Exercise and Vascular Function in Chronic Kidney Disease

Chronic Renal Insufficiency Clinical Trial

Official title:

Exercise and Vascular Function in Chronic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02050035
• Other study ID #: KAAP32212114000
• Secondary ID: 1R01HL113514-01A
• Status: Completed
• Phase: Phase 4
• First received: January 28, 2014
• Last updated: August 29, 2017
• Start date: July 2013
• Est. completion date: July 31, 2017

Study information

• Verified date: August 2017
• Source: University of Delaware
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: July 31, 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Renal Insufficiency
• Kidney Diseases
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Other:
• Aerobic Exercise Training
Supervised outpatient moderate to vigorous aerobic training at 60% - 85% heart rate reserve, carried out for 45 minutes, three times per week over a twelve week period.

Locations

Country	Name	City	State
United States	Department of Kinesiology and Applied Physiology, University of Delaware	Newark	Delaware

Sponsors (2)

Lead Sponsor	Collaborator
University of Delaware	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial Function	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.	Change from baseline at 12 weeks
Secondary	Microvascular function	Nitric oxide contribution to cutaneous microvascular vasodilation in response to local heating assessed by microdialysis and laser Doppler flowmetry	Change from baseline at 12 weeks
Secondary	Oxidative stress contribution to vascular dysfunction	Oxidative stress contribution to cutaneous vasodilation dysfunction in response to local heating assessed by microdialysis and laser Doppler flowmetry.	Change from baseline at 12 weeks
Secondary	Endothelial cell oxidative stress	Endothelial cell nitrotyrosine, NADPH oxidase, MnSOD oxidase content obtained from antecubital vein endothelial cells and assessed by fluorescence microscopy.	Changes from baseline at 12 weeks
Secondary	Plasma Oxidized Low Density Lipoprotein	Plasma oxidized low density lipoprotein measured by ELISA	Change from baseline at 12 weeks
Secondary	F2-isoprostanes	Urinary F2-isoprostanes measured by ELISA	Change from baseline at 12 weeks
Secondary	Pulse Wave Analysis	Central blood pressure and augmentation index assessed by oscillometry and radial tonometry	Change from baseline at 12 weeks
Secondary	Arterial Stiffness	Carotid to femoral pulse wave velocity and assessed by tonometry	Change from baseline at 12 weeks
Secondary	Ambulatory Blood Pressure	24 hour blood pressure recorded by oscillometric monitors	Change from baseline at 12 weeks
Secondary	Peak Aerobic Capacity	Peak oxygen uptake (VO2peak/max) during incremental cycling exercise until exhaustion	Change from baseline at 12 weeks
Secondary	Physical Function	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.	Change from baseline at 12 weeks
Secondary	Habitual Physical Activity	Daily average energy expenditure, step count and physical activity intensity level by accelerometry.	Change from baseline at 12 weeks
Secondary	Knee Extensor Strength	Maximal isometric knee extensor strength	Change from baseline at 12 weeks