ENdothelial DysfUnction in Renal Disease and Exercise Training

Study Overview
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Brief Summary
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Chronic kidney disease (CKD) is a prevalent disorder and a major health concern. Cardiovascular disease is the most prevailing and life-threatening complication observed in patients with CKD. The diagnosis of CKD places a patient at the highest cardiovascular risk level irrespective of the stage of renal decline. Therefore, fatal cardiovascular events are more likely to occur than the evolution to final stages of kidney disease with the need for dialysis. Counter intuitively, treatment of classical cardiovascular risk factors does not affect cardiovascular prognosis in CKD, which suggests that the missing link between these two entities has not been elucidated yet. In the present project, the investigators focus on endothelial dysfunction in patients with CKD. Endothelial dysfunction precedes overt atherosclerotic changes by many years. In the absence of structural changes, endothelial dysfunction is still reversible, which offers therapeutic perspectives to tackle the progression towards atherosclerosis in an early stage. The purpose of this study is to determine whether an exercise training program is effective in ameliorating endothelial dysfunction in patients with chronic kidney disease.

Official Title
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Effect of a 3-month Aerobic Training Program on Endothelial Function in Mild-to-moderate CKD: a Randomized Controlled Trial

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Behavioral: Exercise Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with CKD stage 3-4 (eGFR (15-59 ml/min/1.73m2) without cardiovascular disease. Exclusion Criteria: patients < 18 years pregnancy warfarin therapy glucocorticoid therapy clinically active malignant disease heart failure (ejection fraction < 50%) peripheral vascular disease, defined as a history of intermittent claudication, abnormal peripheral angiography or Doppler ultrasound, lower limb artery bypass surgery/angioplasty/stenting or non-traumatic lower extremity amputation cerebrovascular disease, defined as a history of transient ischemic attack (TIA) or stroke, significant stenosis of the A. carotis on ultrasound/CT angiography or carotid endarterectomy/stenting coronary artery disease (CAD), defined as a history of myocardial infarction, coronary artery angioplasty/stenting/bypass surgery, significant structural coronary lesions on angiography or high suspicion of CAD on a maximal exercise test

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br> | |
| Experimental: Exercise Training<br> | Behavioral: Exercise Training<br>* Home-based training programme consisting of daily 4x10 minutes physical exercise on a magnetically braked bicycle at a heart rate corresponding to 80-90% of the heart rate achieved at the anaerobic threshold.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in brachial artery flow-mediated dilation (FMD= percentage constriction from baseline diameter to minimal occlusion diameter) |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in peak oxygen consumption (ml/kg/min) as marker of aerobic capacity |  | 3 months | 
| change in aortic-femoral pulse wave velocity (m/s) as a marker of arterial stiffness |  | 3 months | 
| change in augmentation index (%) as a marker of arterial stiffness |  | 3 months | 
| change in Intima Media Thickness (µm) of the right common carotid artery |  | 3 months |