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

Kidney Failure, Chronic Clinical Trial

Official title:

Effect of Forearm Exercise on Flow Mediated Vasodilation Prior to Arteriovenous Fistula Placement for Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01068314
• Other study ID #: UI200308021
• Status: Completed
• Phase: N/A
• First received: February 11, 2010
• Last updated: February 25, 2014
• Start date: January 2007
• Est. completion date: June 2010

Study information

• Verified date: February 2014
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2010
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

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.

Locations

Country	Name	City	State
United States	University of Iowa General Clinical Research Center	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
University of Iowa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brachial artery flow-mediated dilatation		6 weeks	No
Secondary	Forearm venous compliance by plethysmography		6 weeks	No