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Effect of Exercise on Endothelial Function and Vascular Compliance in Chronic Kidney Disease

Primary Purpose

Kidney Failure, Chronic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Repetitive arm exercise
Sponsored by
University of Iowa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Kidney Failure, Chronic focused on measuring Endothelium, Vasodilatation, Vein, Compliance, Arteriovenous shunt, surgical

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • University of Iowa General Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Repetitive handgrip exercise

No arm exercise

Arm Description

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.

Time control. Subjects do usual activities without any exercise intervention. Brachial artery endothelial function and venous compliance are tested at baseline and 6 weeks.

Outcomes

Primary Outcome Measures

Brachial artery flow-mediated dilatation

Secondary Outcome Measures

Forearm venous compliance by plethysmography

Full Information

First Posted
February 11, 2010
Last Updated
February 25, 2014
Sponsor
University of Iowa
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1. Study Identification

Unique Protocol Identification Number
NCT01068314
Brief Title
Effect of Exercise on Endothelial Function and Vascular Compliance in Chronic Kidney Disease
Official Title
Effect of Forearm Exercise on Flow Mediated Vasodilation Prior to Arteriovenous Fistula Placement for Hemodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Iowa

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Chronic
Keywords
Endothelium, Vasodilatation, Vein, Compliance, Arteriovenous shunt, surgical

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Repetitive handgrip exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
No arm exercise
Arm Type
No Intervention
Arm Description
Time control. Subjects do usual activities without any exercise intervention. Brachial artery endothelial function and venous compliance are tested at baseline and 6 weeks.
Intervention Type
Other
Intervention Name(s)
Repetitive arm exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Brachial artery flow-mediated dilatation
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Forearm venous compliance by plethysmography
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bradley S Dixon, MD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa General Clinical Research Center
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
36184076
Citation
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.
Results Reference
derived

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Effect of Exercise on Endothelial Function and Vascular Compliance in Chronic Kidney Disease

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