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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bradley S. Dixon, University of Iowa
ClinicalTrials.gov Identifier:
NCT01068314
First received: February 11, 2010
Last updated: February 25, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Kidney Failure, Chronic
Other: Repetitive arm exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Effect of Forearm Exercise on Flow Mediated Vasodilation Prior to Arteriovenous Fistula Placement for Hemodialysis

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • Brachial artery flow-mediated dilatation [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Forearm venous compliance by plethysmography [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: January 2007
Study Completion Date: June 2010
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Repetitive handgrip exercise
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.
Other: Repetitive arm exercise
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.
No Intervention: No arm exercise
Time control. Subjects do usual activities without any exercise intervention. Brachial artery endothelial function and venous compliance are tested at baseline and 6 weeks.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01068314

Locations
United States, Iowa
University of Iowa General Clinical Research Center
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Investigators
Principal Investigator: Bradley S Dixon, MD University of Iowa
  More Information

No publications provided

Responsible Party: Bradley S. Dixon, Associate Professor of Medicine, University of Iowa
ClinicalTrials.gov Identifier: NCT01068314     History of Changes
Other Study ID Numbers: UI200308021
Study First Received: February 11, 2010
Last Updated: February 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Iowa:
Endothelium
Vasodilatation
Vein
Compliance
Arteriovenous shunt, surgical

Additional relevant MeSH terms:
Arteriovenous Fistula
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities
Fistula
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 24, 2014