Inspiratory Muscle Training in Patients with Univentricular Heart after Palliative Fontan Operatio
Not Applicable
- Conditions
- Q20Congenital malformations of cardiac chambers and connections
- Registration Number
- DRKS00010477
- Lead Sponsor
- Deutsches Herzzentrum München
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 42
Inclusion Criteria
Univentricular Heart
Fontan physiology
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Change in ventilation-perfusion mismatch: VE/VCO2 slope from a cardiopulmonary exercise test<br>Changes in lung volumes (FVC, FEV1) at spirometry<br>Change in quality of life: SF-36 quality of life (Questionary)<br>Change in tissue oxygenation: near infrared spectroscopy<br>Change in the autonomic nervous system: Heart rate variability<br><br>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. <br>