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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00032675
Enrollment
468
Registered
2023-09-20
Start date
2023-09-14
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

Q23 Q22 Q21 Q25 Q26 Q20 Q24 Q27 Q28

Interventions

Group 1: ACHD patients who are 18 years of age or older and present themselves to the Clinic for Pediatric Cardiology and Congenital Heart Defects at the German Heart Center Munich. Patients are appro

Sponsors

Lehrstuhl für Präventive Pädiatrie der Technischen Universität München
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Presence of congenital heart defect (must be mild, moderate, or complex by ACC criteria) - NYHA class I and II

Exclusion criteria

Exclusion criteria: - Cognitive impairments that prevent patients from understanding tasks - Taking medication, with chronotropic, dromotropic and/or bathmotropic effects - Cardiac decompensation - Pacemaker

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
- Difference in sleep quality and sleep phases between ACHD and control subjects. - Difference in objective as well as subjective stress perception between ACHD and control subjects. - Correlation between subjective stress perception and measured stress level. - Correlation between maximum oxygen uptake (exercise performance) and sleep behavior as well as stress perception. - Correlation between activity and sleep behavior as well as stress perception

Countries

Germany

Contacts

Public ContactJan Müller

Lehrstuhl für Präventive Pädiatrie der Technischen Universität München

j.mueller@tum.de+49.89.289.24575

Outcome results

None listed

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