Exercise for Muscle Atrophy in Chronic Kidney Disease

(EMPHASIS Trial)

Recruiting at 1 trial location

Overseen By Katie Boncella, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Hypertension, Coronary event, CHF, others

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

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

Compensation: Varies

Number of Visits: 3

Duration: 16 weeks

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how exercise can aid people with chronic kidney disease (CKD) in regaining muscle strength after hospitalization. The goal is to determine if exercise, performed at home or with supervision, improves physical strength and reduces hospital stays. Participants will either perform specific exercises, such as squats and shoulder presses, twice a week for 16 weeks or continue with their usual care without added exercise. The trial seeks individuals over 55 with stage 3-4 CKD. As an unphased trial, it offers a unique opportunity to contribute to understanding the benefits of exercise for CKD patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this exercise protocol is safe for individuals with chronic kidney disease?

Studies have shown that exercise is generally safe for people with chronic kidney disease (CKD). Research indicates that exercise can improve physical abilities, such as muscle strength and balance, for people of all ages. Evidence also suggests that exercise can help slow the progression of CKD and enhance overall quality of life.

Importantly, a study reviewing multiple research findings found no significant increase in negative side effects, indicating these are uncommon. This suggests that exercise is well-tolerated by those with CKD. Therefore, for those considering joining a trial involving exercise, existing research supports its safety and potential benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using exercise for muscle atrophy in chronic kidney disease because it offers a non-pharmaceutical approach to managing a common complication of the condition. Unlike standard treatments that might involve medication to address symptoms or complications, this exercise regimen focuses on improving muscle strength and mass through specific movements like squats and shoulder presses. By concentrating on internal load and contraction velocity, this method could potentially enhance muscle function more naturally and with fewer side effects. This approach provides a promising alternative that empowers patients to play an active role in their health management.

What evidence suggests that exercise is effective for muscle atrophy in chronic kidney disease?

This trial will compare exercise with usual care for individuals with chronic kidney disease (CKD). Studies have shown that exercise can be very beneficial for people with CKD. Specifically, exercise improves physical abilities, such as muscle strength and balance, across all ages. Research also indicates that exercise reduces muscle loss and related issues in CKD. In studies with mice, resistance exercise increased muscle building and decreased muscle breakdown. Exercise can also slow disease progression and enhance the quality of life for those with CKD. Overall, strong evidence supports the benefits of exercise for muscle health in chronic kidney disease. ^{1 2 3 6 7}

Who Is on the Research Team?

Michael Harris-Love, DSc MPT BS

Principal Investigator

Rocky Mountain Regional VA Medical Center, Aurora, CO

Are You a Good Fit for This Trial?

This trial is for aging Veterans with chronic kidney disease who often experience muscle weakness after hospital stays. Participants should have a history of muscle mass and function loss post-hospitalization. The study excludes those not meeting specific health criteria, which are not detailed here.

Inclusion Criteria

I am older than 55 years.

My kidney function is reduced with a diagnosis of stage 3-4 CKD or my eGFR is below 45.

Exclusion Criteria

I need home oxygen for my COPD.

I have a history of severe heart failure.

My blood pressure is not higher than 160/100.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline cohort of Veterans with Stage 3 and 4 CKD is established and muscle health is assessed

4 weeks

1 visit (in-person)

Treatment

Participants undergo a supervised flywheel strengthening exercise program or receive usual care for 16 weeks

16 weeks

2 visits per week (in-person) for exercise group

Monitoring

Regular assessments of muscle health every six months and quarterly updates on strength and functional status via smartphone

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Exercise

Trial Overview The study aims to improve the recovery of muscle strength in older Veterans by monitoring muscle health and comparing home-based versus supervised exercise programs after they leave the hospital.

How Is the Trial Designed?

Group I: Exercise Experimental Treatment 1 Intervention

The participants will exercise 2 days a week for 16 weeks. The exercises will include 4 movements: squats, shoulder press, seated row, and bicep curl focusing on internal load and contraction velocity.

Group II: Usual Care Active Control 1 Intervention

Participants will not have any study intervention visits for usual care.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

Resistance or strength exercise training can significantly improve muscle mass, strength, and function in patients with chronic renal failure, potentially reversing malnutrition and delaying disease progression.

Even with low dietary protein intake, resistance training enhances protein metabolism and overall physical function, suggesting it could be a valuable, noninvasive treatment option for improving the quality of life in renal patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential benefits of resistance exercise training on nutritional status in renal failure. Castaneda, C., Grossi, L., Dwyer, J.[2019]

Exercise training significantly improves maximal exercise capacity, muscle strength, and endurance in patients with chronic kidney disease (CKD) across all stages, including those on dialysis and post-transplant.

Starting exercise training during the predialysis stage is ideal, as it helps combat muscle catabolism, weight loss, and enhances overall quality of life, making it a crucial part of CKD patient care prescribed by nephrologists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Physical working capacity and muscle strength in chronic renal failure are improved by exercise]. Clyne, N.[2006]

A 12-month supervised exercise program for older adults with advanced chronic kidney disease (CKD) was found to be safe and well-tolerated, with no significant increase in adverse events reported.

Participants in the exercise group showed significant improvements in physical functioning, including a greater distance walked in the 6-minute walk test and better performance on the Timed Up and Go Test, indicating that exercise can enhance physical capabilities in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Long-term Exercise Training on Physical Performance and Cardiorespiratory Function in Adults With CKD: A Randomized Controlled Trial. Weiner, DE., Liu, CK., Miao, S., et al.[2023]

A 6-month exercise program for 47 patients with chronic kidney disease (CKD) significantly improved physical performance, as shown by increased daily steps and better scores in various physical tests, without harming kidney function.

The program led to reductions in body weight, waist circumference, and blood pressure, while also decreasing proteinuria in some patients, suggesting that exercise is beneficial for CKD patients to prevent muscle wasting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness and safety of modest exercise in Japanese patients with chronic kidney disease: a single-armed interventional study. Hamada, M., Yasuda, Y., Kato, S., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8101627/

Exercise training in chronic kidney disease—effects ... There is convincing evidence that exercise training improves physical function measured as aerobic capacity, muscle endurance strength and balance at all ages ...

2. rrtjournal.biomedcentral.com rrtjournal.biomedcentral.com/articles/10.1186/s41100-025-00658-z

Effectiveness of exercise therapy in managing muscle atrophy ... Exercise therapy has been identified as a very effective technique for reducing muscle atrophy and related complications in chronic kidney ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0002916523017896

Review of muscle wasting associated with chronic kidney ... Wang et al (29) reported that resistance exercise in CKD mice exhibited an increase in protein synthesis and a reduction in protein degradation.

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. nature.com nature.com/articles/s41598-020-75405-x

Effects of exercise on kidney and physical function in ... This meta-analysis aimed to determine the effects of physical exercise training on the risk of mortality, kidney and physical functions, and adverse events

6. bmcsportsscimedrehabil.biomedcentral.com bmcsportsscimedrehabil.biomedcentral.com/articles/10.1186/s13102-024-00876-8

Application of exercise therapy in patients with chronic kidney ... The results of this study show that exercise intervention can improve physical function, activity ability, muscle atrophy, and quality of life ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S246802492401862X

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.