Clinical trial NCT06240832: Aerobic Capacity Muscle Strength and Health Related Quality of Life in Children With Chronic Liver Disease
Official title: Aerobic Capacity Muscle Strength and Health Related Quality of Life in Children With Chronic Liver Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Liver Failure
Keywords: aerobic capacity
chronic liver disease
muscle strength
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 18
Sex: ALL
Minimum age (years): 7
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: One group of children ages more than 6ys will recruited and assessed pre and post of study completion for 12week
Primary purpose: TREATMENT

Brief summary: Physical therapy program for children with chronic liver disease consist of gait training, strengthening ex for UL\&ll, stretching exercise to improve physical fitness and quality of life

Detailed description: Intervention study for one group of children diagnosed with chronic liver disease ages more than 6ys, study include assessment and intervention, assessment of 6MWt, grip strength by hand held dynamometer, quadriceps strength by Lafayette, al children subjected to laboratory investigation pre and post of study completion, anthropometric measure, quality of life and fatigue assessment then all children will perform physical therapy program of gait training muscle strengthening for 8 week

Eligibility criteria: Inclusion Criteria:

* Their age ranged from7 to14 years old.
* Residence in Cairo to be able to attend the rehabilitation program.
* Diagnosis of CLD as (Wilson disease, autoimmune hepatitis, chronic cholestasis , ....etc).
* All children were medically stabled
* All children had the same socioeconomic status

Exclusion Criteria:

* Complication that prevent children from performing maximal exercise test as fracture of both upper and lower limbs, cardiovascular instability and muscle disease in patient with glycogen storage disease(GSD) or abnormal creatine phosphokinase(CPK).
* Patients with cognitive and motor disorders as in case of hepatic encephalopathy and or ascites.
* Patients who underwent liver transplantation.
* Patient with end stage liver disease.
* History of variceal bleeding from one month ago or less.
* No other system disease (chest, cardiac and nervous system).
* Medical examination no hernia.

Primary outcomes:
measure: aerobic capacity
timeFrame: 8week
measure: grip strength
timeFrame: 8week
measure: quadriceps strength
timeFrame: 8 week
measure: health related quality of life
timeFrame: 8week
measure: fatigue
timeFrame: 8 weeks
Secondary outcomes:
measure: hemoglobin
timeFrame: 8week
measure: liver enzymes
timeFrame: 8week
measure: minerals
timeFrame: 8week
measure: mid upper arm circumference in centimeter
timeFrame: 8 weeks
measure: triceps skin fold thickness
timeFrame: 8 weeks
measure: height in meter (m)
timeFrame: 8 weeks
measure: weight in kilogrms (Kg)
timeFrame: 8 weeks
measure: body mass index
timeFrame: 8weeks
measure: mid upper muscle circumference
timeFrame: 8weeks
measure: mid upper leg circumference in centimetre
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university
Study officials:
affiliation: Cairo University
name: Heba A IBRAHIM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zenith L, Meena N, Ramadi A, Yavari M, Harvey A, Carbonneau M, Ma M, Abraldes JG, Paterson I, Haykowsky MJ, Tandon P. Eight weeks of exercise training increases aerobic capacity and muscle mass and reduces fatigue in patients with cirrhosis. Clin Gastroenterol Hepatol. 2014 Nov;12(11):1920-6.e2. doi: 10.1016/j.cgh.2014.04.016. Epub 2014 Apr 24.