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

Trial Summary

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}

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.

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.

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

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
• 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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Effect of an exercise rehabilitation program on physical function over 1 year in chronic kidney disease: an observational study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Advancing Exercise Science for Better Health Outcomes Across the Spectrum of Chronic Kidney Disease. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Exercise therapy in individuals with chronic kidney disease: a systematic review and synthesis of the research evidence. [2018]

4. New Zealand pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

The physical deterioration of dialysis patients-Ignored, ill-reported, and ill-treated. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. United States pubmed.ncbi.nlm.nih.gov

Exercise training during hemodialysis in Brazil: A national survey. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Exercise training in patients after kidney transplantation. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Exercise training in CKD: efficacy, adherence, and safety. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Exercise as a therapeutic intervention in chronic kidney disease: are we nearly there yet? [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Implementing exercise: what do we know? Where do we go? [2022]