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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06240832
Other study ID # P. T. REC/012/003479
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 22, 2022
Est. completion date June 22, 2023

Study information

Verified date January 2024
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date June 22, 2023
Est. primary completion date May 22, 2023
Accepts healthy volunteers No
Gender All
Age group 7 Years to 14 Years
Eligibility 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.

Study Design


Intervention

Other:
Physical therapy exercise
Endurance, strength and stretching training in Chronic liver disease children

Locations

Country Name City State
Egypt Cairo university Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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 Gastroen — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary aerobic capacity 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. 8week
Primary grip strength 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 8week
Primary quadriceps strength 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. 8 week
Primary health related quality of life 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 8week
Primary fatigue 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 8 weeks
Secondary hemoglobin A blood sample was taken for complete blood count (CBC )hemoglobin 8week
Secondary liver enzymes A blood sample was taken for liver enzymes (Total bilirubin ,Direct bilirubin ) unit of measure (mg/dl) 8week
Secondary minerals A blood sample was taken for minerals concentration (sodium Na,potassium K, magnissium M, calciumCa, posphorus P and create) unit of measure (mmol/l) 8week
Secondary mid upper arm circumference in centimeter assessed 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 8 weeks
Secondary triceps skin fold thickness it was assessed by holtain skinfold calipers in millimeter 8 weeks
Secondary height in meter (m) assessed by stadiometre 8 weeks
Secondary weight in kilogrms (Kg) assess by electronic scale 8 weeks
Secondary body mass index height/weight kg/m2 8weeks
Secondary mid upper muscle circumference assessed by calculators that substract triceps skin fold thickness from mid upper arm circumference 8weeks
Secondary mid upper leg circumference in centimetre assessed by tape measure at mid -point between iliac crest and mid of patella 8 weeks
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