Skip to main content
Clinical Trials/NCT03488797
NCT03488797
Completed
Not Applicable

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

Deutsches Herzzentrum Muenchen1 site in 1 country70 target enrollmentJune 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Congenital Heart Disease
Sponsor
Deutsches Herzzentrum Muenchen
Enrollment
70
Locations
1
Primary Endpoint
Improvement of health related physical fitness
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2018
End Date
November 17, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Deutsches Herzzentrum Muenchen
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Improvement of health related physical fitness

Time Frame: 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 Outcomes

  • Compliance with the supervised web- and home-based intervention(at 24 weeks)
  • Change in Health-related Quality of Life (KINDL questionnaire)(at 24 weeks)
  • Central/peripheral blood pressure(at 24 weeks)
  • Pulse-wave-velocity(at 24 weeks)
  • Intima media thickness(at 24 weeks)

Study Sites (1)

Loading locations...

Similar Trials