Skip to main content
Clinical Trials/NCT06240832
NCT06240832
Completed
Not Applicable

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

Cairo University1 site in 1 country18 target enrollmentJune 22, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Liver Failure
Sponsor
Cairo University
Enrollment
18
Locations
1
Primary Endpoint
quadriceps strength
Status
Completed
Last Updated
2 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
June 22, 2022
End Date
June 22, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Heba Ibrahim

assistant lecturer, pediatric department of physical therapy,principle investigator

Cairo University

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.

Outcomes

Primary Outcomes

quadriceps strength

Time Frame: 8 week

it 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.

aerobic capacity

Time Frame: 8week

it 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 strength

Time Frame: 8week

it 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

health related quality of life

Time Frame: 8week

The 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

fatigue

Time Frame: 8 weeks

It 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 Outcomes

  • hemoglobin(8week)
  • liver enzymes(8week)
  • triceps skin fold thickness(8 weeks)
  • weight in kilogrms (Kg)(8 weeks)
  • minerals(8week)
  • mid upper leg circumference in centimetre(8 weeks)
  • mid upper arm circumference in centimeter(8 weeks)
  • height in meter (m)(8 weeks)
  • body mass index(8weeks)
  • mid upper muscle circumference(8weeks)

Study Sites (1)

Loading locations...

Similar Trials