Arterio-venous FistulaNCT03988270
Prefistula Forearm Exercise in Pts Requiring Chronic HD Therapy
A study testing Exercise in people with Arterio-venous Fistula and Kidney Failure, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
For chronic hemodialysis patients, the creation of a well-functioning arteriovenous (AV) fistula is critical for ensuring that patient receive adequate hemodialysis. Unfortunately, the primary failure rate for AV fistulas after surgery is about 40%, and this percentage has not changed despite a number of trials of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arterio-venous Fistula, Kidney Failure, Hemodialysis Access Failure
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2019to 9 Nov 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for placement of an elective forearm AV fistula for chronic hemodialysis access.
Who cannot join
- The presence of joint or musculoskeletal impairments that prevent the patient from using a handgrip device on a daily basis
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Presurgical Arm Exercises Prior to Creation of a Forearm AV Fistula in Hemodialysis (HD) Patients With End-stage Kidney Disease: A Pilot Study
For chronic hemodialysis patients, the creation of a well-functioning arteriovenous (AV) fistula is critical for ensuring that patient receive adequate hemodialysis. Unfortunately, the primary failure rate for AV fistulas after surgery is about 40%, and this percentage has not changed despite a number of trials of pharmaceutical agents and biologic agents. A key to success in the development of a useable AV fistula is an adequate arterial and venous diameter in the access forearm. Although exercise is commonly used to increase vessel diameter after AV fistula placement, Investigators are unaware of published studies that report on the effect of exercise prior to AV fistula placement to assist with the maturation of a newly created AV fistula. In this pilot trial, the Principal Investigator will evaluate the feasibility and possible benefits of pre-surgical exercise on forearm AV fistulas.
Read the detailed description
The trial is designed to determine if a pre-surgical exercise program will improve the likelihood of a useable forearm AV fistula. In this pilot study, the feasibility of the proposed intervention will be assessed in terms of both patient acceptability and patient outcomes. In addition, results from this feasibility study will be used to help determine power calculations for a full-scale trial.
Patients will be eligible for this pilot clinical trial if scheduled for placement of an elective forearm AV fistula for chronic hemodialysis access. Patients will be randomized using a random number generator to either the intervention or the control group. The intervention group will be instructed in the use of hand grip with built in digital counter. These instructions will include the use of the hand grip on a daily basis with an increasing number of hand grip squeezes to be performed each week up until the time of fistula placement.
Patients in the control group will not receive any pre-surgical instructions for exercise in the access arm. In both groups, patients will be provided with post-surgical instructions on the use of a squeeze ball on a daily basis once the steri-strips from the surgical site have fallen off.
- Being tested
- Exercise
- Keywords
- Hemodialysis, Fistula, Access Failure, Hemodialysis Fistula Creation
- Medical subject headings
- Arteriovenous Fistula, Renal Insufficiency, Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Participant randomized to an exercise protocol using a hand grip device that is used on a daily basis. Participant will be encouraged to increase the number of repetitions used by the hand grip device during the course of the trial
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Participant randomized to an exercise protocol using a hand grip device that is used on a daily basis. Participant will be encouraged to increase the number of repetitions used by the hand grip device during the course of the trial Receives: Other: Exercise |
| Control | No intervention | Participants in the control group will not receive any pre-surgical instructions for exercise in the access arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with fistula usable without intervention
Fistula usability will be measured by the use of the AV fistula for two needle cannulation for chronic dialysis sessions within 12 weeks after surgical creation.
Measured: Up to 12 weeks after surgical creation of the AV fistula
Number of participants with fistula usable with intervention
Fistula usability will be measured by the use of the AV fistula for two needle cannulation for chronic dialysis sessions within 12 weeks after surgical creation.
Measured: Up to 12 weeks after surgical creation of the AV fistula
Number of participants with fistula not usable
Fistula usability will be measured by the use of the AV fistula for two needle cannulation for chronic dialysis sessions within 12 weeks after surgical creation.
Measured: Up to 12 weeks after surgical creation of the AV fistula
Secondary outcomes (7)
Mean Number of hand grips per day
Measured: Up to 8 weeks after start of the intervention
Mean Number of days hand grips performed
Measured: Up to 8 weeks after start of the intervention
Total mean number of hand grip repetitions performed
Measured: Up to 8 weeks after start of the intervention
Cephalic Vein Doppler measurement
The diameter of the vessel in centimeters will be measured using a Duplex Doppler.
Measured: Up to 8 weeks after start of the intervention
Basilic Vein Doppler measurement
The diameter of the vessel in centimeters will be measured using a Duplex Doppler.
Measured: Up to 8 weeks after start of the intervention
Median Cubital Doppler measurement
The diameter of the vessel in centimeters will be measured using a Duplex Doppler.
Measured: Up to 8 weeks after start of the intervention
Radial Artery Doppler measurement
The diameter of the vessel in centimeters will be measured using a Duplex Doppler.
Measured: Up to 8 weeks after start of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study start17 Jun 2019
- Primary completion15 Sep 2021
- Study completion9 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterio-venous FistulaStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized study with two arms: Intervention arm with a pre-fistula placement exercise program versus a control arm with no prefistula placement exercise
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Rocco, MD, MSCE, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03988270
- Sponsor's protocol ID
- IRB00058671
- Status last verified
- Jun 2021
- First submitted
- 12 Jun 2019
- Last updated
- 10 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Presurgical Arm Exercises Prior to Creation of a Forearm AV Fistula in Hemodialysis (HD) Patients With End-stage Kidney Disease: A Pilot Study
- ClinicalTrials.gov ID
- NCT03988270
- Acronym / sponsor ID
- IRB00058671
- Keywords
- Hemodialysis, Fistula, Access Failure, Hemodialysis Fistula Creation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 17 Jun 2019 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 9 Nov 2021 (actual)
- First posted
- 17 Jun 2019 (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.
For chronic hemodialysis patients, the creation of a well-functioning arteriovenous (AV) fistula is critical for ensuring that patient receive adequate hemodialysis. Unfortunately, the primary failure rate for AV fistulas after surgery is about 40%, and this percentage has not changed despite a number of trials of pharmaceutical agents and biologic agents. A key to success in the development of a useable AV fistula is an adequate arterial and venous diameter in the access forearm. Although exercise is commonly used to increase vessel diameter after AV fistula placement, Investigators are unaware of published studies that report on the effect of exercise prior to AV fistula placement to assist with the maturation of a newly created AV fistula. In this pilot trial, the Principal Investigator will evaluate the feasibility and possible benefits of pre-surgical exercise on forearm AV fistulas.
Detailed description
The trial is designed to determine if a pre-surgical exercise program will improve the likelihood of a useable forearm AV fistula. In this pilot study, the feasibility of the proposed intervention will be assessed in terms of both patient acceptability and patient outcomes. In addition, results from this feasibility study will be used to help determine power calculations for a full-scale trial.
Patients will be eligible for this pilot clinical trial if scheduled for placement of an elective forearm AV fistula for chronic hemodialysis access. Patients will be randomized using a random number generator to either the intervention or the control group. The intervention group will be instructed in the use of hand grip with built in digital counter. These instructions will include the use of the hand grip on a daily basis with an increasing number of hand grip squeezes to be performed each week up until the time of fistula placement.
Patients in the control group will not receive any pre-surgical instructions for exercise in the access arm. In both groups, patients will be provided with post-surgical instructions on the use of a squeeze ball on a daily basis once the steri-strips from the surgical site have fallen off.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized study with two arms: Intervention arm with a pre-fistula placement exercise program versus a control arm with no prefistula placement exercise
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: ExerciseParticipant randomized to an exercise protocol using a hand grip device that is used on a daily basis. Participant will be encouraged to increase the number of repetitions used by the hand grip device during the course of the trial |
| Control | No intervention | –Participants in the control group will not receive any pre-surgical instructions for exercise in the access arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Scheduled for placement of an elective forearm AV fistula for chronic hemodialysis access.
Key exclusion criteria (1 listed)
- The presence of joint or musculoskeletal impairments that prevent the patient from using a handgrip device on a daily basis
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 |
|---|---|---|
| ExerciseParticipant randomized to an exercise protocol using a hand grip device that is used on a daily basis. Participant will be encouraged to increase the number of repetitions used by the hand grip device during the course of the trial | Other | Exercise |
Primary outcome
Number of participants with fistula usable without intervention
Time frame: Up to 12 weeks after surgical creation of the AV fistula
Fistula usability will be measured by the use of the AV fistula for two needle cannulation for chronic dialysis sessions within 12 weeks after surgical creation.
Number of participants with fistula usable with intervention
Time frame: Up to 12 weeks after surgical creation of the AV fistula
Fistula usability will be measured by the use of the AV fistula for two needle cannulation for chronic dialysis sessions within 12 weeks after surgical creation.
Number of participants with fistula not usable
Time frame: Up to 12 weeks after surgical creation of the AV fistula
Fistula usability will be measured by the use of the AV fistula for two needle cannulation for chronic dialysis sessions within 12 weeks after surgical creation.
7 secondary outcomes
Mean Number of hand grips per day
Time frame: Up to 8 weeks after start of the intervention
Mean Number of days hand grips performed
Time frame: Up to 8 weeks after start of the intervention
Total mean number of hand grip repetitions performed
Time frame: Up to 8 weeks after start of the intervention
Cephalic Vein Doppler measurement
Time frame: Up to 8 weeks after start of the intervention
Basilic Vein Doppler measurement
Time frame: Up to 8 weeks after start of the intervention
Median Cubital Doppler measurement
Time frame: Up to 8 weeks after start of the intervention
Radial Artery Doppler measurement
Time frame: Up to 8 weeks after start of the intervention
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 10 Jan 2022.
- Individual participant dataSharing planned: No
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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.
Michael Rocco, MD, MSCE principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Arterio-venous Fistula and Kidney Failure, run by Wake Forest University Health Sciences at 1 site in United States.
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 10 Jan 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 United States. 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?
Number of participants with fistula usable without intervention (time frame: Up to 12 weeks after surgical creation of the AV fistula). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jan 2022.