Effect of Exercise on Endothelial Function and Vascular Compliance in Chronic Kidney Disease
Effect of Forearm Exercise on Flow Mediated Vasodilation Prior to Arteriovenous Fistula Placement for Hemodialysis
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 11, 2010
CompletedFirst Posted
Study publicly available on registry
February 12, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedFebruary 27, 2014
February 1, 2014
1.3 years
February 11, 2010
February 25, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Brachial artery flow-mediated dilatation
6 weeks
Secondary Outcomes (1)
Forearm venous compliance by plethysmography
6 weeks
Study Arms (2)
Repetitive handgrip exercise
EXPERIMENTALAfter 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.
No arm exercise
NO INTERVENTIONTime control. Subjects do usual activities without any exercise intervention. Brachial artery endothelial function and venous compliance are tested at baseline and 6 weeks.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Iowa General Clinical Research Center
Iowa City, Iowa, 52242, United States
Related Publications (1)
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.
PMID: 36184076DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bradley S Dixon, MD
University of Iowa
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
February 11, 2010
First Posted
February 12, 2010
Study Start
January 1, 2007
Primary Completion
May 1, 2008
Study Completion
June 1, 2010
Last Updated
February 27, 2014
Record last verified: 2014-02