Systematically Intermittent Arm Exercise for Improving Maturation of Hemodialysis Arteriovenous ShuntNCT03077815
Systematically Intermittent Arm Exercise for Improving Maturation of Hemodialysis Arteriovenous Shunt: Study Protocol for a Randomized Controlled Trial
A study testing Systematically intermittent arm exercise in people with Systematically Intermittent Arm Exercise for Improving Maturation of Hemodialysis Arteriovenous Shunt, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Systematically Intermittent Arm Exercise for Improving Maturation of Hemodialysis Arteriovenous Shunt
- What is being tested?
- Systematically intermittent arm exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Apr 2017to 31 Dec 2018
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hospital
Taipei, No.7, Chung Shan S. Rd, 10002
About this study
Official title: 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.
Read the 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
- Being tested
- Systematically intermittent arm exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systematically intermittent arm exerciseOther
Also called Systematically intermittent arm exercise with local pressure
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
| Study group | Role | What they receive |
|---|---|---|
| arm movement more than a total of at least 30 minutes a day | Other | 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 Receives: Other: Systematically intermittent arm exercise |
| arm movement and local press strength 50 mmHg at the upper arm | Other | 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 Receives: Other: Systematically intermittent arm exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Postoperative Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2017
- Study start1 Apr 2017
- Primary completion1 Jul 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systematically Intermittent Arm Exercise for Improving Maturation of Hemodialysis Arteriovenous ShuntStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chih-Yang Chan, phd, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03077815
- Sponsor's protocol ID
- 201701043RINC
- Status last verified
- Dec 2018
- First submitted
- 8 Mar 2017
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen JW, Fu HY, Hii IH, Tseng HW, Chang PY, Chang CH, Chen YS, Hsu RB, Wu IH, Chen YM, Chu TS, Hung KY, Lin SL, Wu KD, Chan CY. A Randomized Trial of Postoperative Handgrip Exercises for Fistula Maturation in Patients With Newly Created Wrist Radiocephalic Arteriovenous Fistulas. Kidney Int Rep. 2022 Dec 24;8(3):566-574. doi: 10.1016/j.ekir.2022.12.019. eCollection 2023 Mar.
PubMed 36938082
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Taiwan University Hospital
- ClinicalTrials.gov ID
- NCT03077815
- Acronym / sponsor ID
- 201701043RINC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 13 Mar 2017 (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.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| arm movement more than a total of at least 30 minutes a day | Other | Other: Systematically intermittent arm exerciseUsing 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 movement and local press strength 50 mmHg at the upper arm | Other | Other: Systematically intermittent arm exerciseUsing 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 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Systematically intermittent arm exerciseAlso: Systematically intermittent arm exercise with local pressureWhile 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 | arm movement and local press strength 50 mmHg at the upper arm, arm movement more than a total of at least 30 minutes a day |
Primary outcome
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).
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 1 Jun 2022.
- Derived from this study: PubMed 36938082Chen JW, Fu HY, Hii IH, Tseng HW, Chang PY, Chang CH, Chen YS, Hsu RB, Wu IH, Chen YM, Chu TS, Hung KY, Lin SL, Wu KD, Chan CY. A Randomized Trial of Postoperative Handgrip Exercises for Fistula Maturation in Patients With Newly Created Wrist Radiocephalic Arteriovenous Fistulas. Kidney Int Rep. 2022 Dec 24;8(3):566-574. doi: 10.1016/j.ekir.2022.12.019. eCollection 2023 Mar.
- Individual participant dataSharing planned: No
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.
Chih-Yang Chan, phd principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systematically intermittent arm exercise in people with Systematically Intermittent Arm Exercise for Improving Maturation of Hemodialysis Arteriovenous Shunt, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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 1 Jun 2022. 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 Taiwan. 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?
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). 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 NCT03077815, which also lists 1 linked publication.
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 1 Jun 2022.