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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Stomach Cancer; Breast Cancer; Lung Cancer; Rectal Cancer; Colon Cancer; Liver Cancer
• Intervention / Treatment: Behavioral: Health education on routine grip strength training; Behavioral: Use maximum strength grip training; Behavioral: Precision grip training

• Study Type: Interventional
• Enrollment (Actual): 270
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250000
      • Qianfoshan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemodynamic changes of the patient	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.	8 weeks
Analysis of the influencing factors of Peripheral central venous catheter-associated thrombosis formation	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.	8 weeks
Patients' satisfaction with health education after PICC catheterization	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.	8 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2022
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): January 10, 2023

Study Registration Dates

• First Submitted: August 24, 2022
• First Submitted That Met QC Criteria: December 1, 2022
• First Posted (Estimate): December 6, 2022

Study Record Updates

• Last Update Posted (Estimate): December 6, 2022
• Last Update Submitted That Met QC Criteria: December 1, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: PICC；Cancer patients；Grip strength training
• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Embolism and Thrombosis; Stomach Neoplasms; Thrombosis
• Other Study ID Numbers: YXLL-KY-2022(057)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No