Acyanotic Congenital Heart DiseasePediatricsNCT07605832
Children With Surgically Corrected Acyanotic Congenital Heart Disease
A study testing treadmill walking sessions in people with Acyanotic Congenital Heart Disease, run by Delta University for Science and Technology at 1 site in Egypt.
Trial summary
The goal of this quasi-experimental pretest-posttest controlled study is to learn whether moderate-intensity treadmill exercise can improve gait kinematics, walking capacity, and motor performance in preschool children aged 48-72 months with surgically corrected acyanotic congenital heart disease. Read more about this study
- Who is it for?
- Ages 48 to 72 months
- Conditions the study is for
- Acyanotic Congenital Heart Disease
- What is being tested?
- treadmill walking sessions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 31 May 2026to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 48 to 72 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- For cyanotic postoperative congenital heart disease group:
- Children diagnosed with acyanotic postoperative congenital heart disease.
- Underwent surgical repair for CHD.
- Has a history of only one surgical intervention.
- Age between 48 and 72 months.
- Mentally normal, with an IQ between 85 and 115.
- For the healthy control group (HCG):
- For healthy children aged 48 to 72 months. Full school attendance. Full participation in social and recreational activities. Parents/guardians provided written informed consent.
Who cannot join
- Children were excluded if they had:
- Genetic disorders.
- Severe neurological disorders.
- Cyanotic congenital heart disease.
- Perinatal complications.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this quasi-experimental pretest-posttest controlled study is to learn whether moderate-intensity treadmill exercise can improve gait kinematics, walking capacity, and motor performance in preschool children aged 48-72 months with surgically corrected acyanotic congenital heart disease.
The main questions it aims to answer are:
Read more
Does moderate-intensity treadmill training improve gait kinematics, including stride length, walking speed, and double-stance percentage? Does moderate-intensity treadmill training improve walking capacity and balance in children with surgically corrected acyanotic congenital heart disease?
Researchers compared children with surgically corrected acyanotic congenital heart disease who received treadmill training with age-matched healthy children to see whether the exercise program could reduce gait, balance, and walking-capacity differences between the groups.
Participants with congenital heart disease completed:
Four treadmill walking sessions per week for 10 weeks. Moderate-intensity walking at approximately 70% of maximal heart rate. Pre- and post-intervention assessments of gait kinematics using three-dimensional motion analysis.
Balance assessment using the Pediatric Balance Scale. Walking capacity assessment using the six-minute walk test.
- Conditions
- Acyanotic Congenital Heart Disease
- Being tested
- treadmill walking sessions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treadmill walking sessionsOther
4 sessions of walking on treadmill for 2.5 months
| Study group | Role | What they receive |
|---|---|---|
| congenital heart disease | Experimental | The children in this group received walking sessions weekly for 10 weeks. Receives: Other: treadmill walking sessions |
| healthy group | No intervention | health control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
gait parameters
Gait parameters, including stride length (cm), speed (meters/minute), and double stance percentage (%) of the dominant leg, were assessed using a 3D motion analysis system.
Measured: basiline pre-test assessment and after 10 weeks of interventions (post-intervention assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start31 May 2026 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acyanotic 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Delta University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07605832
- Sponsor's protocol ID
- Acyanotic Heart Disease
- Acronym
- Pediatrics
- Status last verified
- Apr 2026
- First submitted
- 9 May 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All the required data that support the conclusion will be available when requested.
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Children With Surgically Corrected Acyanotic Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT07605832
- Acronym / sponsor ID
- Pediatrics / Acyanotic Heart Disease
- Conditions
- Acyanotic Congenital Heart Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Delta University for Science and TechnologyUniversity, hospital or other
- Study start
- 31 May 2026 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 26 May 2026 (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.
The goal of this quasi-experimental pretest-posttest controlled study is to learn whether moderate-intensity treadmill exercise can improve gait kinematics, walking capacity, and motor performance in preschool children aged 48-72 months with surgically corrected acyanotic congenital heart disease.
The main questions it aims to answer are:
Does moderate-intensity treadmill training improve gait kinematics, including stride length, walking speed, and double-stance percentage? Does moderate-intensity treadmill training improve walking capacity and balance in children with surgically corrected acyanotic congenital heart disease?
Researchers compared children with surgically corrected acyanotic congenital heart disease who received treadmill training with age-matched healthy children to see whether the exercise program could reduce gait, balance, and walking-capacity differences between the groups.
Participants with congenital heart disease completed:
Four treadmill walking sessions per week for 10 weeks. Moderate-intensity walking at approximately 70% of maximal heart rate. Pre- and post-intervention assessments of gait kinematics using three-dimensional motion analysis.
Balance assessment using the Pediatric Balance Scale. Walking capacity assessment using the six-minute walk test.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| congenital heart disease | Experimental | Other: treadmill walking sessionsThe children in this group received walking sessions weekly for 10 weeks. |
| healthy group | No intervention | –health control group |
Who may qualify
- Ages
- 48 to 72 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- For cyanotic postoperative congenital heart disease group:
- For healthy children aged 48 to 72 months. Full school attendance. Full participation in social and recreational activities. Parents/guardians provided written informed consent.
Key exclusion criteria (5 listed)
- Genetic disorders.
- Severe neurological disorders.
- Cyanotic congenital heart disease.
- Perinatal complications.
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 |
|---|---|---|
| treadmill walking sessions4 sessions of walking on treadmill for 2.5 months | Other | congenital heart disease |
Primary outcome
gait parameters
Time frame: basiline pre-test assessment and after 10 weeks of interventions (post-intervention assessment)
Gait parameters, including stride length (cm), speed (meters/minute), and double stance percentage (%) of the dominant leg, were assessed using a 3D motion analysis system.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: No. All the required data that support the conclusion will be available when requested.
Related trials for Acyanotic Congenital Heart Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing treadmill walking sessions in people with Acyanotic Congenital Heart Disease, run by Delta University for Science and Technology at 1 site in Egypt.
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 8 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: opening soon, as of the sponsor's last update on 26 May 2026. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
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?
gait parameters (time frame: basiline pre-test assessment and after 10 weeks of interventions (post-intervention assessment)). 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 26 May 2026.