Children With Surgically Corrected Acyanotic Congenital Heart Disease (Pediatrics)

Delta University for Science and Technology

Status: Not yet enrolling

Conditions: Acyanotic Congenital Heart Disease

Treatments: Other: treadmill walking sessions

Study type: Interventional

Funder types: Other

Identifiers

NCT07605832

Acyanotic Heart Disease

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 48 to 72 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• For cyanotic postoperative congenital heart disease group:

  1. Children diagnosed with acyanotic postoperative congenital heart disease.

  2. Underwent surgical repair for CHD.

  3. Has a history of only one surgical intervention.

  4. Age between 48 and 72 months.

  5. 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:

1. Genetic disorders.
2. Severe neurological disorders.
3. Cyanotic congenital heart disease.
4. Perinatal complications.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

congenital heart disease

Experimental group

Description:

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

Treatment:

Other: treadmill walking sessions

healthy group

No Intervention group

Description:

health control group