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ENdothelial DysfUnction in Renal Disease and Exercise Training

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02209402
Acronym
Endure
Enrollment
40
Registered
2014-08-05
Start date
2012-04-30
Completion date
2014-05-31
Last updated
2014-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease

Brief summary

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.

Interventions

BEHAVIORALExercise Training

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.

Sponsors

Universiteit Antwerpen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change in brachial artery flow-mediated dilation (FMD= percentage constriction from baseline diameter to minimal occlusion diameter)3 months

Secondary

MeasureTime frame
change in peak oxygen consumption (ml/kg/min) as marker of aerobic capacity3 months
change in aortic-femoral pulse wave velocity (m/s) as a marker of arterial stiffness3 months
change in augmentation index (%) as a marker of arterial stiffness3 months
change in Intima Media Thickness (µm) of the right common carotid artery3 months

Other

MeasureTime frame
change in circulating endothelial progenitor cells (cells/1 million CD45+ events)3 months
change in migratory function of circulating angiogenic cells3 months

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026