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

G

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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