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Exercise and Vascular Function in Chronic Kidney Disease

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
David Edwards, University of Delaware
ClinicalTrials.gov Identifier:
NCT02050035
First received: January 28, 2014
Last updated: August 29, 2017
Last verified: August 2017
  Purpose
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 Intervention Phase
Chronic Renal Insufficiency Other: Aerobic Exercise Training Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Exercise and Vascular Function in Chronic Kidney Disease

Resource links provided by NLM:


Further study details as provided by David Edwards, University of Delaware:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Microvascular function [ Time Frame: 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

  • Oxidative stress contribution to vascular dysfunction [ Time Frame: 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.

  • Endothelial cell oxidative stress [ Time Frame: 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.

  • Plasma Oxidized Low Density Lipoprotein [ Time Frame: Change from baseline at 12 weeks ]
    Plasma oxidized low density lipoprotein measured by ELISA

  • F2-isoprostanes [ Time Frame: Change from baseline at 12 weeks ]
    Urinary F2-isoprostanes measured by ELISA

  • Pulse Wave Analysis [ Time Frame: Change from baseline at 12 weeks ]
    Central blood pressure and augmentation index assessed by oscillometry and radial tonometry

  • Arterial Stiffness [ Time Frame: Change from baseline at 12 weeks ]
    Carotid to femoral pulse wave velocity and assessed by tonometry

  • Ambulatory Blood Pressure [ Time Frame: Change from baseline at 12 weeks ]
    24 hour blood pressure recorded by oscillometric monitors

  • Peak Aerobic Capacity [ Time Frame: Change from baseline at 12 weeks ]
    Peak oxygen uptake (VO2peak/max) during incremental cycling exercise until exhaustion

  • Physical Function [ Time Frame: 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.

  • Habitual Physical Activity [ Time Frame: Change from baseline at 12 weeks ]
    Daily average energy expenditure, step count and physical activity intensity level by accelerometry.

  • Knee Extensor Strength [ Time Frame: Change from baseline at 12 weeks ]
    Maximal isometric knee extensor strength


Enrollment: 76
Actual Study Start Date: July 2013
Study Completion Date: July 31, 2017
Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  • Cancer
  • Immunosuppressant or antiretroviral therapy
  • Current tobacco use
  • Pregnancy
  • Hormone replacement therapy
  • Unable to give consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02050035

Locations
United States, Delaware
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
  More Information

Responsible Party: David Edwards, Associate Proffessor, University of Delaware
ClinicalTrials.gov Identifier: NCT02050035     History of Changes
Other Study ID Numbers: KAAP32212114000
1R01HL113514-01A1 ( U.S. NIH Grant/Contract )
364680-6 ( Other Identifier: University of Delaware Institutional Review Board )
Study First Received: January 28, 2014
Last Updated: August 29, 2017

Keywords provided by David Edwards, University of Delaware:
Exercise Therapy
Endothelium, vascular
Blood Vessels

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases

ClinicalTrials.gov processed this record on September 19, 2017