NCT01068314

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 12, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

February 27, 2014

Status Verified

February 1, 2014

Enrollment Period

1.3 years

First QC Date

February 11, 2010

Last Update Submit

February 25, 2014

Conditions

Keywords

EndotheliumVasodilatationVeinComplianceArteriovenous shunt, surgical

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

EXPERIMENTAL

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

No arm exercise

NO INTERVENTION

Time 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.

Repetitive handgrip exercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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.

MeSH Terms

Conditions

Kidney Failure, ChronicAneurysmPatient ComplianceArteriovenous Fistula

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorArteriovenous MalformationsVascular MalformationsCardiovascular AbnormalitiesVascular FistulaCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesFistulaPathological Conditions, Anatomical

Study Officials

  • Bradley S Dixon, MD

    University of Iowa

    PRINCIPAL INVESTIGATOR

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

Locations