Comparing exercise training and stretching, with sodium bicarbonate or placebo, for exercise intolerance in chronic kidney disease

• Sodium Bicarbonate

  Intervention · DRUG

  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

  Intervention · DRUG

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

• Exercise Training

  Intervention · BEHAVIORAL

  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)

  Intervention · BEHAVIORAL

  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.

Official title

Functional Sympatholysis and Exercise Intolerance in Chronic Kidney Disease

Sponsor

Emory University

Conditions

Chronic Kidney Disease

Enrolling

110 people

Starts

2015-06-11

Est. completion

2027-06

Design

Open-label, randomized, factorial, Phase 1

Record

View on ClinicalTrials.gov ↗

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