Back to resultsSystematically Intermittent Arm Exercise for Improving Maturation of Hemodialysis Arteriovenous Shunt: Study Protocol for a Randomized Controlled Trial
Primary Purpose
Systematically Intermittent Arm Exercise for Improving Maturation of Hemodialysis Arteriovenous Shunt
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Systematically intermittent arm exercise
Sponsored by
About this trial
This is an interventional other trial for Systematically Intermittent Arm Exercise for Improving Maturation of Hemodialysis Arteriovenous Shunt
Eligibility Criteria
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.
Sites / Locations
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
arm movement more than a total of at least 30 minutes a day
arm movement and local press strength 50 mmHg at the upper arm
Arm Description
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
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
Outcomes
Primary Outcome Measures
The diameter of each passage of the passage vein (forearm head vein) of the arterial and venous access within three months
Comparison of the various methods to achieve within three months the checkpoint path diameter increase rate (two time points measurement difference).
Secondary Outcome Measures
Full Information
NCT ID
NCT03077815
First Posted
March 8, 2017
Last Updated
May 30, 2022
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03077815
Brief Title
Systematically Intermittent Arm Exercise for Improving Maturation of Hemodialysis Arteriovenous Shunt: Study Protocol for a Randomized Controlled Trial
Official Title
National Taiwan University Hospital
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
July 1, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systematically Intermittent Arm Exercise for Improving Maturation of Hemodialysis Arteriovenous Shunt
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
119 (Actual)
8. Arms, Groups, and Interventions
Arm Title
arm movement more than a total of at least 30 minutes a day
Arm Type
Other
Arm Description
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
Arm Title
arm movement and local press strength 50 mmHg at the upper arm
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Systematically intermittent arm exercise
Other Intervention Name(s)
Systematically intermittent arm exercise with local pressure
Intervention Description
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
Primary Outcome Measure Information:
Title
The diameter of each passage of the passage vein (forearm head vein) of the arterial and venous access within three months
Description
Comparison of the various methods to achieve within three months the checkpoint path diameter increase rate (two time points measurement difference).
Time Frame
Postoperative Three months
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chih-Yang Chan, phd
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
State/Province
No.7, Chung Shan S. Rd
ZIP/Postal Code
10002
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
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Systematically Intermittent Arm Exercise for Improving Maturation of Hemodialysis Arteriovenous Shunt: Study Protocol for a Randomized Controlled Trial
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