Exercise and Vascular Function in Chronic Kidney Disease

University of Delaware

Status and phase: Completed; Phase 4

Conditions: Chronic Renal Insufficiency

Treatments: Other: Aerobic Exercise Training

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02050035

364680-6 (Other Identifier)

1R01HL113514-01A1 (U.S. NIH Grant/Contract)

KAAP32212114000

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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76 participants in 3 patient groups

CKD Aerobic Exercise Training

Experimental group

Description:

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

Treatment:

Other: Aerobic Exercise Training

CKD Control

No Intervention group

Description:

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

Healthy Control

No Intervention group

Description:

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