Heart Defects, CongenitalNCT00436098
Pediatric Exercise With Congenital Heart Defects (Kinderturnen Mit Angeborenem Herzfehler)
A study testing Motorpedagogic exercise in people with Heart Defects, Congenital, run by Deutsches Herzzentrum Muenchen at 2 sites in Germany.
Trial summary
Children with congenital heart defects have shown to develop motor coordinative deficiencies. In this study we want to show that a motor pedagogic physical training can improve the coordinative capabilities of children aged 4-6 years. Read more about this study
- Who is it for?
- Ages 4 to 7 years
- Conditions the study is for
- Heart Defects, Congenital
- What is being tested?
- Motorpedagogic exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesGermany
- Study dates
- Feb 2007to May 2010
- 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 4 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- without significant residuals hemodynamically not significant
- without significant residuals after repair
- age 4-6 incl.
Who cannot join
- gradient at coarctation site > 20 mmHg
- gradient RVOT, PV, LVOT, or AoV > 30 mmHg
- right-left shunt (rest or exercise)
- left-right shunt with dilatation or failure of ana cardiac chamber
- pulmonary hypertension
- heart failure, necessitating therapy
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- (suspected) myocarditis or cardiomyopathy
- significant arrhythmia
- ion channel defects, other arrhythmic diseases
- Fontan-like circulation
- repair by atrial switch
- oral anticoagulation
- other medical problems curtailing exercise capacity
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
Deutsches Herzzentrum Muenchen
Munich, D-80636
Milka Pringsheim, MD
- Recruiting
Kuratorium für Prävention und Rehabilitation der TU München
Munich, D-80809
Christoph Lammel, PhD, +49-89-289 ext. 24420, kuratorium.pr@sport.med.tum.de
Christoph Lammel, PhD
About this study
Children with congenital heart defects have shown to develop motor coordinative deficiencies. In this study we want to show that a motor pedagogic physical training can improve the coordinative capabilities of children aged 4-6 years.
Read the detailed description
The study will be performed with a randomized crossover design. After the first assessment of coordinative capabilities children were randomized into two groups. One starts with exercised training for three months. After midterm assessment of the capabilities they will pause for another 3 months and reassessed. The second group will start without training for the first three months. After midterm assessment they will train for three months and have their final assessment.
- Conditions
- Heart Defects, Congenital
- Being tested
- Motorpedagogic exercise
- Keywords
- congenital heart disease, exercise training, motorpedagogical exercise, children, CHD: hemodynamically not significant defects, CHD: acyanotic defects after repair, CHD: cyanotic defects after repair
- 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.
Motorpedagogic exerciseBehavioural
physical training
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | physical training Receives: Behavioral: Motorpedagogic exercise |
| 2 | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity: triaxial accelerometry
Measured: 3 months
Secondary outcomes (3)
coordinative test: MOT 4-6
Measured: 3 months
coordinative test: LOS KF 18
Measured: 3 months
Quality of life: Kiddy-KINDL
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completionNov 2009 (estimated)
- Study completionMay 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Defects, CongenitalStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Collaborators
- Lehrstuhl für Präventive und Rehabilitative Sportmedizin der TU Muenchen, Kuratorium für Prävention und Rehabilitation an der TU Muenchen
- Investigators
- Alfred Hager, MD, Principal investigator, Deutsches Herzzentrum München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00436098
- Sponsor's protocol ID
- GE IDE No. H00107
- Status last verified
- Aug 2008
- First submitted
- 15 Feb 2007
- Last updated
- 27 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Exercise With Congenital Heart Defects (Kinderturnen Mit Angeborenem Herzfehler)
- ClinicalTrials.gov ID
- NCT00436098
- Acronym / sponsor ID
- GE IDE No. H00107
- Conditions
- Heart Defects, Congenital
- Keywords
- congenital heart disease, exercise training, motorpedagogical exercise, children, CHD: hemodynamically not significant defects, CHD: acyanotic defects after repair, CHD: cyanotic defects after repair
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Collaborators
- Lehrstuhl für Präventive und Rehabilitative Sportmedizin der TU Muenchen, Kuratorium für Prävention und Rehabilitation an der TU Muenchen
- Study start
- Feb 2007
- Primary completion
- Nov 2009 (estimated)
- Study completion
- May 2010 (estimated)
- First posted
- 16 Feb 2007 (estimated)
- 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 defects have shown to develop motor coordinative deficiencies. In this study we want to show that a motor pedagogic physical training can improve the coordinative capabilities of children aged 4-6 years.
Detailed description
The study will be performed with a randomized crossover design. After the first assessment of coordinative capabilities children were randomized into two groups. One starts with exercised training for three months. After midterm assessment of the capabilities they will pause for another 3 months and reassessed. The second group will start without training for the first three months. After midterm assessment they will train for three months and have their final assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Motorpedagogic exercisephysical training |
| 2 | No intervention | – |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- without significant residuals hemodynamically not significant
- without significant residuals after repair
- age 4-6 incl.
Key exclusion criteria (13 listed)
- gradient at coarctation site > 20 mmHg
- gradient RVOT, PV, LVOT, or AoV > 30 mmHg
- right-left shunt (rest or exercise)
- left-right shunt with dilatation or failure of ana cardiac chamber
- pulmonary hypertension
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 |
|---|---|---|
| Motorpedagogic exercisephysical training | Behavioural | 1 |
Primary outcome
Activity: triaxial accelerometry
Time frame: 3 months
3 secondary outcomes
coordinative test: MOT 4-6
Time frame: 3 months
coordinative test: LOS KF 18
Time frame: 3 months
Quality of life: Kiddy-KINDL
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2008.
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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
Deutsches Herzzentrum München
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motorpedagogic exercise in people with Heart Defects, Congenital, run by Deutsches Herzzentrum Muenchen at 2 sites 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 3 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 27 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alfred Hager, MD (+49-89-1218 ext. 1650, a-hager@web.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activity: triaxial accelerometry (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Aug 2008.