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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2020-11-17

Brief Summary

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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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Detailed Description

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Conditions

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Congenital Heart Disease Health Related Physical Fitness Motor Skills Cardiovascular Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Experimental

Supervised web- and home-based exercise intervention

Group Type EXPERIMENTAL

Supervised web- and home-based exercise intervention

Intervention Type 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)

No Intervention

Control group - Standard of Care

* Re-assessment 24 weeks (6 month) after enrolment.
* Afterwards crossover into experimental group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alfred Hager, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Paediatric Cardiology and Congenital Heart Defects, German heart center of the state of Bavaria (Munich), Technical University of Munich (TUM)