Clinical trial NCT03488797: Web-based Motor Intervention to Increase Health Related Physical Fitness in Children With Congenital Heart Disease
Official title: Web-based Motor Intervention to Increase Health Related Physical Fitness in Children With Congenital Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Disease
Health Related Physical Fitness
Motor Skills
Cardiovascular Prevention
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
Collaborators: name: Technical University of Munich
name: Robert-Enke-Stiftung
name: Fördergemeinschaft Deutsche Kinderherzzentren e.V
First posted: 2018-04-05
Enrollment: 70
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Children with congenital heart diseases (CHD) often show reduced health related physical fitness as well as limitations in gross and fine motor skills/development. Intervention programs in childhood are still rare and often focus just on the improvement of cardiac outcomes or exercise capacity. Web-based interventions, as a useful alternative to training manuals or supervised training, are cost effective and allow a customization of training times. Primary purpose of this study is to improve health related physical fitness in children with congenital heart disease.


Eligibility criteria: Inclusion Criteria:

* Ages 10-18 years old.
* CHD with moderate to complex severity according to the ACC criteria.
* Health-related physical fitness \<50th percentile (healthy reference).
* German speaking.
* internet availability and an internet-capable device to use the intervention app
* Informed consent of parent/guardian as well as of the child.

Exclusion Criteria:

* Severe Arrhythmias
* Severe Left Heart Failure
* Chromosomal anomalies and/or genetic syndromes.
* Severe physical and/or sensory impairments (hearing, visual, or psychomotor).
* Elective cardiac intervention within the next 6 months following enrollment.

Primary outcomes:
measure: Improvement of health related physical fitness
timeFrame: at 24 weeks
Secondary outcomes:
measure: Compliance with the supervised web- and home-based intervention
timeFrame: at 24 weeks
measure: Central/peripheral blood pressure
timeFrame: at 24 weeks
measure: Intima media thickness
timeFrame: at 24 weeks
measure: Pulse-wave-velocity
timeFrame: at 24 weeks
measure: Change in Health-related Quality of Life (KINDL questionnaire)
timeFrame: at 24 weeks
Other outcomes:
Locations:
city: München
country: Germany
facility: Department of Paediatric Cardiology and Congenital Heart Defects, German Heart Center of the State Bavaria (Munich), Technical University of Munich (TUM)
Study officials:
affiliation: Department of Paediatric Cardiology and Congenital Heart Defects, German heart center of the state of Bavaria (Munich), Technical University of Munich (TUM)
name: Alfred Hager, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meyer M, Brudy L, Fuertes-Moure A, Hager A, Oberhoffer-Fritz R, Ewert P, Muller J. E-Health Exercise Intervention for Pediatric Patients with Congenital Heart Disease: A Randomized Controlled Trial. J Pediatr. 2021 Jun;233:163-168. doi: 10.1016/j.jpeds.2021.01.058. Epub 2021 Jan 29.
citation: Meyer M, Hreinsdottir A, Hacker AL, Brudy L, Oberhoffer R, Ewert P, Muller J. Web-Based Motor Intervention to Increase Health-Related Physical Fitness in Children With Congenital Heart Disease: A Study Protocol. Front Pediatr. 2018 Aug 27;6:224. doi: 10.3389/fped.2018.00224. eCollection 2018.