Sympatholysis in Chronic Kidney Disease

Part of paid clinical trials in Decatur, Georgia.

Sponsor
Emory University
Study ID
NCT02411773
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Sodium Bicarbonate — 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 — DRUG
    2-4 placebo pills will be given out prior to each exercise or stretching session.
  • Exercise Training — 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) — 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.

Study Details

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).

Key Dates

Start date
Jun 11, 2015
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Atlanta VA Medical CenterDecaturGeorgia30033
Dana DaCosta
[email protected]
404-727-7762
Jeanie Park, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Decatur, GA

By condition
Chronic kidney disease
By specialty
NephrologyKidney disease
By research site
Atlanta VA Medical Center· Decatur, GA

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