Cardiovascular Prevention, Congenital Heart Disease, Health Related Physical Fitness, Motor Skills
Conditions
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.
Interventions
BEHAVIORALSupervised web- and home-based exercise intervention
* 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)
Sponsors
Technical University of Munich
Robert-Enke-Stiftung
Fördergemeinschaft Deutsche Kinderherzzentren e.V
Deutsches Herzzentrum Muenchen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Compliance with the supervised web- and home-based intervention | at 24 weeks | Participation rate in training sessions (%) |
| Central/peripheral blood pressure | at 24 weeks | mean change in mmHg between intervention and control group |
| Intima media thickness | at 24 weeks | mean change in mm between intervention and control group |
| Pulse-wave-velocity | at 24 weeks | mean change in m/s between intervention and control group |
| Change in Health-related Quality of Life (KINDL questionnaire) | at 24 weeks | — |
Countries
Germany
Outcome results
None listed