RecruitingPhase 2NCT05928936

Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease: Sympatholysis in CKD


Sponsor

Emory University

Enrollment

156 participants

Start Date

Nov 11, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The goals of this project are to investigate the mechanisms and potential therapies related to exercise capacity in persons with chronic kidney disease (CKD).


Eligibility

Min Age: 40 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study investigates how the nervous system regulates blood flow to muscles during exercise in people with chronic kidney disease, comparing them to kidney transplant recipients and healthy controls to better understand exercise-related blood flow changes. **You may be eligible if...** - You have moderate-to-severe chronic kidney disease (CKD stage III or IV), or you have received a kidney transplant, or you are a healthy volunteer with normal kidney function - You have high blood pressure - You do not exercise regularly (less than 20 minutes twice a week) **You may NOT be eligible if...** - Your kidney disease is very severe (eGFR below 15) - You have heart failure, a history of heart attack or stroke in the past 6 months - You have diabetic nerve damage or autonomic dysfunction - You are severely anemic (hemoglobin below 10 g/dL) - You take certain blood pressure medications (central alpha-agonists like clonidine) - You have a pacemaker, metal implants, or claustrophobia (as an MRI is required) - You are pregnant or planning to become pregnant - You cannot ride a stationary bicycle Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSodium Bicarbonate

Participants take 650-1300 mg of sodium bicarbonate orally twice daily. Serum bicarbonate levels are measured at baseline and then every 2-4 weeks throughout the trial. Doses will be adjusted or held to avoid metabolic alkalosis.

BEHAVIORALExercise Training

Exercise training consists of progressive, interval-based "Spin" exercise on stationary bicycles three times per week for 12 weeks, led by a certified exercise physiologist. The duration of each session begins at 20 minutes and is increased by 1 to 2 minutes as tolerated to a goal of 45 minutes per session. Exercise intensity begins at low levels (50% of maximal heart rate reserve (HRR)) and increases by 5% every week to a goal of 75% maximal HRR. Each session includes a 5-min warm up, then an interval-based, work-out phase that includes steady up-tempo cadences, sprints, and climbs, followed by a 5-minute cool down.

DRUGPlacebo

Participants take placebo pills to match 650-1300 mg of sodium bicarbonate orally twice daily.


Locations(2)

Emory Clinic

Atlanta, Georgia, United States

Atlanta VA Medical Center

Decatur, Georgia, United States

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NCT05928936


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