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Recruiting NCT06718842

Walking Program in Fatty Liver Children With Phenylketonuria

No phase Interventional Phenylketonurias Non Alcoholic Fatty Liver

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: walking free online supervised program.
Who it may be relevant to
Registry conditions: Phenylketonurias, Non Alcoholic Fatty Liver. Basic parameters: 9 years — 12 years · 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 →
Official title

Walking Program in Fatty Liver Children With Phenylketonuria: Response of Liver Enzymes

Overview

phenylketonuria (commonly known as PKU) is an inherited disorder that increases the levels of a substance called phenylalanine in the blood. PKU is usually associated with many metabolic complication including non-alcoholic fatty liver

Detailed description

this study will include PKU children sufferers 9n=40) with non-alcoholic fatty liver to be randomly assigned to group I (n=20) that will perform walking program (online supervised free walking that will be applied daily for eight weeks) or group II (N=20) that will act as waitlisted children

Interventions

  • Behavioral walking free online supervised program
    this Group I will include PKU children sufferers (n=20) with non-alcoholic fatty liver that will perform walking program (online supervised free walking that will be applied daily for eight weeks)

Primary outcome measures

  • alanine transamianse [Time frame: it will be assessed after eight weeks]
Secondary outcome measures (5)
  • aspartate tranaminase [Time frame: it will be assessed after eight weeks]
  • Gamma-glutamyl Transferase [Time frame: it will be assessed after eight weeks]
  • alkaline phosphatase [Time frame: it will be assessed after eight weeks]
  • triglycerides [Time frame: it will be assessed after eight weeks]
  • body mass index [Time frame: it will be assessed after eight weeks]

Eligibility criteria

Inclusion criteria

  • PKU children
  • obese children
  • fatty liver children (non-alcoholic fatty liver)

Exclusion criteria

  • cardiac children
  • diabetic children
  • neurogenic disorders
  • respiratory and renal problems

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

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Cairo University — Dokki

Publications

  • Ali Ismail AM, Gohary MM, Mabrouk Bondok SM, Abo Elatta AB, Ahmed El Gressy NSS, El Melhat AM, El-Sayed Felaya EE. Effect of walking exercise on liver enzymes in children with phenylketonuria and non-alcoholic fatty liver disease: A randomized controlled trial. Med Clin (Barc). 2026 Apr;166(4):107395. doi: 10.1016/j.medcli.2026.107395. Epub 2026 Mar 6. English, Spanish. PMID 41793924

Identifiers

NCT: NCT06718842 · P.T.REC/012/005449

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗