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

Study Overview
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Brief Summary
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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.

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

Conditions
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Congenital Heart Disease, Health Related Physical Fitness, Motor Skills, Cardiovascular Prevention

Intervention / Treatment
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* Behavioral: Supervised web- and home-based exercise intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Supervised web- and home-based exercise intervention | Behavioral: Supervised web- and home-based exercise intervention<br>* The intervention group gets access to a training platform. Every week, 3 training videos of 20 minutes each will be released on that platform with the aim to perform those during the ongoing week. Each exercise session is arranged in a video session with child friendly instructions and executions for the different exercises. The videos serve as a virtual training partner and exercise will be performed simultaneously while watching the video The overall training volume is 72 session calculated from 3 sessions per week over a duration of 24 weeks (6 month)<br>|
| No Intervention: No Intervention<br>Control group - Standard of Care Re-assessment 24 weeks (6 month) after enrolment. Afterwards crossover into experimental group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of health related physical fitness | 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. | at 24 weeks | 

Secondary Outcome Measures

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