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Completed

NCT Number: NCT03488797

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

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.

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Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Cardiovascular Prevention Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Health Related Physical Fitness Heart Defects, Congenital Heart Diseases Motor Skills

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Paediatric Cardiology and Congenital Heart Defects, German Heart Center of the State Bavaria (Munich), Technical University of Munich (TUM)

München, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Supervised web- and home-based exercise intervention

Behavioral
  • 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)

Primary outcomes

  1. 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

  1. Compliance with the supervised web- and home-based intervention

    Time frame: at 24 weeks

    Participation rate in training sessions (%)

  2. Central/peripheral blood pressure

    Time frame: at 24 weeks

    mean change in mmHg between intervention and control group

  3. Intima media thickness

    Time frame: at 24 weeks

    mean change in mm between intervention and control group

  4. Pulse-wave-velocity

    Time frame: at 24 weeks

    mean change in m/s between intervention and control group

  5. Change in Health-related Quality of Life (KINDL questionnaire)

    Time frame: at 24 weeks

Sponsors and collaborators

Lead sponsor

Deutsches Herzzentrum Muenchen

Other

Collaborators

  • Fördergemeinschaft Deutsche Kinderherzzentren e.V
  • Robert-Enke-Stiftung
  • Technical University of Munich

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Apr 5, 2018
Registry last updated
Feb 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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