Systematically Intermittent Arm Exercise for Improving Maturation of Hemodialysis Arteriovenous Shunt: Study Protocol for a Randomized Controlled Trial

May 30, 2022 updated by: National Taiwan University Hospital

National Taiwan University Hospital

Arm vein intermittently gripping arm movements, can promote the increased diameter of arteriovenous fistula, which enhance the maturity of fistula, the effect of lack of empirical research. Objective: this study, randomized controlled study, investigate systematic random arm vein pressure and arm movements to arteriovenous fistula in hemodialysis patients improve the maturity rate and effectiveness of the diameter. Methods: a prospective comparative study randomly assigned.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

the effect size is the diameter of arteriovenous fistula in hemodialysis patients with treatments or not is the key to smoothly. Arm vein intermittently gripping arm movements, can promote the increased diameter of arteriovenous fistula, which enhance the maturity of fistula, the effect of lack of empirical research. Objective: this study, randomized controlled study, investigate systematic random arm vein pressure and arm movements to arteriovenous fistula in hemodialysis patients improve the maturity rate and effectiveness of the diameter. Methods: a prospective comparative study randomly assigned. This study plan for each patient has received a wrist artery and vein access tracks before and after 3 months of operation, according to randomly divided into three groups, the first group of patients after accepted guidance for systematic and intermittent arm movements; the second group of patients receiving the guidance system of intermittent arm vein compression and arm movements; a third group as a control group. Discussion: the plan is expected to include 150 patients, receive instruction after the randomly with/without systemic venous pressure, with/without systemic movement. The plan design under the patient safety assessment of the effectiveness of these two activities the primary end point and secondary end points. This study offers clinicians advise patients, how to effectively improve the patients ' arteriovenous access matured speed and diameter. Keywords: Arteriovenous shunt, compression bandages, exercise therapy, renal dialysis

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
119

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • No.7, Chung Shan S. Rd
      • Taipei, No.7, Chung Shan S. Rd, Taiwan, 10002
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Inclusion for adult patients aged 20 and above. Preoperative evaluation site assessment/operation condition full wrist wrist artery and vein arteriovenous joint surgery. Objective sufficient conditions are defined as wrist artery and vein,/objective ultrasound evaluation before surgery, vein of the arm extended diameter scan before >= 2.5 mm, radial natural >= 2.0 mm diameter scan, no significant narrowing of both forearm. Excluded conditions including following, joined research Qian found patients too weak/or heart failure too serious/or consciousness not clear/or long-term bed, both inside and outside section attending operation Qian excluded wrist Department moving vein pathway surgery; operation Qian assessment/surgery site assessment wrist Department moving vein conditions insufficient, surgery physician judge to for standard wrist Department moving vein pathway/or select standard junction bit yiwai of parts for surgery; surgery Shi occurred non-expected negative complications, cannot effective completed surgery And said it could not meet before joining the research or patient tracking movement refused to examine the test or measurement

Exclusion Criteria:

  • weak / serious heart failure / unclear / long-term bed rest, internal and external surgery physician preoperative removal of wrist arteriovenous access surgery; preoperative assessment / surgery site evaluation of wrist arteriovenous conditions, the surgeon to determine The standard wrist arteriovenous access and / or the selection of part of the standard joint site for surgery; unintended adverse complications during surgery, can not effectively complete the surgery; within one week after surgery complications, not suitable for tracking exercise or measurement, or before the study The patient indicated that he could not cooperate with the tracking exercise or the measurement and refused to study the trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: arm movement more than a total of at least 30 minutes a day
Using the provided rubber ball grip the ball movement on a daily basis, and grip the ball at a time 3-5 seconds, every 5 minutes, daily at least 6 rounds (for example, according to the daily morning, noon and night-time sports training in the two groups), to reach an arm movement more than a total of at least 30 minutes a day
Other: Systematically intermittent arm exercise
While holding a rubber ball for 5 minutes a day, together with strappy elastic compression arm veinElastic bandages defined for using this research provides of standard bandages, according to research personnel Guide, reached hand elbow near heart end 4 (2~6) cm at of arm local pressure strong 50 mm-Hg (+/-10 mm-Hg) (about equivalent to provides pressure strong 6.67 thousand PA (kPa), also about equivalent to 0.97 PSI (pound per square inch)), to reached 5 minutes arm movement Shi short reduced vein return, promotion pathway vein extended of effect
Other Names:
  • Systematically intermittent arm exercise with local pressure
OTHER: arm movement and local press strength 50 mmHg at the upper arm
Using the provided rubber ball grip the ball movement on a daily basis, and grip the ball at a time 3-5 seconds, every 5 minutes, daily at least 6 rounds (for example, according to the daily morning, noon and night-time sports training in the two groups), to reach an arm movement more than a total of at least 30 minutes a day with Elbow proximal 4 (2~6) local press strength 50 mmHg at the upper arm
Other: Systematically intermittent arm exercise
While holding a rubber ball for 5 minutes a day, together with strappy elastic compression arm veinElastic bandages defined for using this research provides of standard bandages, according to research personnel Guide, reached hand elbow near heart end 4 (2~6) cm at of arm local pressure strong 50 mm-Hg (+/-10 mm-Hg) (about equivalent to provides pressure strong 6.67 thousand PA (kPa), also about equivalent to 0.97 PSI (pound per square inch)), to reached 5 minutes arm movement Shi short reduced vein return, promotion pathway vein extended of effect
Other Names:
  • Systematically intermittent arm exercise with local pressure

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The diameter of each passage of the passage vein (forearm head vein) of the arterial and venous access within three months
Time Frame: Postoperative Three months
Comparison of the various methods to achieve within three months the checkpoint path diameter increase rate (two time points measurement difference).
Postoperative Three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 8, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201701043RINC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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