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RECRUITING
NCT02411773
PHASE1

Sympatholysis in Chronic Kidney Disease

Sponsor: Emory University

View on ClinicalTrials.gov

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).

Official title: Functional Sympatholysis and Exercise Intolerance in Chronic Kidney Disease

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2015-06-11

Completion Date

2027-06

Last Updated

2025-03-05

Healthy Volunteers

Yes

Interventions

DRUG

Sodium 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).

DRUG

Placebo

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

BEHAVIORAL

Exercise 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.

BEHAVIORAL

Control 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.

Locations (1)

Atlanta VA Medical Center

Decatur, Georgia, United States