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

NCT ID: NCT01068314

Last Updated: 2014-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2010-06-30

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.

Conditions

Kidney Failure, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Repetitive arm exercise

Intervention Type: OTHER

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 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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Iowa

OTHER

Sponsor Role: lead

Responsible Party

Bradley S. Dixon

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bradley S Dixon, MD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

University of Iowa General Clinical Research Center

Iowa City, Iowa, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36184076 (View on PubMed)

Other Identifiers

UI200308021

Identifier Type: -

Identifier Source: org_study_id