Physiological health assessment in adults with congenital heart defect (ACHD) - exercise, fitness, stress, sleep and blood vessels
Recruiting
- Conditions
- Q23Q22Q21Q25Q26Q20Q24Q27Q28Congenital malformations of aortic and mitral valves
- Registration Number
- DRKS00032675
- Lead Sponsor
- ehrstuhl für Präventive Pädiatrie der Technischen Universität München
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 468
Inclusion Criteria
Presence of congenital heart defect (must be mild, moderate, or complex by ACC criteria)
- NYHA class I and II
Exclusion Criteria
- Cognitive impairments that prevent patients from understanding tasks
- Taking medication, with chronotropic, dromotropic and/or bathmotropic effects
- Cardiac decompensation
- Pacemaker
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The difference in both objective and subjective stress levels between ACHD and apparently healthy controls. The objective stress is measured by using a wearable (heart rate variability). Subjective stress is taken from the questionnaire (Stress and Coping Inventory). All tests, data and the distribution of the wearable are done in patients on a routine examination day at the German Heart Center.
- Secondary Outcome Measures
Name Time Method - Difference in sleep quality and sleep phases between ACHD and control subjects.<br>- Difference in objective as well as subjective stress perception between ACHD and control subjects.<br>- Correlation between subjective stress perception and measured stress level.<br>- Correlation between maximum oxygen uptake (exercise performance) and sleep behavior as well as stress perception.<br>- Correlation between activity and sleep behavior as well as stress perception