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

Chronic Liver Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06240832
• Other study ID #: P. T. REC/012/003479
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Chronic Liver Failure
• End Stage Liver Disease
• Liver Diseases
• Liver Failure

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