Web-based Motor Intervention to Increase Health Related Physical Fitness in Children With Congenital Heart Disease
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2018
CompletedFirst Posted
Study publicly available on registry
April 5, 2018
CompletedStudy Start
First participant enrolled
June 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 17, 2020
CompletedFebruary 5, 2021
February 1, 2021
1.3 years
March 12, 2018
February 4, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Improvement of health related physical fitness
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.
at 24 weeks
Secondary Outcomes (5)
Compliance with the supervised web- and home-based intervention
at 24 weeks
Central/peripheral blood pressure
at 24 weeks
Intima media thickness
at 24 weeks
Pulse-wave-velocity
at 24 weeks
Change in Health-related Quality of Life (KINDL questionnaire)
at 24 weeks
Study Arms (2)
Experimental
EXPERIMENTALSupervised web- and home-based exercise intervention
No Intervention
NO INTERVENTIONControl group - Standard of Care * Re-assessment 24 weeks (6 month) after enrolment. * Afterwards crossover into experimental group
Interventions
* 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)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Deutsches Herzzentrum Muenchenlead
- Technical University of Munichcollaborator
- Robert-Enke-Stiftungcollaborator
- Fördergemeinschaft Deutsche Kinderherzzentren e.Vcollaborator
Study Sites (1)
Department of Paediatric Cardiology and Congenital Heart Defects, German Heart Center of the State Bavaria (Munich), Technical University of Munich (TUM)
München, Germany
Related Publications (2)
Meyer M, Brudy L, Fuertes-Moure A, Hager A, Oberhoffer-Fritz R, Ewert P, Muller J. E-Health Exercise Intervention for Pediatric Patients with Congenital Heart Disease: A Randomized Controlled Trial. J Pediatr. 2021 Jun;233:163-168. doi: 10.1016/j.jpeds.2021.01.058. Epub 2021 Jan 29.
PMID: 33516681DERIVEDMeyer M, Hreinsdottir A, Hacker AL, Brudy L, Oberhoffer R, Ewert P, Muller J. Web-Based Motor Intervention to Increase Health-Related Physical Fitness in Children With Congenital Heart Disease: A Study Protocol. Front Pediatr. 2018 Aug 27;6:224. doi: 10.3389/fped.2018.00224. eCollection 2018.
PMID: 30211141DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alfred Hager, MD
Department of Paediatric Cardiology and Congenital Heart Defects, German heart center of the state of Bavaria (Munich), Technical University of Munich (TUM)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2018
First Posted
April 5, 2018
Study Start
June 1, 2018
Primary Completion
September 20, 2019
Study Completion
November 17, 2020
Last Updated
February 5, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share