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Clinical Trials in Germany / NCT06626672
Recruiting Not applicable

Digital Health Promotion for Children With Congenital Heart Disease and Their Guardians

NCT06626672 · tracked via the Priya Life Science Germany tracker
Phase
Not applicable
Started
2024-10-01
Last updated
2025-01-29

Condition(s) studied

Congenital Heart DiseasePediatric ALL

Investigational drug(s) / intervention(s)

Digital Health Intervention

Digital Health Intervention: Access to a digital platform including weekly workout videos, live workouts, recipes, study summaries, and a consultation hour.

Study summary

Congenital heart disease (CHD) affects approximately 1% of live births, and children with CHD often fail to meet WHO physical activity guidelines. Digital interventions to promote physical activity in CHD patients are limited. This study will develop and test a 12-week digital lifestyle intervention for children (ages 8-13) and their guardians, using a Garmin Vivofit Jr. 2 wearable to continuously monitor physical activity (PA). We will assess its impact on children's moderate to vigorous intensity physical activity (MVPA), daily activity (steps per day), quality of life, nutrition, and health literacy, as well as the quality of life and health literacy of their parents.

Eligibility

Sex
ALL
Min age
8 Years
Max age
14 Years
Healthy volunteers
No
Inclusion Criteria: * Ages 8-14 years * Presence of a congenital heart defect (must be moderate or complex according to ACC criteria) * NYHA Class I or II * Presence of written informed consent Exclusion Criteria: * Cognitive impairments that inhibit patients from understanding the tasks * No sports clearance by paediatric cardiologists

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Department of Paediatric Cardiology and Congenital Heart Defects, German Heart Center of the State Bavaria (Munich), Technical University of Munich (TUM) München Germany Recruiting

More Deutsches Herzzentrum Muenchen trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06626672 on ClinicalTrials.gov ↗ ← All trials in Germany