Focus Chronic Kidney Disease With Hypertension Clinical Trial
— PACEOfficial title:
Exercise as an Adjunct Therapy to Reduce Blood Pressure in Chronic Kidney Disease
| Verified date | March 2017 |
| Source | University of Minnesota - Clinical and Translational Science Institute |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The general objective of the study is to investigate the effect of regular aerobic exercise on resting and 24-hr blood pressure levels in men and women with stage 3-4 kidney disease and hypertension.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | June 2015 |
| Est. primary completion date | June 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - • Non-diabetic and >18 years of age - Diagnosed kidney disease with associated hypertension: - Non-nephrotic range proteinuria at diagnosis - No active glomerular disease or concomitant systemic inflammatory disease (e.g. lupus) - Systolic blood pressure >130 and/or diastolic blood pressure >80 mm Hg (on medication) - An estimated glomerular filtration rate of between 60 ml/min and 15 ml/min. - Individuals must be able to provide informed consent - Perform walking exercise training on a treadmill - Be able to participate in a 12-week supervised exercise program. Exclusion Criteria: - Currently participating in a formal exercise program - Diabetes, active glomerular disease, or systemic inflammatory disease - Requiring dialysis - Have an Hematocrit <27% - Uncontrolled hypertension (>200/110mmHg) - Peripheral vascular disease. - An inability to understand English or give consent. Other exclusion criteria are: any contraindications to exercise testing or training as indicated by the American College of Sports Medicine guidelines such as: Unstable coronary heart disease and symptomatic heart failure, exercise capacity limited by health problems such as angina, severe arthritis, or extreme dyspnea on exertion, progressive neuromuscular disease, pulmonary disease, or having undergone a coronary revascularization within the past 6 months prior to enrollment. |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Minnesota | Minneapolis | Minnesota |
| Lead Sponsor | Collaborator |
|---|---|
| University of Minnesota - Clinical and Translational Science Institute | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | blood pressure | resting and 24-hour ambulatory blood pressure | at week 0 and at week 12 | |
| Secondary | effective vascular compliance | Pulse wave velocity estimated systemic vascular resistance | at week 0 and at week 12 | |
| Secondary | endothelial function | measured by brachial artery flow mediated vasodilation | at week 0 and at week 12 | |
| Secondary | biomarkers associated with blood pressure | Circulating levels of angiotensin 2 Circulating levels of endothelin 1 asymmetric dimethylarginine | at week 0 and at week 12 |