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Aerobic Capacity Muscle Strength and Health Related Quality of Life in Children With Chronic Liver Disease

Aerobic Capacity Muscle Strength and Health Related Quality of Life in Children With Chronic Liver Disease

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06240832
Enrollment
18
Registered
2024-02-05
Start date
2022-06-22
Completion date
2023-06-22
Last updated
2024-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Liver Failure

Keywords

aerobic capacity, chronic liver disease, muscle strength

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

Interventions

Endurance, strength and stretching training in Chronic liver disease children

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

One group of children ages more than 6ys will recruited and assessed pre and post of study completion for 12week

Eligibility

Sex/Gender
ALL
Age
7 Years to 14 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
aerobic capacity8weekit was assessed by 6 minute walk test(6-MWT) in meter, The distance in meters was recorded at the end of the six minutes.
grip strength8weekit was assessed by pneumatic hand held dynamometer ,was measured in pounds per square inch (PSI). The child was sitting on a chair with or without arm rest, back supported, and both feet rested on the floor. The right arm was beside the body, with adducted shoulder, elbow flexed 90°, forearm in neutral position, wrist from 0° to 30° extension, and 0° to 15° of ulnar deviation. Child was instructed to hold and compress the pneumatic handle of dynamometer as much strength as possible with the tested hand
quadriceps strength8 weekit was assessed by Lafayette hand held dynamometer(LHHD)Child position was sitting on chair with back straight, hip and knee were in 90-degree flexion. LHHD was fixed on distal third of anterior surface of child leg while his/her tested thigh was stabilizing and then the child was instructed to perform maximal isometric knee extension and hold for 6 sec against LHHD sensor pad.
health related quality of life8weekThe Arabic version of child self-report Pediatric Quality of Life Inventory core scale version 4 (PedsQI) was used to assess HRQOL. PedsQI core scale designed to measure HRQOL in children and adolescents ages from 2 to18years. Each item of the questionnaire rated based on a rating scale from 0-4. Then, each item score was linearly converted on assessment scale from 0 to 100;0=100, 1=75, 2=50, 3=25, 4=0 then overall score calculated for all domains through dividing all answered items over whole number of items, with higher scores indicate a better HRQOL
fatigue8 weeksIt was assessed by the PedsQI multidimensional fatigue scale version 3. It is composed of 3 domains; general fatigue, sleep/rest fatigue and cognitive fatigue,Each item score converted on a scale from 0 to 100: 0=100, 1=75, 2=50, 3=25, 4=0 then overall score calculated for all domains through dividing all answered items over whole number of items, with higher scores indicate lower level of fatigue

Secondary

MeasureTime frameDescription
height in meter (m)8 weeksassessed by stadiometre
weight in kilogrms (Kg)8 weeksassess by electronic scale
hemoglobin8weekA blood sample was taken for complete blood count (CBC )hemoglobin
mid upper muscle circumference8weeksassessed by calculators that substract triceps skin fold thickness from mid upper arm circumference
mid upper leg circumference in centimetre8 weeksassessed by tape measure at mid -point between iliac crest and mid of patella
body mass index8weeksheight/weight kg/m2
liver enzymes8weekA blood sample was taken for liver enzymes (Total bilirubin ,Direct bilirubin ) unit of measure (mg/dl)
minerals8weekA blood sample was taken for minerals concentration (sodium Na,potassium K, magnissium M, calciumCa, posphorus P and create) unit of measure (mmol/l)
mid upper arm circumference in centimeter8 weeksassessed by tape measure,the tape was passed around the arm at the mid-point of the upper right arm halfway between the acromion process and the olecranon process
triceps skin fold thickness8 weeksit was assessed by holtain skinfold calipers in millimeter

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026