RecruitingPhase 1NCT02411773

Sympatholysis in Chronic Kidney Disease

Functional Sympatholysis and Exercise Intolerance in Chronic Kidney Disease

Sponsor

Emory University

Enrollment

110 participants

Start Date

Jun 11, 2015

Study Type

INTERVENTIONAL

Conditions

Chronic Kidney Disease

Summary

The purpose of this study is to find out why patients with chronic kidney disease (CKD) have poor exercise capacity and what causes an increase in blood pressure during exercise (i.e. increased adrenaline levels, or decreased ability of blood vessels to dilate).

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating how exercise affects blood vessel function in patients with chronic kidney disease (CKD), and whether a medication that reduces nerve activity to blood vessels can improve exercise capacity in these patients. **You may be eligible if...** - You are a veteran between 18 and 75 years old - You have Stage 3 or Stage 4 chronic kidney disease, OR you have had a kidney transplant, OR you have no kidney disease and can serve as a healthy comparison participant - You exercise less than 20 minutes twice a week - You are willing and able to follow the study protocol **You may NOT be eligible if...** - Your kidney disease is very severe (very low kidney filtering function) - You have certain blood chemistry imbalances - You currently use drugs or alcohol - You have nerve damage from diabetes - You have severe anemia, heart failure, or symptomatic heart disease - Your blood pressure is too high (above 170/100) or too low (below 100/50) - You are pregnant or planning to become pregnant - You take certain medications such as clonidine or MAO inhibitors - 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

Sodium bicarbonate tablet is 650 mg for one tablet. Oral sodium bicarbonate will be given out as 1300mg-2600mg (2-4 pills) prior to each exercise or stretching session. Serum bicarbonate measurements will be monitored throughout the study (at 2 weeks, then every 2-4 weeks thereafter), and bicarbonate dosages will be adjusted to avoid metabolic alkalosis (serum bicarbonate \> 30).

DRUGPlacebo

2-4 placebo pills will be given out prior to each exercise or stretching session.

BEHAVIORALExercise Training

Exercise training consists of riding a stationary bicycle for 20-45 minutes, 3 times per week, supervised by trained exercise specialists, for 6-12 weeks. The exercise program will follow the guidelines provided by the American College of Sports Medicine (ACSM) for optimizing cardiovascular fitness. Exercise intensity will begin at low levels (50 percent of resting heart rate) and increase to no greater than 80 percent of resting heart rate. Exercise time will progress, depending on subject's progress, from 20 minutes per session at first, to a maximum of 45 minutes. Trained staff members will give instructions throughout each exercise session. Before beginning each exercise session, subjects will be instructed on a warm-up focusing on preparing the legs for activity.

BEHAVIORALControl to Exercise (Stretching)

Stretching exercise will consist of muscle stretching and toning for 20-45 minutes, 3 times per week, supervised by trained exercise specialists, for 6-12 weeks. Trained staff members will guide subjects with the stretching exercises, and activities are designed to increase flexibility and range of motion. Before beginning each stretching exercise session, subjects will be instructed to warm-up.