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

German Heart Center Munich

Status: Completed

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

Treatments: Behavioral: Supervised web- and home-based exercise intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03488797

GE TUM FSH DHM I 0118

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Experimental

Experimental group

Description:

Supervised web- and home-based exercise intervention

Treatment:

Behavioral: Supervised web- and home-based exercise intervention

No Intervention

No Intervention group

Description:

Control group - Standard of Care * Re-assessment 24 weeks (6 month) after enrolment. * Afterwards crossover into experimental group