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NCT Number: NCT07605832

Children With Surgically Corrected Acyanotic Congenital Heart Disease

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.

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Key information

Conditions

Acyanotic Congenital Heart Disease

Age range

48 month–72 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amira Hussin Mohammed

Gamasa, 35712, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

treadmill walking sessions

Other

4 sessions of walking on treadmill for 2.5 months

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Delta University for Science and Technology