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

February 4, 2021 updated by: Deutsches Herzzentrum Muenchen
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Experimental
Supervised web- and home-based exercise 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)
NO_INTERVENTION: No Intervention

Control group - Standard of Care

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at 24 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deutsches Herzzentrum Muenchen

Collaborators

Robert-Enke-Stiftung
Institute of Preventive Pediatrics, Technical University of Munich
Fördergemeinschaft Deutsche Kinderherzzentren e.V

Investigators

  • 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)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2018

Primary Completion (ACTUAL)

September 20, 2019

Study Completion (ACTUAL)

November 17, 2020

Study Registration Dates

First Submitted

March 12, 2018

First Submitted That Met QC Criteria

April 4, 2018

First Posted (ACTUAL)

April 5, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 5, 2021

Last Update Submitted That Met QC Criteria

February 4, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GE TUM FSH DHM I 0118

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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