Resistance Training for Chronic Kidney Disease

(EPIC Trial)

Overseen By Jenna Lauderback

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Dialysis, Walking device, Recent surgery, Diabetes, Others

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

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and feasibility of a 12-week high-velocity resistance training program (fast-paced weight exercises) for older adults with severe chronic kidney disease. The study compares this exercise program to regular health education sessions to determine which better improves muscle strength and physical abilities. Individuals with chronic kidney disease who can exercise and live near Wake Forest may be suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance exercise guidelines for those with chronic kidney disease.

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 is best to discuss this with the study team or your doctor.

What prior data suggests that this high-velocity resistance training is safe for older adults with chronic kidney disease?

Research has shown that high-speed strength training (HVRT) is generally safe for older adults, including those with chronic kidney disease (CKD). In studies involving middle-aged and older adults, HVRT reduced physical limitations without causing major side effects. Participants often experienced improvements in muscle strength and overall physical abilities.

Although these studies did not specifically target individuals with advanced CKD, the general findings suggest that HVRT is well-tolerated. Exercise, in general, benefits CKD by enhancing muscle strength and slowing disease progression. While more specific information on safety for advanced CKD patients is needed, current evidence supports the potential safety of HVRT for this group. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about high-velocity resistance training (HVRT) for chronic kidney disease because it offers a novel approach to improving patients' physical and cognitive health. Unlike standard treatments that focus primarily on medication and dietary adjustments, HVRT emphasizes rapid, controlled muscle movements using equipment like weighted vests and resistance bands. This method not only aims to enhance muscle strength and endurance but also targets improvements in overall body composition and cognitive function. By integrating exercise that combines speed with resistance, HVRT has the potential to significantly boost quality of life for individuals with chronic kidney disease in ways traditional treatments might not.

What evidence suggests that high-velocity resistance training is effective for chronic kidney disease?

Research has shown that high-speed resistance training (HVRT), which participants in this trial may receive, can help individuals with chronic kidney disease (CKD) improve their physical abilities. Studies indicate that exercises like HVRT can increase muscle strength, stamina, and balance, which are crucial for maintaining mobility with age. For those with CKD, exercise can also help slow disease progression and enhance overall quality of life. Specifically, individuals with CKD who have engaged in resistance training have demonstrated improvements in muscle function and physical performance. This suggests that HVRT might effectively support muscle strength and physical abilities in older adults with advanced CKD. ^{1 3 4 5 6}

Who Is on the Research Team?

Eliott Arroyo, PhD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for older adults with advanced chronic kidney disease (stages 4-5) who have limited mobility. Participants should be interested in improving their muscle power and physical function.

Inclusion Criteria

My kidney function is severely reduced.

My physical performance score is 9 or higher.

I am willing to be assigned to any treatment group by chance.

Exclusion Criteria

I am on dialysis or expected to start within 6 months.

I have not had joint surgery in the past 6 months and do not plan to in the next 6 months.

I rely on a device like a cane or walker to move around.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 12-week high-velocity resistance training (HVRT) intervention or attend weekly group sessions as part of the attention control group

12 weeks

3 visits per week (in-person) for HVRT group; 1 visit per week (in-person) for control group

Follow-up

Participants are monitored for changes in physical function, body composition, quality of life, and cognitive function outcomes

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• High-Velocity Resistance Training

Trial Overview The study tests a 12-week high-velocity resistance training program against weekly group sessions on healthy living. The goal is to see if the exercise program is doable, safe, and effective at boosting muscle strength and helping participants move better.

How Is the Trial Designed?

Group I: High-Velocity Resistance Training (HVRT) Experimental Treatment 1 Intervention

Those assigned to HVRT will attend three small-group (two to five people) exercise sessions lasting 60-75 minutes per week consisting of upper- and lower-body movements performed with weighted vests, medicine balls, and resistance bands. For all exercises, the concentric phase (muscle-shortening portion) will be performed as quickly as possible while maintaining good form, followed by a 1-second pause and then the eccentric phase (lengthening portion) completed in a slow and controlled fashion. Following completion of the 12-week intervention, all participants will be asked to complete the same baseline tests to assess changes in physical function, body composition, quality of life, and cognitive function outcomes.

Group II: Control Group Active Control 1 Intervention

Participants randomized to the attention control group will receive dedicated contact, information, and motivation throughout the course of the intervention via weekly group sessions and informational handouts. Each in-person group meeting will last approximately one hour. These group sessions will take place in a classroom/conference room setting and include information on such topics as blood pressure, reading food labels, healthy eating, and memory. The class will be a PowerPoint presentation with incorporated question/answer, lively discussion, and group-bonding activities. Following completion of the 12-week intervention, all participants will be asked to complete the same baseline tests to assess changes in physical function, body composition, quality of life, and cognitive function outcomes.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

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]

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]

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]

A 10-week supervised resistance exercise program significantly improved health-related quality of life and physical performance in 16 kidney transplant recipients, with notable enhancements in specific quality of life domains and physical tests like the 6-minute walk distance and handgrip strength.

The exercise intervention was safe, with no reported adverse events or injuries, indicating that resistance training can be a beneficial and safe rehabilitation strategy for kidney transplant patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a resistance training program in kidney transplant recipients: A randomized controlled trial. Hernández Sánchez, S., Carrero, JJ., Morales, JS., et al.[2021]

Resistance training (RT) has been shown to significantly improve muscle strength and quality of life in chronic kidney patients undergoing hemodialysis, based on a review of 21 studies.

All studies reviewed reported positive outcomes related to biochemical parameters, physical capacity, and body composition, highlighting the potential benefits of incorporating RT into the care of hemodialysis patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resistance training in hemodialysis patients: a review. Bessa, B., de Oliveira Leal, V., Moraes, C., et al.[2015]

Combined exercise training is the most effective modality for improving aerobic capacity and controlling arterial blood pressure in adults requiring haemodialysis for end-stage renal disease, based on a systematic review of 33 trials with 1254 participants.

Aerobic training specifically improved haemodialysis efficiency, but no exercise modality was superior to control for this outcome, highlighting the unique benefits of different training types for various health metrics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined training is the most effective training modality to improve aerobic capacity and blood pressure control in people requiring haemodialysis for end-stage renal disease: systematic review and network meta-analysis. Scapini, KB., Bohlke, M., Moraes, OA., et al.[2019]

In a study of 26 chronic kidney disease patients, blood flow restriction training led to significant increases in the diameter of the radial artery, indicating potential benefits for vascular health, but did not outperform conventional exercise without blood flow restriction.

Both blood flow restriction and control groups showed increases in cephalic vein diameter, suggesting that physical training is beneficial for vascular adaptations in patients with arteriovenous fistulas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does blood flow restriction training increase the diameter of forearm vessels in chronic kidney disease patients? A randomized clinical trial. Barbosa, JB., Maia, TO., Alves, PS., et al.[2019]

A 6-month home-based exercise program significantly improved physical functioning in patients with Stage 4 chronic kidney disease (CKD), as evidenced by a greater increase in the incremental shuttle walking test compared to a control group.

The exercise program also enhanced health-related quality of life (HRQOL) in several domains, including work status and social interaction, while showing potential benefits on kidney function and related biomarkers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based aerobic exercise and resistance training for severe chronic kidney disease: a randomized controlled trial. Uchiyama, K., Adachi, K., Muraoka, K., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06738394

Enhancing Physical Function in Older Adults With Chronic ... This study seeks to determine whether an HVRT intervention in mobility-limited older adults with advanced CKD is feasible, safe, and potentially effective for ...

2. 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 ...

3. 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.

4. ctv.veeva.com ctv.veeva.com/study/enhancing-physical-function-in-older-adults-with-chronic-kidney-disease

Enhancing Physical Function in Older Adults With Chronic ... The goal of this pilot randomized controlled trial is to examine the feasibility and safety of a 12-week high-velocity resistance training (HVRT) ...

5. frontiersin.org frontiersin.org/journals/physiology/articles/10.3389/fphys.2022.914508/full

Resistance Exercise in People With Stage-3 Chronic ... The aim of this study was to examine the effectiveness of RT as a preventive measure against the CKD-related muscle wasting in people with stage-3 CKD (CKD-3).

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8792527/

High-velocity resistance training mitigates physiological ... High-velocity resistance training mitigates physiological and functional impairments in middle-aged and older adults with and without mobility-limitation.