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Not yet recruiting NCT07605832

Children With Surgically Corrected Acyanotic Congenital Heart Disease

No phase Interventional Acyanotic Congenital Heart Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: treadmill walking sessions.
Who it may be relevant to
Registry conditions: Acyanotic Congenital Heart Disease. Basic parameters: 48 months — 72 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other treadmill walking sessions
    4 sessions of walking on treadmill for 2.5 months

Primary outcome measures

  • gait parameters [Time frame: basiline pre-test assessment and after 10 weeks of interventions (post-intervention assessment)]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

Children were excluded if they had:

  • Genetic disorders.
  • Severe neurological disorders.
  • Cyanotic congenital heart disease.
  • Perinatal complications.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Amira Hussin Mohammed — Gamasa

Identifiers

NCT: NCT07605832 · Acyanotic Heart Disease

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗