Recruiting
Phase 1

Sympatholysis

Sponsor:

Emory University

Code:

NCT02411773

Conditions

Chronic Kidney Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Sodium Bicarbonate

Placebo

Exercise Training

Control to Exercise (Stretching)

Study Details

Brief 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).

Conditions

Chronic Kidney Disease

Study ID

NCT02411773

Start date

Jun 11, 2015

Status verified date

May, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Veterans with Stages III and IV Chronic Kidney Disease (CKD)
  • Kidney transplant recipients with varying degrees of kidney function
  • Veterans 18-75 years old, without kidney disease, as study controls
  • Exercise less than 20 minutes twice per week
  • Willing and able to cooperate with the protocol

Exclusion Criteria:

  • Severe CKD (estimated glomerular filtration rate (eGFR) < 15 cc/minute)
  • Metabolic alkalosis (serum bicarbonate > 28 meq/L)
  • Ongoing drug or alcohol abuse
  • Diabetic neuropathy
  • Any serious systemic disease that might influence survival
  • Severe anemia with hemoglobin (Hbg) level < 10 g/dL
  • Clinical evidence of congestive heart failure or ejection fraction below 35%
  • Symptomatic heart disease determined by prior electrocardiogram, stress test, and/or history
  • Treatment with central alpha agonists (clonidine)
  • Uncontrolled hypertension with blood pressure (BP) greater than 170/100 mmHg
  • Low blood pressure with BP less than 100/50 mmHg
  • Pregnancy or plans to become pregnant
  • Current treatment with monoamine oxidase inhibitors (MAOIs)
  • Inability to exercise on a stationary bicycle

Study Design

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Exercise Training plus Sodium Bicarbonate

Subjects with CKD will undergo exercise training on a stationary bicycle for 20-45 minutes, 3 times per week, for 6-12 weeks. Additionally, subjects will take 1300-2600 mg (2-4 pills) of sodium bicarbonate prior to each exercise session three times a week.

active comparator: Exercise Training plus Placebo

Subjects with CKD will undergo exercise training on a stationary bicycle,for 20-45 minutes, 3 times per week, for 6-12 weeks. Additionally, subjects will take 2-4 placebo tablets prior to each exercise session three times a week.

active comparator: Control to Exercise (Stretching) plus Sodium Bicarbonate

Subjects with CKD will undergo progressive whole body stretching and toning exercises 3 times a week for 20-45 minutes for 6-12 weeks. Additionally, subjects will take 1300-2600 mg (2-4 pills) of sodium bicarbonate prior to each stretching session three times a week.

placebo comparator: Control to Exercise (Stretching) plus Placebo

Subjects with CKD will undergo progressive whole body stretching and toning exercises 3 times a week for 20-45 minutes for 6-12 weeks. Additionally, subjects will take 2-4 placebo tablets prior to each exercise session three times a week.

no intervention: Healthy Control

Healthy subjects without CKD will not receive any interventions.

Interventions

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).

Placebo

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

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.

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.

Primary outcome measure

  • Change in muscle oxygenation after exercise/stretching training [ Time Frame: Baseline, Week 12 ]
  • Change in muscle interstitial pH after exercise/stretching training [ Time Frame: Baseline, Week 12 ]
  • Change in venoconstriction after exercise/stretching training [ Time Frame: Baseline, Week 12 ]

Central Contacts and Locations

Central contacts

Dana DaCosta

404-727-7762drdacos@emory.edu

Jeanie Park, MD

404-321-6111

Locations

Atlanta VA Medical Center

Recruiting

Decatur, Georgia, United States, 30033

Contacts

Dana DaCosta

404-727-7762drdacos@emory.edu

Principal Investigator:

Jeanie Park, MD

More Information

Sponsor

Emory University

Last update posted

May 18, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-05-18.