- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07605832
Children With Surgically Corrected Acyanotic Congenital Heart Disease (Pediatrics)
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
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Gamasa, Egypten, 35712
- Amira Hussin Mohammed
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: congenital heart disease
The children in this group received walking sessions weekly for 10 weeks.
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4 sessions of walking on treadmill for 2.5 months
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Ingen indgriben: healthy group
health control group
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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gait parameters
Tidsramme: basiline pre-test assessment and after 10 weeks of interventions (post-intervention assessment)
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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.
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basiline pre-test assessment and after 10 weeks of interventions (post-intervention assessment)
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- Acyanotic Heart Disease
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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