- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06240832
Aerobic Capacity Muscle Strength and Health Related Quality of Life in Children With Chronic Liver Disease
January 27, 2024 updated by: Heba Ibrahim, Cairo University
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Cairo, Egypt
- Cairo University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Aerobic and strength training in children with CLD
AEROBIC AND STRENGTHENING EXERCISE USING TREADMILL AND WEIGHT TO IMPROVE FUNCTIONAL OUTCOMES IN CHILDREN WITH CHRONIC LIVER DISEASE
|
Endurance, strength and stretching training in Chronic liver disease children
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
8week
|
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
|
8week
|
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.
|
8 week
|
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
|
8week
|
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
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
hemoglobin
Time Frame: 8week
|
A blood sample was taken for complete blood count (CBC )hemoglobin
|
8week
|
liver enzymes
Time Frame: 8week
|
A blood sample was taken for liver enzymes (Total bilirubin ,Direct bilirubin ) unit of measure (mg/dl)
|
8week
|
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)
|
8week
|
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
|
8 weeks
|
triceps skin fold thickness
Time Frame: 8 weeks
|
it was assessed by holtain skinfold calipers in millimeter
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8 weeks
|
height in meter (m)
Time Frame: 8 weeks
|
assessed by stadiometre
|
8 weeks
|
weight in kilogrms (Kg)
Time Frame: 8 weeks
|
assess by electronic scale
|
8 weeks
|
body mass index
Time Frame: 8weeks
|
height/weight kg/m2
|
8weeks
|
mid upper muscle circumference
Time Frame: 8weeks
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assessed by calculators that substract triceps skin fold thickness from mid upper arm circumference
|
8weeks
|
mid upper leg circumference in centimetre
Time Frame: 8 weeks
|
assessed by tape measure at mid -point between iliac crest and mid of patella
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Heba A IBRAHIM, Cairo University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 22, 2022
Primary Completion (Actual)
May 22, 2023
Study Completion (Actual)
June 22, 2023
Study Registration Dates
First Submitted
January 7, 2024
First Submitted That Met QC Criteria
January 27, 2024
First Posted (Actual)
February 5, 2024
Study Record Updates
Last Update Posted (Actual)
February 5, 2024
Last Update Submitted That Met QC Criteria
January 27, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P. T. REC/012/003479
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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