Effect of Precise Grip Strength Training on PICC Catheter-Related Thrombosis in Cancer Patients

Sponsor
Junyan Zhao (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05638048
Collaborator
(none)
270
1
3
6
44.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Precision grip training
  • Behavioral: Use maximum strength grip training
  • Behavioral: Health education on routine grip strength training
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
270 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Effect of Precise Grip Strength Training on PICC Catheter-Related Thrombosis in Cancer Patients
Actual Study Start Date :
Jul 10, 2022
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Jan 10, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: The control group

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
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.

Experimental: Experiment 1 set

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
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.

Experimental: Experiment 2 set

On the basis of control group 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. 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
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.

Outcome Measures

Primary Outcome Measures

  1. Incidence of Peripheral central venous catheter-associated thrombosis in patients with PICC tube [8 weeks]

    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.

Secondary Outcome Measures

  1. Hemodynamic changes of the patient [8 weeks]

    During weekly maintenance, color Doppler ultrasound was used to measure the blood velocity of the arm axillary vein on the side of the catheter, and the maximum blood velocity (Vmax, cm/s) was recorded.

  2. Analysis of the influencing factors of Peripheral central venous catheter-associated thrombosis formation [8 weeks]

    By investigating the baseline data of patients, the related factors affecting the formation of PICC-CRT in patients with tumor tube in the baseline data of the same group were analyzed and compared.

  3. Patients' satisfaction with health education after PICC catheterization [8 weeks]

    At the end of the intervention, the patients' attitude towards PICC catheterization health education questionnaire (self-made) was distributed to the study subjects, and the satisfaction of the study subjects with the health education after PICC catheterization was learned through the questionnaire.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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.

Exclusion Criteria:
  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Qianfoshan Hospital Jinan Shandong China 250000

Sponsors and Collaborators

  • Junyan Zhao

Investigators

  • Study Director: Junyan Zhao, Master, Qianfoshan Hospital
  • Principal Investigator: Yuanjing Qiao, Master, Shandong University of Traditional Chinese Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Junyan Zhao, Principal investigator, Qianfoshan Hospital
ClinicalTrials.gov Identifier:
NCT05638048
Other Study ID Numbers:
  • YXLL-KY-2022(057)
First Posted:
Dec 6, 2022
Last Update Posted:
Dec 6, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Junyan Zhao, Principal investigator, Qianfoshan Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 6, 2022