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

Congenital Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03488797
• Other study ID #: GE TUM FSH DHM I 0118
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: November 17, 2020

Study information

• Verified date: February 2021
• Source: Deutsches Herzzentrum Muenchen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 17, 2020
• Est. primary completion date: September 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Prevention
• Congenital Heart Disease
• Health Related Physical Fitness
• Heart Defects, Congenital
• Heart Diseases
• Motor Skills

Intervention

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)

Locations

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

Sponsors (4)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen	Fördergemeinschaft Deutsche Kinderherzzentren e.V, Institute of Preventive Pediatrics, Technical University of Munich, Robert-Enke-Stiftung

Country where clinical trial is conducted

Germany, 

Outcome

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