Effect of Handgrip Strength on Portal Vein Hemodynamics in Patients With Liver Cirrhosis

NCT07116096 | Recruiting

• 1 other identifier: MZhao
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

1. 1.Background Handgrip strength , a core indicator of muscle function, has been confirmed to be significantly associated with the clinical prognosis of patients with liver cirrhosis. However, no studies have explored its correlation with portal venous hemodynamics.
2. 2.Objective The purpose of the study is to examine the effects of Handgrip strength on portal vein and left gastric vein pressure, blood flow velocity and direction in patients with liver cirrhosis, as well as its hemodynamic impact on gastroesophageal varices.
3. 3.Method Study Design: Interventional study. Detection Timing: Hemodynamic indices were measured simultaneously after patients achieved their maximum handgrip strength. Participants were divided into three groups based on the assessment methods. Group 1 (Portal Pressure Measurement Group): Before the placement of TIPS, the pressures of the portal vein and left gastric vein were measured, both before and after the handgrip strength test. Group 2 (Doppler Ultrasound Measurement Group): Measurements of portal flow velocity and direction were taken before and after the handgrip strength test, based on Doppler ultrasound. Group 3 (Endoscopic Ultrasound Measurement Group): Measurements of blood flow volume and direction in esophagogastric varices were conducted before and after the handgrip strength test, based on endoscopic ultrasonography. The inclusion and exclusion criteria were described.
4. 4.Elaboration of the Research Hypothesis 4.1. Core Hypothesis The handgrip strength level in patients with liver cirrhosis is correlated with portal venous system hemodynamic indices. Specifically, enhanced handgrip strength may affect portal hypertension and the hemodynamics of varicose veins by improving systemic muscle function or circulatory status.

Conditions

Liver Cirrhosis; Portal Hypertension

Outcome Measures

Primary Outcomes (9)

• portal pressure

  through study completion, an average of 3 minutes

• left gastric vein pressure

  through study completion, an average of 3 minutes

• portal flow velocity

  Before the handgrip strength test, and during the maximum handgrip strength phase, measurements were conducted at intervals of 15 seconds, 30 seconds, 45 seconds, and 60 seconds after the release of strength related to the HGS

• Portal vein blood flow direction

  Before the handgrip strength test, and during the maximum handgrip strength phase, measurements were conducted at intervals of 15 seconds, 30 seconds, 45 seconds, and 60 seconds after the release of strength related to the HGS

• Blood flow velocity in esophageal varices

  through study completion, an average of 3 minutes

• Blood flow direction of esophageal varices

  through study completion, an average of 3 minutes

• Diameter of esophageal varices

  through study completion, an average of 3 minutes

• Heart rate

  through study completion, an average of 3 minutes

• blood pressure

  through study completion, an average of 3 minutes

Secondary Outcomes (15)

• Serum albumin

  Baseline

• Prothrombin time

  Baseline

• triglyceride

  Baseline

• Total cholesterol

  Baseline

• Fasting blood glucose

  Baseline

Study Arms (3)

Portal pressure measurement group

EXPERIMENTAL

Device: Jamar Hand Dynamometer, Hand Dynamometer

Doppler Ultrasound Measurement Group

EXPERIMENTAL

Device: Jamar Hand Dynamometer, Hand Dynamometer

Endoscopic Ultrasound Measurement Group

EXPERIMENTAL

Device: Jamar Hand Dynamometer, Hand Dynamometer

Interventions

Jamar Hand Dynamometer, Hand Dynamometer DEVICE

Jamar Hand Dynamometer, from Illinois, USA. Maximum handgrip strength was measured three times, with each measurement lasting 3 seconds and a 1-minute interval between tests

Doppler Ultrasound Measurement Group; Endoscopic Ultrasound Measurement Group; Portal pressure measurement group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged ≥18 years old
• Clinically diagnosed with liver cirrhosis
• Endoscopic observation to determine the presence of esophagogastric varices
• Only eligible for the portal vein pressure measurement group if there are no signs of variceal bleeding for at least 14 days
• Participant or guardian is capable of comprehending the study protocol, willing to participate, and able to provide written informed consent

You may not qualify if:

• Severe congestive heart failure, or severe untreated valvular heart disease
• Moderate to severe pulmonary hypertension
• Uncontrolled systemic infection
• Lesions (e.g., cysts) or tumors in the liver parenchyma that preclude TIPS creation
• Overt hepatic encephalopathy
• Unrelieved biliary obstruction
• Child-Pugh score \> 13
• MELD score \> 18
• INR \> 5
• Platelet count \< 20 ×109/mm3
• No gastrointestinal bleeding (suitable for the ultrasound examination group and the endoscopic ultrasonography group)
• Participants who had undergone hand or wrist surgery within the previous 3 months or were unable to hold the dynamometer with the testing hand were excluded from the study.

Sponsors & Collaborators

• Shanxi Provincial People's Hospital: lead
• The First Affiliated Hospital of Shanxi Medical University: collaborator
• The Third People's Hospital of Taiyuan: collaborator
• The First Affiliated Hospital of Henan University of Science and Technology: collaborator

Study Sites (2)

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, 471003, China

RECRUITING

Shanxi Provincial People's Hospital

Taiyuan, Shanxi, 030012, China

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis; Hypertension, Portal

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mingyuan Zhao, M.D.

CONTACT

+86 134 8537 1098; zmy255255@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 11, 2025
• Study Start: August 17, 2025
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: January 13, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Sharing and email consultation will begin after December 31, 2026.

Locations

CN (2)