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Clinical Trials/NCT02050035
NCT02050035
Completed
Phase 4

Exercise and Vascular Function in Chronic Kidney Disease

University of Delaware1 site in 1 country76 target enrollmentJuly 2013

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Chronic Renal Insufficiency
Sponsor
University of Delaware
Enrollment
76
Locations
1
Primary Endpoint
Endothelial Function
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

The purpose of this study is to investigate the effects of 12 weeks of aerobic exercise training on blood vessel function in Stages 1-4 Chronic Kidney Disease.

Detailed Description

The endothelium lines the inside of the blood vessels. A healthy endothelial lining acts as a defense mechanism against vascular injury, mediating vascular tone, vascular structure, and blood-vessel wall relations. Endothelial dysfunction marks the occurrence of cardiovascular injuries and is a critical step in the development of cardiovascular disease. Individuals with Chronic Kidney Disease (CKD) have an increased risk of cardiovascular disease and this may be related to poor blood vessel function. Interventions to improve blood vessel function in CKD are needed. Exercise training has been shown to improve blood vessel function in older subjects and those with heart disease but this has not been investigated in CKD. The National Kidney Foundation recommends exercise for dialysis patients to reduce cardiovascular risk however there is very little data regarding the benefits of exercise in earlier stages of CKD. The purpose of this study is to determine the effect of 12 weeks of exercise training on blood vessel function in moderate to severe CKD.

Registry
clinicaltrials.gov
Start Date
July 2013
End Date
July 31, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

David Edwards

Associate Proffessor

University of Delaware

Eligibility Criteria

Inclusion Criteria

  • CKD Exercise and CKD Control Arms: Stage 1 - 4 Chronic Kidney Disease (eGFR 15 - 90 ml/min/1.73m2)
  • Healthy Control Arm: eGFR \> 90 ml/min/1.73m2)

Exclusion Criteria

  • History of cardiovascular disease
  • Uncontrolled hypertension
  • Lung disease
  • Liver disease
  • Immunosuppressant or antiretroviral therapy
  • Current tobacco use
  • Pregnancy
  • Hormone replacement therapy
  • Unable to give consent

Outcomes

Primary Outcomes

Endothelial Function

Time Frame: Change from baseline at 12 weeks

Conduit artery endothelial function assessed by brachial artery flow mediated dilation; Microvascular endothelial function assessed by cutaneous vasodilation in response to local heating measured by microdialysis and laser Doppler flowmetry.

Secondary Outcomes

  • Arterial Stiffness(Change from baseline at 12 weeks)
  • Microvascular function(Change from baseline at 12 weeks)
  • Pulse Wave Analysis(Change from baseline at 12 weeks)
  • Oxidative stress contribution to vascular dysfunction(Change from baseline at 12 weeks)
  • Endothelial cell oxidative stress(Changes from baseline at 12 weeks)
  • Plasma Oxidized Low Density Lipoprotein(Change from baseline at 12 weeks)
  • F2-isoprostanes(Change from baseline at 12 weeks)
  • Ambulatory Blood Pressure(Change from baseline at 12 weeks)
  • Peak Aerobic Capacity(Change from baseline at 12 weeks)
  • Physical Function(Change from baseline at 12 weeks)
  • Knee Extensor Strength(Change from baseline at 12 weeks)
  • Habitual Physical Activity(Change from baseline at 12 weeks)

Study Sites (1)

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