Isometric Hand-Grip Exercise for Preventing Thrombosis and Occlusion of Midline Venous Catheters: A Randomized Controlled Trial

June 11, 2026 updated by: Cesaro Elisabetta, University Hospital Padova

Effectiveness of Isometric Hand-grip Exercise in Preventing Thrombosis and Occlusion of Midline Peripheral Venous Catheters: a Randomized Controlled Trial.

evaluate whether hand-grip ball exercises reduce thrombosis and occlusions of Midline catheters in hospitalized patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The proposed intervention consists of low-intensity, short-duration, non-invasive, and non-pharmacological exercises, with an expected minimal risk profile. The aim of the study is therefore to systematically evaluate the effectiveness and safety of this practice in patients with Midline catheters, in a context of genuine scientific uncertainty, in order to generate evidence useful for clinical practice.

Primary objective To compare the effectiveness of a structured upper-limb exercise program versus usual care in reducing the incidence of Midline catheter-related thrombosis/occlusions in a population of hospitalized patients.

Associated endpoints

Incidence of Midline thrombosis (%) confirmed by ultrasound.

Study Type

Interventional

Enrollment (Estimated)

840

Phase

  • Not Applicable

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Midline catheter insertion for planned intravenous therapy lasting ≥ 7 days. Age between 18 and 70 years. Catheter inserted in the upper limb (forearm). Ability to understand and perform hand exercises with the limb bearing the venous catheter.

Written informed consent.

Exclusion Criteria:

  • Pre-existing superficial or deep venous thrombosis of the limb used for the Midline catheter.

Limb injuries or amputations. Motor or neurological impairment of the hand. Life expectancy < 7 days. Cognitive impairment/delirium. Medical contraindications to active upper-limb movement.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: standard
usual care
Experimental: handgrip
use of handgrip exercises in patients with midline catether
Other: handgrip
handgrip in patients with midline catethers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare the effectiveness of a structured upper-limb exercise program versus usual care in reducing the incidence of Midline catheter-related thrombosis/occlusions in a population of hospitalized patients.
Time Frame: from enrollment until catether removal
Incidence of Midline thrombosis (%) confirmed by ultrasound.
from enrollment until catether removal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Padova

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 (Estimated)

July 6, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

June 11, 2026

First Submitted That Met QC Criteria

June 11, 2026

First Posted (Actual)

June 17, 2026

Study Record Updates

Last Update Posted (Actual)

June 17, 2026

Last Update Submitted That Met QC Criteria

June 11, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CET 6514/AO/26

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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