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Physiological health assessment in adults with congenital heart defect (ACHD) - exercise, fitness, stress, sleep and blood vessels

Recruiting
Conditions
Q23
Q22
Q21
Q25
Q26
Q20
Q24
Q27
Q28
Congenital 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
NameTimeMethod
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
NameTimeMethod
- 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
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