Back to resultsEffect of Precise Grip Strength Training on PICC Catheter-Related Thrombosis in Cancer Patients
Primary Purpose
Lung Cancer, Stomach Cancer, Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Precision grip training
Use maximum strength grip training
Health education on routine grip strength training
Sponsored by
About this trial
This is an interventional prevention trial for Lung Cancer focused on measuring PICC；Cancer patients；Grip strength training
Eligibility Criteria
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.
Sites / Locations
- Qianfoshan Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
The control group
Experiment 1 set
Experiment 2 set
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05638048
Brief Title
Effect of Precise Grip Strength Training on PICC Catheter-Related Thrombosis in Cancer Patients
Official Title
Effect of Precise Grip Strength Training on PICC Catheter-Related Thrombosis in Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 10, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
January 10, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Junyan Zhao
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Stomach Cancer, Breast Cancer, Liver Cancer, Colon Cancer, Rectal Cancer
Keywords
PICC；Cancer patients；Grip strength training
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
270 (Actual)
8. Arms, Groups, and Interventions
Arm Title
The control group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Experiment 1 set
Arm Type
Experimental
Arm Description
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.
Arm Title
Experiment 2 set
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Precision grip training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Use maximum strength grip training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Health education on routine grip strength training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of Peripheral central venous catheter-associated thrombosis in patients with PICC tube
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Hemodynamic changes of the patient
Description
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.
Time Frame
8 weeks
Title
Analysis of the influencing factors of Peripheral central venous catheter-associated thrombosis formation
Description
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.
Time Frame
8 weeks
Title
Patients' satisfaction with health education after PICC catheterization
Description
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.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junyan Zhao, Master
Organizational Affiliation
Qianfoshan Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yuanjing Qiao, Master
Organizational Affiliation
Shandong University of Traditional Chinese Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Qianfoshan Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effect of Precise Grip Strength Training on PICC Catheter-Related Thrombosis in Cancer Patients
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