Exercise and Vascular Function in Chronic Kidney Disease

Sponsor
University of Delaware (Other)
Overall Status
Completed
CT.gov ID
NCT02050035
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
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49
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Aerobic Exercise Training
Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
76 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Exercise and Vascular Function in Chronic Kidney Disease
Actual Study Start Date :
Jul 1, 2013
Actual Primary Completion Date :
Jul 1, 2017
Actual Study Completion Date :
Jul 31, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: CKD Aerobic Exercise Training

Chronic Kidney Disease participants randomly allocated to the CKD Exercise arm will receive 12 weeks of Aerobic Exercise Training three times per week.

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.

No Intervention: CKD Control

Chronic Kidney Disease participants allocated to the the CKD Control arm will receive their standard routine care over a 12 week period.

No Intervention: Healthy Control

Healthy participants will act as comparators, they will undergo baseline testing only and will not receive an intervention.

Outcome Measures

Primary Outcome Measures

  1. Endothelial Function [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 Outcome Measures

  1. Microvascular function [Change from baseline at 12 weeks]

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

  2. Oxidative stress contribution to vascular dysfunction [Change from baseline at 12 weeks]

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

  3. Endothelial cell oxidative stress [Changes from baseline at 12 weeks]

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

  4. Plasma Oxidized Low Density Lipoprotein [Change from baseline at 12 weeks]

    Plasma oxidized low density lipoprotein measured by ELISA

  5. F2-isoprostanes [Change from baseline at 12 weeks]

    Urinary F2-isoprostanes measured by ELISA

  6. Pulse Wave Analysis [Change from baseline at 12 weeks]

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

  7. Arterial Stiffness [Change from baseline at 12 weeks]

    Carotid to femoral pulse wave velocity and assessed by tonometry

  8. Ambulatory Blood Pressure [Change from baseline at 12 weeks]

    24 hour blood pressure recorded by oscillometric monitors

  9. Peak Aerobic Capacity [Change from baseline at 12 weeks]

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

  10. Physical Function [Change 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.

  11. Habitual Physical Activity [Change from baseline at 12 weeks]

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

  12. Knee Extensor Strength [Change from baseline at 12 weeks]

    Maximal isometric knee extensor strength

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Kinesiology and Applied Physiology, University of Delaware Newark Delaware United States 19713

Sponsors and Collaborators

  • University of Delaware
  • National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: David Edwards, PhD, University of Delaware

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
David Edwards, Associate Proffessor, University of Delaware
ClinicalTrials.gov Identifier:
NCT02050035
Other Study ID Numbers:
  • KAAP32212114000
  • 1R01HL113514-01A1
  • 364680-6
First Posted:
Jan 30, 2014
Last Update Posted:
Aug 31, 2017
Last Verified:
Aug 1, 2017
Keywords provided by David Edwards, Associate Proffessor, University of Delaware
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 31, 2017