Lung CancerNCT05638048

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

A study testing Precision grip training, Use maximum strength grip training and Health education on routine grip strength training in people with Lung Cancer and Stomach Cancer, run by Junyan Zhao at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Lung Cancer, Stomach Cancer, Breast Cancer
What is being tested?: Precision grip training, Use maximum strength grip training and Health education on routine grip strength training
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 270 participants
Where: 1 siteChina
Study dates: 10 Jul 2022to 10 Jan 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Qianfoshan Hospital
Jinan, Shandong, 250000

Other trials in China

About this study

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.

Conditions: Lung Cancer, Stomach Cancer, Breast Cancer, Liver Cancer, Colon Cancer, Rectal Cancer
Being tested: Precision grip training, Use maximum strength grip training, Health education on routine grip strength training
Keywords: PICC；Cancer patients；Grip strength training
Medical subject headings: Lung Neoplasms, Stomach Neoplasms, Breast Neoplasms, Liver Neoplasms, Colonic Neoplasms, Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Precision grip trainingBehavioural
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.
Use maximum strength grip trainingBehavioural
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.
Health education on routine grip strength trainingBehavioural
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.

Study groups in NCT05638048
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Behavioral: Precision grip training

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 8 weeks

Secondary outcomes (3)

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.
Measured: 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.
Measured: 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.
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jul 202210 Jan 2023

First posted6 Dec 2022
Study start10 Jul 2022
Primary completion31 Dec 2022
Study completion10 Jan 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Lung CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 270 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05638048
Sponsor's protocol ID: YXLL-KY-2022(057)
Status last verified: Feb 2023
First submitted: 24 Aug 2022
Last updated: 3 Feb 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Precise Grip Strength Training on PICC Catheter-Related Thrombosis in Cancer Patients
ClinicalTrials.gov ID: NCT05638048
Acronym / sponsor ID: YXLL-KY-2022(057)
Conditions: Lung Cancer, Stomach Cancer, Breast Cancer, Liver Cancer, Colon Cancer, Rectal Cancer
Keywords: PICC；Cancer patients；Grip strength training
Study type: Interventional
Recruitment status: Completed
Enrolment: 270 participants (actual)
Lead sponsor: Junyan ZhaoUniversity, hospital or other
Study start: 10 Jul 2022 (actual)
Primary completion: 31 Dec 2022 (actual)
Study completion: 10 Jan 2023 (actual)
First posted: 6 Dec 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
The control group	Active comparator	Behavioral: Health education on routine grip strength trainingPatients 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.
Experiment 1 set	Experimental	Behavioral: Use maximum strength grip trainingPatients 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.
Experiment 2 set	Experimental	Behavioral: Precision grip trainingOn 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.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (8 listed)

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;

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Precision grip trainingFirst 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.	Behavioural	Experiment 2 set
Use maximum strength grip trainingPatients 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.	Behavioural	Experiment 1 set
Health education on routine grip strength trainingPatients 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.	Behavioural	The control group

Primary outcome

Incidence of Peripheral central venous catheter-associated thrombosis in patients with PICC tube
Time frame: 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.

3 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
Individual participant dataSharing planned: Undecided

Related trials for Lung Cancer

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Junyan Zhao, Master study director

Qianfoshan Hospital

Yuanjing Qiao, Master principal investigator

Shandong University of Traditional Chinese Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Peripheral central venous catheter-associated thrombosis in patients with PICC tube (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05638048.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2023.