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OpenTrials
Completed

NCT Number: NCT01068314

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

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.

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Key information

Conditions

Kidney Failure, Chronic Aneurysm Arteriovenous Fistula Arteriovenous Malformations Behavior Cardiovascular Abnormalities Cardiovascular Diseases Chronic Disease Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fistula Health Behavior Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Renal Insufficiency Renal Insufficiency, Chronic Treatment Adherence and Compliance Urogenital Diseases Urologic Diseases Vascular Diseases Vascular Fistula Vascular Malformations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa General Clinical Research Center

Iowa City, Iowa, 52242, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Repetitive arm exercise

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.

Primary outcomes

  1. Brachial artery flow-mediated dilatation

    Time frame: 6 weeks

Secondary outcomes

  1. Forearm venous compliance by plethysmography

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

University of Iowa

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2010
First posted
Feb 12, 2010
Registry last updated
Feb 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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