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临床试验/NCT06240832
NCT06240832已完成不适用

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

Cairo University1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2022年6月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
1
主要终点
quadriceps strength

研究概览

简要总结

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

详细描述

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

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
7 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

quadriceps strength

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Heba Ibrahim

assistant lecturer, pediatric department of physical therapy,principle investigator

Cairo University

研究点 (1)

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