Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03488797
Recruitment Status : Not yet recruiting
First Posted : April 5, 2018
Last Update Posted : April 5, 2018
Sponsor:
Collaborators:
Institute of Preventive Pediatrics, Technical University of Munich
Robert-Enke-Stiftung
Fördergemeinschaft Deutsche Kinderherzzentren e.V
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen

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.

Condition or disease Intervention/treatment Phase
Congenital Heart Disease Health Related Physical Fitness Motor Skills Cardiovascular Prevention Behavioral: Supervised web- and home-based exercise intervention Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Web-based Motor Intervention to Increase Health Related Physical Fitness in Children With Congenital Heart Disease
Estimated Study Start Date : May 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Compliance with the supervised web- and home-based intervention [ Time Frame: at 24 weeks ]
    Participation rate in training sessions (%)

  2. Central/peripheral blood pressure [ Time Frame: at 24 weeks ]
    mean change in mmHg between intervention and control group

  3. Intima media thickness [ Time Frame: at 24 weeks ]
    mean change in mm between intervention and control group

  4. Pulse-wave-velocity [ Time Frame: at 24 weeks ]
    mean change in m/s between intervention and control group

  5. Change in Health-related Quality of Life (KINDL questionnaire) [ Time Frame: at 24 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03488797


Contacts
Layout table for location contacts
Contact: Jan Müller, PhD +49 89 289 ext 24574 j.mueller@tum.de

Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Institute of Preventive Pediatrics, Technical University of Munich
Robert-Enke-Stiftung
Fördergemeinschaft Deutsche Kinderherzzentren e.V
Investigators
Layout table for investigator information
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier: NCT03488797     History of Changes
Other Study ID Numbers: GE TUM FSH DHM I 0118
First Posted: April 5, 2018    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities