Congenital Heart DiseaseNCT03488797
Web-based Motor Intervention to Increase Health Related Physical Fitness in Children With Congenital Heart Disease
A study testing Supervised web- and home-based exercise intervention in people with Congenital Heart Disease and Health Related Physical Fitness, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Congenital Heart Disease, Health Related Physical Fitness, Motor Skills
- What is being tested?
- Supervised web- and home-based exercise intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2018to 17 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Paediatric Cardiology and Congenital Heart Defects, German Heart Center of the State Bavaria (Munich), Technical University of Munich (TUM)
München
About this study
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.
- Conditions
- Congenital Heart Disease, Health Related Physical Fitness, Motor Skills, Cardiovascular Prevention
- Being tested
- Supervised web- and home-based exercise intervention
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised web- and home-based exercise interventionBehavioural
- 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)
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Supervised web- and home-based exercise intervention Receives: Behavioral: Supervised web- and home-based exercise intervention |
| No Intervention | No intervention | Control group - Standard of Care * Re-assessment 24 weeks (6 month) after enrolment. * Afterwards crossover into experimental group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 24 weeks
Secondary outcomes (5)
Compliance with the supervised web- and home-based intervention
Participation rate in training sessions (%)
Measured: at 24 weeks
Central/peripheral blood pressure
mean change in mmHg between intervention and control group
Measured: at 24 weeks
Intima media thickness
mean change in mm between intervention and control group
Measured: at 24 weeks
Pulse-wave-velocity
mean change in m/s between intervention and control group
Measured: at 24 weeks
Change in Health-related Quality of Life (KINDL questionnaire)
Measured: at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start1 Jun 2018
- Primary completion20 Sep 2019
- Study completion17 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Collaborators
- Technical University of Munich, Robert-Enke-Stiftung, Fördergemeinschaft Deutsche Kinderherzzentren e.V
- Responsible party
- Sponsor
- Investigators
- Alfred Hager, MD, Principal investigator, Department of Paediatric Cardiology and Congenital Heart Defects, German heart center of the state of Bavaria (Munich), Technical University of Munich (TUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03488797
- Sponsor's protocol ID
- GE TUM FSH DHM I 0118
- Status last verified
- Feb 2021
- First submitted
- 12 Mar 2018
- Last updated
- 5 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33516681Meyer 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.
PubMed 30211141
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-based Motor Intervention to Increase Health Related Physical Fitness in Children With Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT03488797
- Acronym / sponsor ID
- GE TUM FSH DHM I 0118
- Conditions
- Congenital Heart Disease, Health Related Physical Fitness, Motor Skills, Cardiovascular Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Collaborators
- Technical University of Munich, Robert-Enke-Stiftung, Fördergemeinschaft Deutsche Kinderherzzentren e.V
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 20 Sep 2019 (actual)
- Study completion
- 17 Nov 2020 (actual)
- First posted
- 5 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Supervised web- and home-based exercise interventionSupervised web- and home-based exercise intervention |
| No Intervention | No intervention | –Control group - Standard of Care * Re-assessment 24 weeks (6 month) after enrolment. * Afterwards crossover into experimental group |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Behavioural | Experimental |
Primary outcome
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.
5 secondary outcomes
Compliance with the supervised web- and home-based intervention
Time frame: at 24 weeks
Central/peripheral blood pressure
Time frame: at 24 weeks
Intima media thickness
Time frame: at 24 weeks
Pulse-wave-velocity
Time frame: at 24 weeks
Change in Health-related Quality of Life (KINDL questionnaire)
Time frame: at 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
- Derived from this study: PubMed 33516681Meyer 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.
- Derived from this study: PubMed 30211141Meyer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alfred Hager, MD principal investigator
Department of Paediatric Cardiology and Congenital Heart Defects, German heart center of the state of Bavaria (Munich), Technical University of Munich (TUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised web- and home-based exercise intervention in people with Congenital Heart Disease and Health Related Physical Fitness, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of health related physical fitness (time frame: at 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03488797, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2021.