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

Trial Summary

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 data supports the effectiveness of the treatment Exercise, Physical Activity, Workout, Fitness Training for muscle atrophy in chronic kidney disease?

Research shows that exercise training can improve muscle strength and physical performance in chronic kidney disease patients, even though it may not significantly increase muscle mass. Exercise also helps improve physical activity levels, which is important because low activity is linked to higher mortality in these patients. ^{1 2 3 4 5}

Is exercise safe for people with chronic kidney disease?

Research suggests that modest exercise is generally safe for people with chronic kidney disease, and it may help improve muscle function and physical ability. However, the safety of long-term exercise training in this group is still uncertain, and more studies are needed to confirm its safety and benefits. ^{2 6 7 8 9}

How does exercise differ from other treatments for muscle atrophy in chronic kidney disease?

Exercise is unique because it directly improves muscle strength, endurance, and physical function, which can help prevent muscle loss in chronic kidney disease patients. Unlike medications, exercise is a non-invasive approach that can enhance overall quality of life and reduce mortality rates by addressing physical inactivity and muscle wasting. ^{1 3 9 10 11}

What is the purpose of this trial?

The aging Veteran population has more frequent inpatient hospitalization than non-Veterans. In addition, older Veterans have an inability to fully recover muscle mass and function after hospital-acquired weakness. The problem of hospital-acquired weakness is greatly increased in at-risk Veteran populations such as those with chronic kidney disease (CKD). The purpose of this collaborative study involving Denver and Baltimore VAMC sites is to improve health through the detection and rehabilitation management of hospital-acquired weakness in those with CKD. The study goals include identifying and monitoring the optimal muscle assessment sites in clinical settings, examining how muscle health impacts length of hospital stay and physical resilience, and determining how home-based and supervised exercise comparatively addresses post-hospitalization physical resilience using performance tests and Veteran feedback.

Research Team

Michael Harris-Love, DSc MPT BS

Principal Investigator

Rocky Mountain Regional VA Medical Center, Aurora, CO

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Resistance exercise and nutritional interventions for augmenting sarcopenia outcomes in chronic kidney disease: a narrative review. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Sarcopenia and Physical Inactivity in Patients With Chronic Kidney Disease. [2020]

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

Strategies to improve physical activity by exercise training in patients with chronic kidney disease. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

The Effect of Nutrition and Exercise on Body Composition, Exercise Capacity, and Physical Functioning in Advanced CKD Patients. [2022]

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

Correlates of Physical Functioning and Performance Across the Spectrum of Kidney Function. [2022]

6. Japan pubmed.ncbi.nlm.nih.gov

The effectiveness and safety of modest exercise in Japanese patients with chronic kidney disease: a single-armed interventional study. [2022]

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

Skeletal Muscle Complications in Chronic Kidney Disease. [2023]

8. United States 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. [2023]

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

Potential benefits of resistance exercise training on nutritional status in renal failure. [2019]

10. Sweden pubmed.ncbi.nlm.nih.gov

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

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

Effect of chair stand exercise on activity of daily living: a randomized controlled trial in hemodialysis patients. [2022]