Clinical trial NCT02050035: Exercise and Vascular Function in Chronic Kidney Disease
Official title: Exercise and Vascular Function in Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Renal Insufficiency
Keywords: Exercise Therapy
Endothelium, vascular
Blood Vessels
Lead sponsor: University of Delaware
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2014-01-30
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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

Primary outcomes:
measure: Endothelial Function
timeFrame: Change from baseline at 12 weeks
Secondary outcomes:
measure: Microvascular function
timeFrame: Change from baseline at 12 weeks
measure: Oxidative stress contribution to vascular dysfunction
timeFrame: Change from baseline at 12 weeks
measure: Endothelial cell oxidative stress
timeFrame: Changes from baseline at 12 weeks
measure: Plasma Oxidized Low Density Lipoprotein
timeFrame: Change from baseline at 12 weeks
measure: F2-isoprostanes
timeFrame: Change from baseline at 12 weeks
measure: Pulse Wave Analysis
timeFrame: Change from baseline at 12 weeks
measure: Arterial Stiffness
timeFrame: Change from baseline at 12 weeks
measure: Ambulatory Blood Pressure
timeFrame: Change from baseline at 12 weeks
measure: Peak Aerobic Capacity
timeFrame: Change from baseline at 12 weeks
measure: Physical Function
timeFrame: Change from baseline at 12 weeks
measure: Habitual Physical Activity
timeFrame: Change from baseline at 12 weeks
measure: Knee Extensor Strength
timeFrame: Change from baseline at 12 weeks
Other outcomes:
Locations:
city: Newark
country: United States
facility: Department of Kinesiology and Applied Physiology, University of Delaware
state: Delaware
Study officials:
affiliation: University of Delaware
name: David Edwards, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kirkman DL, Ramick MG, Muth BJ, Stock JM, Townsend RR, Edwards DG. A randomized trial of aerobic exercise in chronic kidney disease: Evidence for blunted cardiopulmonary adaptations. Ann Phys Rehabil Med. 2021 Nov;64(6):101469. doi: 10.1016/j.rehab.2020.101469. Epub 2021 Oct 26.