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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2019

Interventions

  • Behavioral: Supervised 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)

Arms, Groups and Cohorts

  • Experimental: Experimental
    • Supervised web- and home-based exercise intervention
  • No Intervention: No Intervention
    • Control group – Standard of Care Re-assessment 24 weeks (6 month) after enrolment. Afterwards crossover into experimental group

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 10 Years

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Deutsches Herzzentrum Muenchen
  • Collaborator
    • Institute of Preventive Pediatrics, Technical University of Munich
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Alfred Hager, MD, Principal Investigator, Department of Paediatric Cardiology and Congenital Heart Defects, German heart center of the state of Bavaria (Munich), Technical University of Munich (TUM)
  • Overall Contact(s)
    • Jan Müller, PhD, +49 89 289, j.mueller@tum.de

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