Chronic Liver FailureNCT06240832
Aerobic Capacity Muscle Strength and Health Related Quality of Life in Children With Chronic Liver Disease
A study testing Physical therapy exercise in people with Chronic Liver Failure, run by Cairo University at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 7 to 14 years
- Conditions the study is for
- Chronic Liver Failure
- What is being tested?
- Physical therapy exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Jun 2022to 22 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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
- Conditions
- Chronic Liver Failure
- Being tested
- Physical therapy exercise
- Keywords
- aerobic capacity, chronic liver disease, muscle strength
- Medical subject headings
- End Stage Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical therapy exerciseOther
Also called Designated physical therapy program
Endurance, strength and stretching training in Chronic liver disease children
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Physical therapy exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 8 weeks
Secondary outcomes (10)
hemoglobin
A blood sample was taken for complete blood count (CBC )hemoglobin
Measured: 8week
liver enzymes
A blood sample was taken for liver enzymes (Total bilirubin ,Direct bilirubin ) unit of measure (mg/dl)
Measured: 8week
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)
Measured: 8week
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
Measured: 8 weeks
triceps skin fold thickness
it was assessed by holtain skinfold calipers in millimeter
Measured: 8 weeks
height in meter (m)
assessed by stadiometre
Measured: 8 weeks
weight in kilogrms (Kg)
assess by electronic scale
Measured: 8 weeks
body mass index
height/weight kg/m2
Measured: 8weeks
mid upper muscle circumference
assessed by calculators that substract triceps skin fold thickness from mid upper arm circumference
Measured: 8weeks
mid upper leg circumference in centimetre
assessed by tape measure at mid -point between iliac crest and mid of patella
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start22 Jun 2022
- Primary completion22 May 2023
- Study completion22 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Liver FailureStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One group of children ages more than 6ys will recruited and assessed pre and post of study completion for 12week
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Ibrahim, Cairo University
- Investigators
- Heba A IBRAHIM, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06240832
- Sponsor's protocol ID
- P. T. REC/012/003479
- Status last verified
- Jan 2024
- First submitted
- 7 Jan 2024
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 24768811
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerobic Capacity Muscle Strength and Health Related Quality of Life in Children With Chronic Liver Disease
- ClinicalTrials.gov ID
- NCT06240832
- Acronym / sponsor ID
- P. T. REC/012/003479
- Conditions
- Chronic Liver Failure
- Keywords
- aerobic capacity, chronic liver disease, muscle strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 22 Jun 2022 (actual)
- Primary completion
- 22 May 2023 (actual)
- Study completion
- 22 Jun 2023 (actual)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One group of children ages more than 6ys will recruited and assessed pre and post of study completion for 12week
| Arm | Type | Receives |
|---|---|---|
| Aerobic and strength training in children with CLD | Experimental | Other: Physical therapy exerciseAEROBIC AND STRENGTHENING EXERCISE USING TREADMILL AND WEIGHT TO IMPROVE FUNCTIONAL OUTCOMES IN CHILDREN WITH CHRONIC LIVER DISEASE |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical therapy exerciseAlso: Designated physical therapy programEndurance, strength and stretching training in Chronic liver disease children | Other | Aerobic and strength training in children with CLD |
Primary outcome
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.
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
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.
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
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
10 secondary outcomes
hemoglobin
Time frame: 8week
liver enzymes
Time frame: 8week
minerals
Time frame: 8week
mid upper arm circumference in centimeter
Time frame: 8 weeks
triceps skin fold thickness
Time frame: 8 weeks
height in meter (m)
Time frame: 8 weeks
weight in kilogrms (Kg)
Time frame: 8 weeks
body mass index
Time frame: 8weeks
mid upper muscle circumference
Time frame: 8weeks
mid upper leg circumference in centimetre
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Results publication: PubMed 24768811Zenith 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heba A IBRAHIM principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical therapy exercise in people with Chronic Liver Failure, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
aerobic capacity (time frame: 8week). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06240832, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2024.