Kidney Failure, ChronicNCT01068314
Effect of Exercise on Endothelial Function and Vascular Compliance in Chronic Kidney Disease
A study testing Repetitive arm exercise in people with Kidney Failure, Chronic, run by University of Iowa at 1 site in United States.
Trial summary
The study hypothesis is that 6 weeks of repetitive handgrip exercise will improve endothelial function and venous compliance in pre-dialysis patients with an estimated glomerular filtration rate of less than or equal to 20 ml/min. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Chronic
- What is being tested?
- Repetitive arm exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Jun 2010
- 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
- Age exceeding the age of majority (18 years of age).
- Chronic renal failure with a calculated GFR (MDRD equation) less than or equal to 20 ml/min
- Eligible for creation of an arteriovenous fistula for the purpose of hemodialysis.
- The subject is expected to stay within driving distance of study site for at least 4 months.
- The subject's physician(s) will allow the patient to participate.
- Ability to give informed consent.
Who cannot join
- Unstable angina.
- Uncontrolled hypertension (resting blood pressure >170 systolic or >100 diastolic).
- Musculoskeletal or neurologic problem that prevents arm exercise.
- Currently functioning arteriovenous access in the same arm as the planned new fistula.
- Subjects who are eligible to participate in the ongoing DAC fistula trial.
- Planned new access surgery in less than 6 weeks
- Anticipated non-compliance with medical care based on physician judgment.
- Patient refusal.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa General Clinical Research Center
Iowa City, Iowa, 52242
About this study
Official title: Effect of Forearm Exercise on Flow Mediated Vasodilation Prior to Arteriovenous Fistula Placement for Hemodialysis
The study hypothesis is that 6 weeks of repetitive handgrip exercise will improve endothelial function and venous compliance in pre-dialysis patients with an estimated glomerular filtration rate of less than or equal to 20 ml/min. If proven correct then arm exercise might be useful to improve the success rate for a surgically created arteriovenous fistula in the forearm to become usable as a vascular access for hemodialysis.
Read the detailed description
An arteriovenous fistula (AVF) is the optimal vascular access for chronic hemodialysis. However, AVFs frequently fail to mature. Better strategies are needed to promote AVF maturation. Successful AVF maturation involves arterial and venous dilation. Arterial dilation depends on endothelial release of nitric oxide which can be measured by brachial artery flow-mediated dilation (FMD) and has been reported to predict successful AVF maturation. Venous dilation depends on venous compliance which can be measured by venous plethysmography and is also predictive of successful AVF maturation. Endothelial function is impaired in patients with chronic kidney disease (CKD). Aerobic exercise has been reported to improve endothelial function and venous compliance but it has not been studied in the pre-dialysis patient. To address this question we will determine whether 6 weeks of repetitive handgrip exercise with upper arm venous compression can improve brachial artery endothelial function or venous compliance in pre-dialysis patients with an estimated glomerular filtration rate of less than or equal to 20 ml/min.
- Conditions
- Kidney Failure, Chronic
- Being tested
- Repetitive arm exercise
- Keywords
- Endothelium, Vasodilatation, Vein, Compliance, Arteriovenous shunt, surgical
- Medical subject headings
- Kidney Failure, Chronic, Aneurysm, Patient Compliance, Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive arm exerciseOther
After baseline testing and randomization, subjects in this group are instructed to perform repetitive handgrip exercise with an upper arm compression band until arm fatigue occurs. After resting 1 minute this exercise is repeated 9 times daily for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Repetitive handgrip exercise | Experimental | After baseline testing and randomization, subjects in this group are instructed to perform the intervention: daily repetitive handgrip exercise with upper arm compression band. Brachial artery endothelial function and venous compliance are tested at baseline and 6 weeks. Receives: Other: Repetitive arm exercise |
| No arm exercise | No intervention | Time control. Subjects do usual activities without any exercise intervention. Brachial artery endothelial function and venous compliance are tested at baseline and 6 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brachial artery flow-mediated dilatation
Measured: 6 weeks
Secondary outcomes (1)
Forearm venous compliance by plethysmography
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2010 (estimated)
- Study startJan 2007
- Primary completionMay 2008
- Study completionJun 2010
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 Kidney Failure, ChronicStudies of the same condition, open and under way.
- More trials run by University of IowaThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bradley S. Dixon, University of Iowa
- Investigators
- Bradley S Dixon, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01068314
- Sponsor's protocol ID
- UI200308021
- Status last verified
- Feb 2014
- First submitted
- 11 Feb 2010
- Last updated
- 27 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Nantakool S, Reanpang T, Prasannarong M, Pongtam S, Rerkasem K. Upper limb exercise for arteriovenous fistula maturation in people requiring permanent haemodialysis access. Cochrane Database Syst Rev. 2022 Oct 3;10(10):CD013327. doi: 10.1002/14651858.CD013327.pub2.
PubMed 36184076
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Forearm Exercise on Flow Mediated Vasodilation Prior to Arteriovenous Fistula Placement for Hemodialysis
- ClinicalTrials.gov ID
- NCT01068314
- Acronym / sponsor ID
- UI200308021
- Conditions
- Kidney Failure, Chronic
- Keywords
- Endothelium, Vasodilatation, Vein, Compliance, Arteriovenous shunt, surgical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- May 2008 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 12 Feb 2010 (estimated)
- 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.
The study hypothesis is that 6 weeks of repetitive handgrip exercise will improve endothelial function and venous compliance in pre-dialysis patients with an estimated glomerular filtration rate of less than or equal to 20 ml/min. If proven correct then arm exercise might be useful to improve the success rate for a surgically created arteriovenous fistula in the forearm to become usable as a vascular access for hemodialysis.
Detailed description
An arteriovenous fistula (AVF) is the optimal vascular access for chronic hemodialysis. However, AVFs frequently fail to mature. Better strategies are needed to promote AVF maturation. Successful AVF maturation involves arterial and venous dilation. Arterial dilation depends on endothelial release of nitric oxide which can be measured by brachial artery flow-mediated dilation (FMD) and has been reported to predict successful AVF maturation. Venous dilation depends on venous compliance which can be measured by venous plethysmography and is also predictive of successful AVF maturation. Endothelial function is impaired in patients with chronic kidney disease (CKD). Aerobic exercise has been reported to improve endothelial function and venous compliance but it has not been studied in the pre-dialysis patient. To address this question we will determine whether 6 weeks of repetitive handgrip exercise with upper arm venous compression can improve brachial artery endothelial function or venous compliance in pre-dialysis patients with an estimated glomerular filtration rate of less than or equal to 20 ml/min.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Repetitive handgrip exercise | Experimental | Other: Repetitive arm exerciseAfter baseline testing and randomization, subjects in this group are instructed to perform the intervention: daily repetitive handgrip exercise with upper arm compression band. Brachial artery endothelial function and venous compliance are tested at baseline and 6 weeks. |
| No arm exercise | No intervention | –Time control. Subjects do usual activities without any exercise intervention. Brachial artery endothelial function and venous compliance are tested at baseline and 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age exceeding the age of majority (18 years of age).
- Chronic renal failure with a calculated GFR (MDRD equation) less than or equal to 20 ml/min
- Eligible for creation of an arteriovenous fistula for the purpose of hemodialysis.
- The subject is expected to stay within driving distance of study site for at least 4 months.
- The subject's physician(s) will allow the patient to participate.
Key exclusion criteria (8 listed)
- Unstable angina.
- Uncontrolled hypertension (resting blood pressure >170 systolic or >100 diastolic).
- Musculoskeletal or neurologic problem that prevents arm exercise.
- Currently functioning arteriovenous access in the same arm as the planned new fistula.
- Subjects who are eligible to participate in the ongoing DAC fistula 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 |
|---|---|---|
| Repetitive arm exerciseAfter baseline testing and randomization, subjects in this group are instructed to perform repetitive handgrip exercise with an upper arm compression band until arm fatigue occurs. After resting 1 minute this exercise is repeated 9 times daily for 6 weeks. | Other | Repetitive handgrip exercise |
Primary outcome
Brachial artery flow-mediated dilatation
Time frame: 6 weeks
1 secondary outcome
Forearm venous compliance by plethysmography
Time frame: 6 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 27 Feb 2014.
- Derived from this study: PubMed 36184076Nantakool S, Reanpang T, Prasannarong M, Pongtam S, Rerkasem K. Upper limb exercise for arteriovenous fistula maturation in people requiring permanent haemodialysis access. Cochrane Database Syst Rev. 2022 Oct 3;10(10):CD013327. doi: 10.1002/14651858.CD013327.pub2.
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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.
Bradley S Dixon, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive arm exercise in people with Kidney Failure, Chronic, run by University of Iowa 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 6 inclusion and 8 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 27 Feb 2014. 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?
Brachial artery flow-mediated dilatation (time frame: 6 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 NCT01068314, 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 27 Feb 2014.