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

NCT06240832 | Completed DMC

• 1 other identifier: P. T. REC/012/003479
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Liver Failure

Keywords

aerobic capacity; chronic liver disease; muscle strength

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (10)

• hemoglobin

  8week

• liver enzymes

  8week

• minerals

  8week

• mid upper arm circumference in centimeter

  8 weeks

• triceps skin fold thickness

  8 weeks

Study Arms (1)

Aerobic and strength training in children with CLD

EXPERIMENTAL

AEROBIC AND STRENGTHENING EXERCISE USING TREADMILL AND WEIGHT TO IMPROVE FUNCTIONAL OUTCOMES IN CHILDREN WITH CHRONIC LIVER DISEASE

Other: Physical therapy exercise

Interventions

Physical therapy exercise OTHER

Endurance, strength and stretching training in Chronic liver disease children

Also known as: Designated physical therapy program

Aerobic and strength training in children with CLD

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university

Cairo, Egypt

Location

Related 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 Gastroenterol Hepatol. 2014 Nov;12(11):1920-6.e2. doi: 10.1016/j.cgh.2014.04.016. Epub 2014 Apr 24.

  PMID: 24768811 RESULT

MeSH Terms

Conditions

End Stage Liver Disease

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Study Officials

• Heba A IBRAHIM

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer, pediatric department of physical therapy,principle investigator

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

Study Record Dates

• First Submitted: January 7, 2024
• First Posted: February 5, 2024
• Study Start: June 22, 2022
• Primary Completion: May 22, 2023
• Study Completion: June 22, 2023
• Last Updated: February 5, 2024

Record last verified: 2024-01

Locations

EG (1)