Skip to main content
OpenTrials
Completed

NCT Number: NCT02050035

Exercise and Vascular Function in Chronic Kidney Disease

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Renal Insufficiency Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Kinesiology and Applied Physiology, University of Delaware

Newark, Delaware, 19713, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aerobic exercise training

Other

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.

Primary outcomes

  1. 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

  1. 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

  2. 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.

  3. 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.

  4. Plasma Oxidized Low Density Lipoprotein

    Time frame: Change from baseline at 12 weeks

    Plasma oxidized low density lipoprotein measured by ELISA

  5. F2-isoprostanes

    Time frame: Change from baseline at 12 weeks

    Urinary F2-isoprostanes measured by ELISA

  6. Pulse Wave Analysis

    Time frame: Change from baseline at 12 weeks

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

  7. Arterial Stiffness

    Time frame: Change from baseline at 12 weeks

    Carotid to femoral pulse wave velocity and assessed by tonometry

  8. Ambulatory Blood Pressure

    Time frame: Change from baseline at 12 weeks

    24 hour blood pressure recorded by oscillometric monitors

  9. Peak Aerobic Capacity

    Time frame: Change from baseline at 12 weeks

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

  10. 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.

  11. Habitual Physical Activity

    Time frame: Change from baseline at 12 weeks

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

  12. Knee Extensor Strength

    Time frame: Change from baseline at 12 weeks

    Maximal isometric knee extensor strength

Sponsors and collaborators

Lead sponsor

University of Delaware

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jan 30, 2014
Registry last updated
Aug 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.