Exercise for Chronic Kidney Disease

Recruiting at 1 trial location

Overseen By Jeanie Park, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Emory University

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

Disqualifiers: Severe CKD, Heart failure, Anemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 37

Duration: 12 weeks

156 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how exercise can help people with chronic kidney disease (CKD) improve their exercise capacity. Participants will engage in exercise training (also known as cardiac rehabilitation or physical therapy) while taking either sodium bicarbonate or a placebo. A group of healthy individuals will serve as a comparison. The trial aims to understand how exercise affects those with CKD and whether sodium bicarbonate provides additional benefits. This trial may suit people with CKD who don't exercise often and have stable kidney function. As a Phase 2 trial, it measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important research.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that exercise is generally safe for people with chronic kidney disease (CKD). In one study, participants handled exercise well, with no exercise-related problems. Another study found that a year-long exercise program improved physical abilities without major safety concerns.

Regarding sodium bicarbonate treatment, studies suggest it can help manage CKD symptoms. It may slow the decline in kidney function and improve blood vessel health. However, it can raise bicarbonate levels in the blood, so monitoring is necessary.

Overall, previous studies have found both exercise and sodium bicarbonate to be safe for people with CKD. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for chronic kidney disease, which often involve medications to manage symptoms and slow disease progression, this approach combines exercise training with either sodium bicarbonate or a placebo. Researchers are excited because exercise training could improve physical fitness and overall health, potentially enhancing kidney function and quality of life. The addition of sodium bicarbonate is particularly intriguing as it might help reduce acidity in the body, a common issue in CKD, offering an extra boost to kidney health. This combination could present a more holistic approach, addressing both physical activity and metabolic balance, which is different from the typical pharmacological treatments.

What evidence suggests that this trial's treatments could be effective for chronic kidney disease?

Research has shown that regular exercise can greatly improve health for people with chronic kidney disease (CKD). It can enhance exercise capacity and may slow disease progression. Exercise might also address other health issues and improve overall quality of life.

In this trial, one group of participants will receive Exercise Training plus Sodium Bicarbonate, which helps manage metabolic acidosis—a condition where the body has too much acid, common in CKD patients. Sodium Bicarbonate can alleviate symptoms like high potassium levels, though its overall impact on kidney function remains mixed. The benefits for physical activity are also unclear. Another group will receive Exercise Training plus Placebo. Combining exercise and sodium bicarbonate might offer various health benefits for people with CKD. ^{3 5 6 7 8}

Who Is on the Research Team?

Jeanie Park, MD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Exercise Training
• Placebo
• Sodium Bicarbonate

Trial Overview The 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.

How Is the Trial Designed?

Group I: Exercise Training plus Sodium Bicarbonate Experimental Treatment 2 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 Placebo Active Control 2 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 control Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

Aerobic exercise interventions have been shown to improve physical functioning and performance in patients with chronic kidney disease (CKD), with evidence suggesting benefits for blood pressure control, lipid profiles, and mental health.

Despite the known safety and benefits of exercise for CKD patients, many remain inactive, highlighting the need for better assessment and encouragement of physical activity, particularly through low-intensity resistance and aerobic training programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Kidney transplantation is the preferred treatment for end-stage renal disease, but patients face increased risks of cancer, infections, and cardiovascular issues post-surgery.

Exercise training is highlighted as a crucial intervention to improve clinical outcomes after kidney transplantation, addressing the common problems of physical inactivity and poor fitness among recipients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Exercise training has been shown to significantly improve physical function, fitness, and quality of life in individuals with chronic kidney disease, yet it is not commonly included in standard kidney care programs.

To integrate exercise rehabilitation into kidney care, it is essential to focus on clinically relevant outcomes for patients, implement evidence-based strategies, and treat exercise as a legitimate medical therapy.

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]

Chronic kidney disease (CKD) significantly increases the risk of cardiovascular disease (CVD), which is a leading cause of health issues and death in CKD patients, highlighting the need for effective management strategies.

Research is focusing on exercise rehabilitation as a potential intervention to improve physical function, reduce CVD risk, and enhance quality of life for individuals with CKD, aiming to understand the mechanisms behind these benefits.

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]

Patients with chronic kidney disease (CKD) who are on dialysis typically have low exercise capacity and physical functioning, but regular exercise training can significantly improve these aspects.

Despite the clear benefits of exercise for CKD patients, the nephrology community has not yet integrated exercise recommendations into standard care practices, highlighting a need for better implementation of exercise counseling in treatment plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

Recent evidence supports the use of exercise-based rehabilitation for individuals with chronic kidney disease (CKD), highlighting its potential to improve health-related quality of life and overall outcomes.

There is a growing commitment within the kidney research community to implement practical exercise interventions, including options for prehabilitation and post-transplant rehabilitation, as well as tailored programs for those undergoing hemodialysis.

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]

Exercise interventions, including aerobic and resistance training, have shown beneficial effects on physical functioning in patients with end-stage renal disease (ESRD) undergoing dialysis, highlighting the importance of exercise in this population.

Exercise during hemodialysis sessions has been found to be safe, with no reports of serious injuries, suggesting that incorporating exercise into routine care for dialysis patients is feasible and beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

A 10-week exercise rehabilitation program for individuals with chronic kidney disease (CKD) did not show a significant difference in physical function improvement after one year compared to nonattenders and a control group, indicating the need for further research on long-term effectiveness.

However, participants who attended the program were more likely to maintain regular exercise habits after one year, suggesting potential benefits in promoting sustained physical activity among CKD patients.

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]

Only 15.7% of the 261 surveyed dialysis units in Brazil offered exercise training during hemodialysis, with resistance training being the most common component (92.7%).

The main barriers to implementing and maintaining exercise programs were identified as a lack of resources and poor patient adherence, with hypotension and muscle cramps being the most frequently reported adverse events.

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]

Exercise can significantly improve physical function and quality of life for dialysis patients, but uptake of exercise among these patients is low due to a lack of exercise professionals in renal programs.

Only 0.4% of published research in physical therapy over the past decade has focused on kidney disease, indicating a significant gap in emphasis on renal rehabilitation, which may contribute to poorer outcomes for these patients.

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8207316/

Effectiveness and Utilization of Cardiac Rehabilitation Among ... For CR completers, median baseline exercise capacity was 6.4 (IQR 5.0–7.7) peak METs for those with CKD and 7.7 (6.4–9.0) METs for those without (P < 0.001).

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/24913219/

Exercise training in adults with CKD: a systematic review ... Conclusions: Regular exercise training generally is associated with improved health outcomes in individuals with CKD. Correctly designed exercise rehabilitation ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2772487525000248

Cardiovascular disease risk assessment, exercise training ... We propose a critical and comprehensive review to suggest how to manage patients with chronic kidney disease in clinical practice.

4. kireports.org kireports.org/article/S2468-0249(24)01862-X/fulltext

Review of Exercise Interventions to Improve Clinical ... The potential benefits of exercise training in CKD range from slowing disease progression to improving comorbidities and quality of life.

5. academic.oup.com academic.oup.com/eurjpc/article/31/12/1493/7642937

role of exercise training on cardiovascular risk factors and ... The RENEXC trial showed that a combined strength and aerobic training programme significantly reduced albuminuria in patients with CKD G3–G5.21. Effects of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4255415/

Effects of a Renal Rehabilitation Exercise Program in ... Overall, exercise training in this particular study setting and patient population was well tolerated, with no exercise-related adverse events observed. Larger ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35944747/

Effect of Long-term Exercise Training on Physical ... - PubMed A 12-month program of in-center aerobic and resistance exercise training was safe and associated with improvements in physical functioning.

8. bmcnephrol.biomedcentral.com bmcnephrol.biomedcentral.com/articles/10.1186/s12882-021-02618-1

Clinical practice guideline exercise and lifestyle in chronic ... This is the first document of its kind to set out the evidence for those people living with kidney disease, including those on haemodialysis and with a kidney ...