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Completed

NCT Number: NCT06240832

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

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

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Key information

Conditions

Chronic Liver Failure Digestive System Diseases End Stage Liver Disease Hepatic Insufficiency Liver Diseases Liver Failure

Age range

7 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo university

Cairo, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physical therapy exercise

Other

Endurance, strength and stretching training in Chronic liver disease children

Other names: Designated physical therapy program

Primary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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

  5. 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

  1. hemoglobin

    Time frame: 8week

    A blood sample was taken for complete blood count (CBC )hemoglobin

  2. liver enzymes

    Time frame: 8week

    A blood sample was taken for liver enzymes (Total bilirubin ,Direct bilirubin ) unit of measure (mg/dl)

  3. minerals

    Time frame: 8week

    A blood sample was taken for minerals concentration (sodium Na,potassium K, magnissium M, calciumCa, posphorus P and create) unit of measure (mmol/l)

  4. mid upper arm circumference in centimeter

    Time frame: 8 weeks

    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

  5. triceps skin fold thickness

    Time frame: 8 weeks

    it was assessed by holtain skinfold calipers in millimeter

  6. height in meter (m)

    Time frame: 8 weeks

    assessed by stadiometre

  7. weight in kilogrms (Kg)

    Time frame: 8 weeks

    assess by electronic scale

  8. body mass index

    Time frame: 8weeks

    height/weight kg/m2

  9. mid upper muscle circumference

    Time frame: 8weeks

    assessed by calculators that substract triceps skin fold thickness from mid upper arm circumference

  10. mid upper leg circumference in centimetre

    Time frame: 8 weeks

    assessed by tape measure at mid -point between iliac crest and mid of patella

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 5, 2024
Registry last updated
Feb 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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