Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202607879846843 Date of Registration: 10/07/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Assessment of handgrip strength as a predictor of 6-month mortality in Egyptian patients with liver cirrhosis.
Official scientific title Assessment of Handgrip Strength as a Predictor of 6-Month Mortality in Egyptian Patients with Liver Cirrhosis.
Brief summary describing the background and objectives of the trial Cirrhosis is associated with high morbidity and mortality. Frailty, malnutrition, and skeletal muscle dysfunction may worsen clinical outcomes but are not fully captured by conventional prognostic scores. Handgrip strength is a simple, inexpensive, bedside measure of muscle strength and functional reserve. This prospective observational cohort study assesses whether baseline handgrip strength, measured using a calibrated handheld dynamometer, predicts all-cause 6-month mortality among adult patients with liver cirrhosis. The study also evaluates clinical and laboratory severity markers and liver-related complications during follow-up.
Type of trial Observational
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 05/10/2025
Actual trial start date 06/10/2025
Anticipated date of last follow up 23/07/2026
Actual Last follow-up date 23/07/2026
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 80
Recruitment status Completed
Publication URL N/A
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Single Group Non-randomised Allocation Sequence/Code was not concealed Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Handgrip strength assessment Not applicable Baseline assessment, followed by 6-month follow-up Handgrip strength was measured at baseline using a calibrated handheld dynamometer. Three measurements were obtained for each hand, and patients were followed for 6 months to assess all-cause mortality. 80
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Confirmed diagnosis of liver cirrhosis based on clinical, laboratory, radiological, and/or histological evidence. - Able and willing to provide written informed consent. - Available for 6-month mortality follow-up. - Pre-existing neuromuscular disorders affecting muscle strength. - Upper-limb injury or disability interfering with handgrip strength assessment. - History of liver transplantation. - Inability to provide informed consent. - Missing baseline handgrip strength measurement or unavailable mortality follow-up Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/10/2025 The Ethics Committee of the Faculty of Medicine Alexandria University IRB No 00012098
Ethics Committee Address
Street address City Postal code Country
17 Champollion Street, El Messalah Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome All-cause mortality within 6 months after baseline handgrip Throughout the 6-month follow-up period and finally recorded at 6 months after baseline assessment.
Secondary Outcome Occurrence of liver-related decompensation events, including ascites, variceal bleeding, and hepatic encephalopathy, during follow-up. Throughout the 6-month follow-up period after baseline handgrip strength assessment.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Gastroenterology outpatient clinics Faculty of Medicine Alexandria University 17 Champollion Street, El Messalah Alexandria 21521 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ashraf Ahmed Mohamed Aboismail 17 Champollion Street, El Messalah Alexandria 21521 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tropical Medicine Department Faculty of Medicine Alexandria University 17 Champollion Street, El Messalah Alexandria 21521 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ashraf Ahmed Mohamed Aboismail 17 Champollion Street, El Messalah Alexandria 21521 Egypt
Mohamed Ahmed Abdelaziz Hussein 17 Champollion Street, El Messalah Alexandria 21521 Egypt
Abdurrahman Mohamed Najeeb 17 Champollion Street, El Messalah Alexandria 21521 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ashraf Aboismail ashraf.ahmed@alexmed.edu.eg 00201094847854 17 Champollion Street, El Messalah
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Lecturer of Tropical Medicine Faculty of Medicine Alexandria University
Role Name Email Phone Street address
Scientific Enquiries Mohamed Abdelaziz m.aziz.git@gmail.com 00201002333413 17 Champollion Street, El Messalah
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Lecturer at Internal Medicine Department Gastroenterology Unit Faculty of Medicine Alexandria University
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual data will be available (including data dictionaries) All of the individual participant data collected during the trial, after de-identification Informed Consent Form,Study Protocol Immediately following publication. No end date. Proposals should be directed to elsayedamr@yahoo.com Open access will be permitted to get the data please send an e-mail to elsayedamr@yahoo.com (public relations) Researchers decided to send data when requested No quality of request is required
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information