Only 87 spots left

~87 spots leftby Jun 2028

Exercise for Chronic Kidney Disease

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byJeanie Park, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Emory University

Must not be taking: Bicarbonate, Central α-agonists, Immunosuppressives

Disqualifiers: Severe CKD, Heart failure, Anemia, others

No Placebo Group

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial aims to help people with chronic kidney disease improve their ability to exercise. It uses regular physical activity and a substance similar to baking soda to make it easier for their muscles to get enough blood during exercise.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as central α-agonists (like clonidine) and immunosuppressive medications (like steroids and biologics). If you are on these medications, you may need to discuss alternatives with your doctor.

What data supports the effectiveness of exercise as a treatment for chronic kidney disease?

Research shows that exercise can improve physical function, fitness, and quality of life in people with chronic kidney disease. It may also help with blood pressure control and mental health, although more studies are needed to confirm these benefits.¹ ² ³ ⁴ ⁵

Is exercise safe for people with chronic kidney disease?

Exercise is generally considered safe for people with chronic kidney disease, including those on dialysis, with no reports of serious injury. However, some common minor issues like low blood pressure and muscle cramps have been noted during exercise sessions.⁴ ⁶ ⁷ ⁸ ⁹

How is the exercise treatment for chronic kidney disease different from other treatments?

Exercise treatment for chronic kidney disease is unique because it focuses on improving physical function and quality of life through physical activity, rather than using medication. It aims to enhance cardiovascular health, muscle strength, and overall well-being, which are often neglected in standard care for CKD patients.³ ⁴ ⁹ ¹⁰ ¹¹

Research Team

Jeanie Park, MD

Principal Investigator

Emory University

Eligibility Criteria

This trial is for sedentary adults with stable chronic kidney disease (CKD) or healthy individuals as controls. CKD participants should have a steady kidney function, normal serum bicarbonate levels, and may have hypertension. Excluded are those with severe obesity, uncontrolled high blood pressure, recent surgery, pregnancy plans, certain heart conditions or metal implants that affect MRI scanning.

Inclusion Criteria

I either have chronic kidney disease or I do not have any kidney disease.

You don't regularly exercise, meaning you exercise for less than 20 minutes, twice a week.

My kidney function is stable and my blood's bicarbonate level is within the normal range.

See 1 more

Exclusion Criteria

You have a condition called metabolic alkalosis.

Your blood has low levels of hemoglobin, which is less than 10 grams per deciliter.

My BMI is over 40.

See 21 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline measurements in healthy participants without CKD will be measured and compared to participants with CKD

1 week

1 visit (in-person)

Treatment

Participants with CKD undergo exercise training for 20-45 minutes, 3 times per week, for 12 weeks, with either sodium bicarbonate or placebo

12 weeks

36 visits (in-person)

Follow-up

Participants are monitored for changes in exercise capacity, MSNA, IL-6, blood pressure, T2water, lean body mass, and exercise pressor reflex

4 weeks

Treatment Details

Interventions

Exercise Training (Behavioral Intervention)
Placebo (Other)
Sodium Bicarbonate (Other)

Trial OverviewThe study explores how exercise affects people with CKD compared to healthy controls. It tests whether exercise training or sodium bicarbonate supplementation can improve the body's response to physical activity in CKD patients versus a placebo group.

Participant Groups

3Treatment groups

Experimental Treatment

Active Control

Group I: Exercise Training plus Sodium BicarbonateExperimental Treatment2 Interventions

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.

Group II: Exercise Training plus PlaceboActive Control2 Interventions

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.

Group III: Healthy controlActive Control1 Intervention

Baseline measurements in healthy participants without CKD will be measured and compared to participants with CKD. Healthy controls will not receive any interventions.

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:

Emory ClinicAtlanta, GA

Atlanta VA Medical CenterDecatur, GA

Loading ...

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1735

Patients Recruited

2,605,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3987

Patients Recruited

47,860,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of an exercise rehabilitation program on physical function over 1 year in chronic kidney disease: an observational study.Hargrove, N., Tays, Q., Storsley, L., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advancing Exercise Science for Better Health Outcomes Across the Spectrum of Chronic Kidney Disease.Bohm, C., Bennett, P., Lambert, K., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise therapy in individuals with chronic kidney disease: a systematic review and synthesis of the research evidence.Koufaki, P., Greenwood, SA., Macdougall, IC., et al.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise and chronic kidney disease: current recommendations.Johansen, KL.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The physical deterioration of dialysis patients-Ignored, ill-reported, and ill-treated.Bennett, PN., Capdarest-Arest, N., Parker, K.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise in the end-stage renal disease population.Johansen, KL.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise training during hemodialysis in Brazil: A national survey.Barros, FS., Pinheiro, BV., Lucinda, LMF., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise training in patients after kidney transplantation.De Smet, S., Van Craenenbroeck, AH.[2021]

An exercise program combining supervised training and home-based training significantly improved physical fitness in patients with chronic kidney disease (CKD), as shown by increased metabolic equivalent tasks (METs) and 6-minute walk distance after 10 months.

The study found no serious adverse events related to the exercise training, indicating that this intervention is safe for patients with CKD, although the study was not specifically designed to assess safety outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise training in CKD: efficacy, adherence, and safety.Howden, EJ., Coombes, JS., Strand, H., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise as a therapeutic intervention in chronic kidney disease: are we nearly there yet?Castle, EM., Billany, RE., Lightfoot, CJ., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing exercise: what do we know? Where do we go?Painter, P.[2022]