Children With Surgically Corrected Acyanotic Congenital Heart Disease

NCT07605832 | Not Yet Recruiting

• 1 other identifier: Acyanotic Heart Disease
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Acyanotic Congenital Heart Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  basiline pre-test assessment and after 10 weeks of interventions (post-intervention assessment)

Study Arms (2)

congenital heart disease

EXPERIMENTAL

The children in this group received walking sessions weekly for 10 weeks.

Other: treadmill walking sessions

healthy group

NO INTERVENTION

health control group

Interventions

treadmill walking sessions OTHER

4 sessions of walking on treadmill for 2.5 months

congenital heart disease

Eligibility Criteria

• Age: 48 Months - 72 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Children were excluded if they had:
• Genetic disorders.
• Severe neurological disorders.
• Cyanotic congenital heart disease.
• Perinatal complications.

Sponsors & Collaborators

• Delta University for Science and Technology: lead

Study Sites (1)

Amira Hussin Mohammed

Gamasa, 35712, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2026
• First Posted: May 26, 2026
• Study Start: May 31, 2026
• Primary Completion: August 31, 2026
• Study Completion: September 1, 2026
• Last Updated: May 26, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)