Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease: Sympatholysis in CKD

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT05928936
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Sodium Bicarbonate — DRUG
    Participants take 650-1300 mg of sodium bicarbonate orally twice daily. Serum bicarbonate levels are measured at baseline and then every 2-4 weeks throughout the trial. Doses will be adjusted or held to avoid metabolic alkalosis.
  • Exercise Training — BEHAVIORAL
    Exercise training consists of progressive, interval-based "Spin" exercise on stationary bicycles three times per week for 12 weeks, led by a certified exercise physiologist. The duration of each session begins at 20 minutes and is increased by 1 to 2 minutes as tolerated to a goal of 45 minutes per session. Exercise intensity begins at low levels (50% of maximal heart rate reserve (HRR)) and increases by 5% every week to a goal of 75% maximal HRR. Each session includes a 5-min warm up, then an interval-based, work-out phase that includes steady up-tempo cadences, sprints, and climbs, followed by a 5-minute cool down.
  • Placebo — DRUG
    Participants take placebo pills to match 650-1300 mg of sodium bicarbonate orally twice daily.

Study Details

The goals of this project are to investigate the mechanisms and potential therapies related to exercise capacity in persons with chronic kidney disease (CKD).

Key Dates

Start date
Nov 11, 2022
Status verified
Oct 2025
Primary completion
Jun 1, 2028
Completion
Jun 1, 2028

Study Design

Enrollment
156 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Exercise Training plus Sodium Bicarbonate
    Participants with CKD will undergo exercise training for 20-45 minutes, 3 times per week, for 12 weeks. Additionally, participants take 650-1300 mg of sodium bicarbonate twice daily.
  • Active Comparator: Exercise Training plus Placebo
    Participants with CKD will undergo exercise training for 20-45 minutes, 3 times per week, for 12 weeks. Additionally, participants take placebo tablets to match 650-1300 mg of sodium bicarbonate twice daily.
  • No Intervention: Healthy control
    Baseline measurements in healthy participants without CKD will be measured and compared to participants with CKD. Healthy controls will not receive any interventions.

Primary Outcome Measure

Change in Exercise Capacity [ Time Frame: Baseline, Week 12 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Emory ClinicAtlantaGeorgia30322-
Atlanta VA Medical CenterDecaturGeorgia30033-

Find similar trials in Atlanta, GA

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

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