MedPath

Exercise and Vascular Function in Chronic Kidney Disease

Phase 4
Completed
Conditions
Chronic Renal Insufficiency
Interventions
Other: Aerobic Exercise Training
Registration Number
NCT02050035
Lead Sponsor
University of Delaware
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
76
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
  • Cancer
  • Immunosuppressant or antiretroviral therapy
  • Current tobacco use
  • Pregnancy
  • Hormone replacement therapy
  • Unable to give consent

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
CKD Aerobic Exercise TrainingAerobic Exercise TrainingChronic Kidney Disease participants randomly allocated to the CKD Exercise arm will receive 12 weeks of Aerobic Exercise Training three times per week.
Primary Outcome Measures
NameTimeMethod
Endothelial FunctionChange 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 Outcome Measures
NameTimeMethod
Arterial StiffnessChange from baseline at 12 weeks

Carotid to femoral pulse wave velocity and assessed by tonometry

Microvascular functionChange from baseline at 12 weeks

Nitric oxide contribution to cutaneous microvascular vasodilation in response to local heating assessed by microdialysis and laser Doppler flowmetry

Pulse Wave AnalysisChange from baseline at 12 weeks

Central blood pressure and augmentation index assessed by oscillometry and radial tonometry

Oxidative stress contribution to vascular dysfunctionChange from baseline at 12 weeks

Oxidative stress contribution to cutaneous vasodilation dysfunction in response to local heating assessed by microdialysis and laser Doppler flowmetry.

Endothelial cell oxidative stressChanges from baseline at 12 weeks

Endothelial cell nitrotyrosine, NADPH oxidase, MnSOD oxidase content obtained from antecubital vein endothelial cells and assessed by fluorescence microscopy.

Plasma Oxidized Low Density LipoproteinChange from baseline at 12 weeks

Plasma oxidized low density lipoprotein measured by ELISA

F2-isoprostanesChange from baseline at 12 weeks

Urinary F2-isoprostanes measured by ELISA

Ambulatory Blood PressureChange from baseline at 12 weeks

24 hour blood pressure recorded by oscillometric monitors

Peak Aerobic CapacityChange from baseline at 12 weeks

Peak oxygen uptake (VO2peak/max) during incremental cycling exercise until exhaustion

Physical FunctionChange from baseline at 12 weeks

Dexterity by the '9-Hole Peg Test'; Endurance by the '2 Minute Walk Endurance Test'; locomotion by the '4 Meter Gait Speed Test'; isometric handgrip strength test by handgrip dynamometry.

Knee Extensor StrengthChange from baseline at 12 weeks

Maximal isometric knee extensor strength

Habitual Physical ActivityChange from baseline at 12 weeks

Daily average energy expenditure, step count and physical activity intensity level by accelerometry.

Trial Locations

Locations (1)

Department of Kinesiology and Applied Physiology, University of Delaware

🇺🇸

Newark, Delaware, United States

© Copyright 2025. All Rights Reserved by MedPath