NCT05638048

Brief Summary

In this study, color Doppler ultrasound diagnostic instrument and electronic grip device were used to determine the best grip strength of patients with tumor PICC catheterization, formulate precise and standardized grip strength training guidance for them, provide personalized functional exercise health education, and observe the impact of precise grip strength training guidance on Peripheral central venous catheter-associated thrombosis. To provide a reference for clinical prevention of Peripheral central venous catheter-associated thrombosis in the future.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
270

participants targeted

Target at P75+ for not_applicable lung-cancer

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

July 10, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 6, 2022

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2023

Completed
Last Updated

February 3, 2023

Status Verified

February 1, 2023

Enrollment Period

6 months

First QC Date

August 24, 2022

Last Update Submit

February 2, 2023

Conditions

Keywords

PICC;Cancer patients;Grip strength training

Outcome Measures

Primary Outcomes (1)

  • Incidence of Peripheral central venous catheter-associated thrombosis in patients with PICC tube

    Before catheterization, 24 hours after catheterization, and weekly maintenance, color Doppler ultrasound diagnostic instrument was used to diagnose venous thrombosis (including asymptomatic thrombosis) and its classification. The patients were observed for 8 weeks.

    8 weeks

Secondary Outcomes (3)

  • Hemodynamic changes of the patient

    8 weeks

  • Analysis of the influencing factors of Peripheral central venous catheter-associated thrombosis formation

    8 weeks

  • Patients' satisfaction with health education after PICC catheterization

    8 weeks

Study Arms (3)

The control group

ACTIVE COMPARATOR

Patients were routinely implanted with PICC and received routine health education. The content of health education included face-to-face language explanation of the whole process of catheter knowledge, issuing catheter maintenance manual, issuing ordinary grip ball and telling how to use it, and follow-up.

Behavioral: Health education on routine grip strength training

Experiment 1 set

EXPERIMENTAL

Patients were routinely implanted with PICC, and the optimal duration-relaxation time of grip strength training was adopted on the basis of health education in the control group.

Behavioral: Use maximum strength grip training

Experiment 2 set

EXPERIMENTAL

On the basis of control group 1. Determine the best grip strength On the basis of the control group, color Doppler ultrasound and electronic grip force were used to record the optimal grip strength of patients to achieve effective blood flow velocity before and 24 hours after PICC insertion. 2. Design precise grip strength training guidance program On the basis of the control group, the patients were instructed to perform grip strength training according to the determined best grip strength and the best duration of clenching and relaxation time.

Behavioral: Precision grip training

Interventions

First determine patients for holding the ball movement should reach the effective blood flow velocity and best duration - relaxation, and USES the electronic grips and color doppler ultrasonic diagnostic apparatus, for individual patients to choose the best grip the efforts and training, to form the best grip the training plan, and observe the scheme for Peripheral central venous catheter-associated thrombosis prevention effect.

Experiment 2 set

Patients were routinely implanted with PICC, and on the basis of health education in the control group, the best continuous-relaxation time, frequency and maximum grip strength of patients were used for grip strength training.

Experiment 1 set

Patients were routinely implanted with PICC and received routine health education. The content of health education included face-to-face language explanation of the whole process of catheter knowledge, issuing catheter maintenance manual, issuing ordinary grip ball and telling how to use it, and follow-up.

The control group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Cancer patients undergoing chemotherapy throughout their treatment in our hospital
  • Patients with PICC implanted for the first time and maintained at our hospital;
  • Age 18-60 years;
  • Normal cognitive function;
  • the clenching movement is barrier-free;
  • The material and performance of PICC catheter are silicone three-way valve catheter;
  • Catheter placement under the guidance of portable color Doppler ultrasound diagnostic instrument;
  • Voluntarily participate and sign the informed consent form.

You may not qualify if:

  • Patients treated with combined radiotherapy;
  • Patients with coagulation dysfunction;
  • Patients who need to use anticoagulant drugs due to underlying diseases;
  • Puncture times more than 1 time;
  • The blood flow velocity of catheterization vessel in calm state was less than 4.78cm/s.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qianfoshan Hospital

Jinan, Shandong, 250000, China

Location

MeSH Terms

Conditions

Lung NeoplasmsStomach NeoplasmsBreast NeoplasmsLiver NeoplasmsColonic NeoplasmsRectal Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesLiver DiseasesColorectal NeoplasmsIntestinal NeoplasmsColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Junyan Zhao, Master

    Qianfoshan Hospital

    STUDY DIRECTOR
  • Yuanjing Qiao, Master

    Shandong University of Traditional Chinese Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 24, 2022

First Posted

December 6, 2022

Study Start

July 10, 2022

Primary Completion

December 31, 2022

Study Completion

January 10, 2023

Last Updated

February 3, 2023

Record last verified: 2023-02

Locations