Registered
2016-05-10
Start date
2016-07-13
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

Q20

Interventions

Group 1: The inspiratory resistance training will be performed with the device POWERbreathe (Fa. GAIAM, Ltd.). Patients breathe through the device and feel resistance at inhalation. At the beginning

Sponsors

Deutsches Herzzentrum München
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Univentricular Heart Fontan physiology

Exclusion criteria

Exclusion criteria: Change in drug administration in the last 3 months Cardiac catheter examination in the last 6 months Heart surgery in the last 12 months Planned intervention in the near future Neuromuscular disease Moderate to severe ventricular dysfunction

Design outcomes

Primary

MeasureTime frame
Change in physical capacity after 6 months of supervised inspiratory training: Based on cardiopulmonary exercise tests the maximal oxygen uptake (peak VO2) will be evaluated at baseline and after 6 months.

Secondary

MeasureTime frame
Change in ventilation-perfusion mismatch: VE/VCO2 slope from a cardiopulmonary exercise test Changes in lung volumes (FVC, FEV1) at spirometry Change in quality of life: SF-36 quality of life (Questionary) Change in tissue oxygenation: near infrared spectroscopy Change in the autonomic nervous system: Heart rate variability In addition, those patients with ventilatory training will be examined again after 6 months of unsupervised training. Those patients randomized to the control group will receive supervised ventilatory training after their 6 months control, another evaluation after that 6 months of supervised training and a fourth evaluation after 6 months of unsupervised training.

Countries

Germany

Contacts

Public ContactCelina Fritz

Deutsches Herzzentrum München

fritz@dhm.mhn.de+49-89-1218-1652

Outcome results

None listed

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