Chronic Renal Insufficiency
Conditions
Keywords
Exercise Therapy, Endothelium, vascular, Blood Vessels
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.
Interventions
OTHERAerobic 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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Delaware
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Plasma Oxidized Low Density Lipoprotein | Change from baseline at 12 weeks | Plasma oxidized low density lipoprotein measured by ELISA |
| F2-isoprostanes | Change from baseline at 12 weeks | Urinary F2-isoprostanes measured by ELISA |
| Pulse Wave Analysis | Change from baseline at 12 weeks | Central blood pressure and augmentation index assessed by oscillometry and radial tonometry |
| 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 |
| Ambulatory Blood Pressure | Change from baseline at 12 weeks | 24 hour blood pressure recorded by oscillometric monitors |
| Peak Aerobic Capacity | Change from baseline at 12 weeks | Peak oxygen uptake (VO2peak/max) during incremental cycling exercise until exhaustion |
| 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. |
| Habitual Physical Activity | Change from baseline at 12 weeks | Daily average energy expenditure, step count and physical activity intensity level by accelerometry. |
| Knee Extensor Strength | Change from baseline at 12 weeks | Maximal isometric knee extensor strength |
| Arterial Stiffness | Change from baseline at 12 weeks | Carotid to femoral pulse wave velocity and assessed by tonometry |
Countries
United States
Outcome results
None listed