search
Back to results

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

Primary Purpose

Congenital Heart Disease, Health Related Physical Fitness, Motor Skills

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Supervised web- and home-based exercise intervention
Sponsored by
Deutsches Herzzentrum Muenchen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Congenital Heart Disease

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental

No Intervention

Arm Description

Supervised web- and home-based exercise intervention

Control group - Standard of Care Re-assessment 24 weeks (6 month) after enrolment. Afterwards crossover into experimental group

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
March 12, 2018
Last Updated
February 4, 2021
Sponsor
Deutsches Herzzentrum Muenchen
Collaborators
Institute of Preventive Pediatrics, Technical University of Munich, Robert-Enke-Stiftung, Fördergemeinschaft Deutsche Kinderherzzentren e.V
search

1. Study Identification

Unique Protocol Identification Number
NCT03488797
Brief Title
Web-based Motor Intervention to Increase Health Related Physical Fitness in Children With Congenital Heart Disease
Official Title
Web-based Motor Intervention to Increase Health Related Physical Fitness in Children With Congenital Heart Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
September 20, 2019 (Actual)
Study Completion Date
November 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Deutsches Herzzentrum Muenchen
Collaborators
Institute of Preventive Pediatrics, Technical University of Munich, Robert-Enke-Stiftung, Fördergemeinschaft Deutsche Kinderherzzentren e.V

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease, Health Related Physical Fitness, Motor Skills, Cardiovascular Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Supervised web- and home-based exercise intervention
Arm Title
No Intervention
Arm Type
No Intervention
Arm Description
Control group - Standard of Care Re-assessment 24 weeks (6 month) after enrolment. Afterwards crossover into experimental group
Intervention Type
Behavioral
Intervention Name(s)
Supervised web- and home-based exercise intervention
Intervention Description
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 Outcome Measure Information:
Title
Improvement of health related physical fitness
Description
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.
Time Frame
at 24 weeks
Secondary Outcome Measure Information:
Title
Compliance with the supervised web- and home-based intervention
Description
Participation rate in training sessions (%)
Time Frame
at 24 weeks
Title
Central/peripheral blood pressure
Description
mean change in mmHg between intervention and control group
Time Frame
at 24 weeks
Title
Intima media thickness
Description
mean change in mm between intervention and control group
Time Frame
at 24 weeks
Title
Pulse-wave-velocity
Description
mean change in m/s between intervention and control group
Time Frame
at 24 weeks
Title
Change in Health-related Quality of Life (KINDL questionnaire)
Time Frame
at 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alfred Hager, MD
Organizational Affiliation
Department of Paediatric Cardiology and Congenital Heart Defects, German heart center of the state of Bavaria (Munich), Technical University of Munich (TUM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Paediatric Cardiology and Congenital Heart Defects, German Heart Center of the State Bavaria (Munich), Technical University of Munich (TUM)
City
München
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33516681
Citation
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.
Results Reference
derived
PubMed Identifier
30211141
Citation
Meyer 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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs