Web-based Motor Intervention to Increase Health Related Physical Fitness in Children With Congenital Heart Disease

Not Applicable

Completed

• Conditions: Congenital Heart Disease; Health Related Physical Fitness; Motor Skills; Cardiovascular Prevention
• Interventions: Behavioral: Supervised web- and home-based exercise intervention

• Registration Number: NCT03488797
• Lead Sponsor: Deutsches Herzzentrum Muenchen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-12
• Study First Submitted QC: 2018-04-04
• Study First Posted: 2018-04-05
• Study Start: 2018-06-01
• Primary Completion: 2019-09-20
• Study Completion: 2020-11-17
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-04
• Last Update Posted: 2021-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Experimental	Supervised web- and home-based exercise intervention	Supervised web- and home-based exercise intervention

Primary Outcome Measures

Name	Time	Method
Improvement of health related physical fitness	at 24 weeks	The FitnessGram® is a fitness test from the Cooper Institute that assesses health-related physical fitness. It uses evidence-based standards to measure functional health status of the musculoskeletal system divided into the components muscular strength, muscular endurance and flexibility. The FitnessGram® includes tests for the upper body and the abdominal/trunk areas. Mean scores were calculated and compared to an actual reference sample of German children and adolescents.

Secondary Outcome Measures

Name	Time	Method
Compliance with the supervised web- and home-based intervention	at 24 weeks	Participation rate in training sessions (%)
Change in Health-related Quality of Life (KINDL questionnaire)	at 24 weeks
Central/peripheral blood pressure	at 24 weeks	mean change in mmHg between intervention and control group
Pulse-wave-velocity	at 24 weeks	mean change in m/s between intervention and control group
Intima media thickness	at 24 weeks	mean change in mm between intervention and control group

Trial Locations

Locations (1)

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