NCT06370702

Brief Summary

Patients who have a peripherally-inserted central catheter (PICC) placed are at a risk of developing a deep vein thrombosis (DVT). At TriHealth, approximately 2-4 patients per month who have a PICC placed experience a subsequent DVT. One innovative way to possibly mitigate the risk of DVTs is hand grip exercises. The current study will be the first study to evaluate hand grip exercises for the prevention of DVTs in adult patients hospitalized in the United States.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,500

participants targeted

Target at P75+ for not_applicable

Timeline
21mo left

Started Oct 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress61%
Oct 2023Dec 2027

Study Start

First participant enrolled

October 6, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 17, 2024

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

3.7 years

First QC Date

December 19, 2023

Last Update Submit

February 12, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Deep vein thrombosis

    Incidence of deep vein thrombosis

    from PICC placement to PICC removal, up to 4 weeks

Study Arms (2)

Handgrip Exercise Group

EXPERIMENTAL

Participants will be instructed to firmly grip and squeeze the ball for 10 seconds, relax for 10 seconds and repeat for 10 minutes. They will be instructed to do this 3 times per day.

Other: Handgrip Exercises

Standard Care Group

NO INTERVENTION

Participants will receive standard care that includes no instruction about conducting hand grip exercises.

Interventions

Participants will firmly grip and squeeze the ball for 10 seconds, relax for 10 seconds and repeat for 10 minutes. They will be instructed to do this 3 times per day.

Handgrip Exercise Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Had a PICC placed in the past 24 hours by the Vascular Access Team
  • Patient is admitted to either Bethesda North Hospital or Good Samarian Hospital

You may not qualify if:

  • Under 18 years old
  • Does not speak English
  • Unable to consent to involvement in the research study
  • Has a bleeding disorder/diagnosis
  • Has a severe limb disfunction whereby they would be unable to perform the grip exercises

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

Location

Bethesda North Hospital

Cincinnati, Ohio, 45242, United States

Location

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Rachel Baker, PhD, RN

    TriHealth Nurse Researcher

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2023

First Posted

April 17, 2024

Study Start

October 6, 2023

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

December 30, 2027

Last Updated

February 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations