Combination Exercise for Chronic Kidney Disease

Recruiting at 1 trial location

Overseen By Jared M Gollie, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Acute renal failure, Non-ambulatory, Uncontrolled cardiovascular, 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: Unknown

Duration: 12 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new exercise approach to assist veterans with chronic kidney disease before dialysis becomes necessary. It combines flywheel resistance and aerobic exercise to potentially enhance muscle function and overall health. Participants must have chronic kidney disease, specifically stages 3 or 4, and be able to walk, with or without assistance. The goal is to determine if this exercise can prevent future health issues related to kidney disease. As an unphased trial, this study allows participants to contribute to innovative research that could improve health outcomes for others with similar conditions.

Do I have to stop taking my current medications for the trial?

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 combination exercise is safe for individuals with chronic kidney disease?

Research shows that combining resistance and aerobic exercises is generally safe for people with chronic kidney disease. Studies have found that exercise not only improves the condition but is also well-tolerated by patients. Most participants report no serious side effects. Instead, exercise can slow the disease's progression and enhance overall quality of life. This suggests that combining these exercises is a safe option for managing chronic kidney disease. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combination exercise for chronic kidney disease because it merges flywheel resistance exercise with aerobic exercise, offering a novel approach compared to standard care, which typically focuses on medication and lifestyle adjustments. This unique blend of exercises aims to improve muscle strength and cardiovascular health simultaneously, which could lead to better overall health outcomes for patients. Unlike traditional treatments that might not address physical fitness directly, this exercise regimen could enhance quality of life and slow disease progression, making it a promising complementary strategy alongside existing therapies.

What evidence suggests that combination exercise is effective for chronic kidney disease?

This trial will compare the effects of a combination exercise regimen with standard-of-care activity levels for individuals with chronic kidney disease. Research has shown that combining aerobic and resistance exercises can significantly improve muscle strength, muscle size, and exercise ability in these individuals. Studies have found that exercise can positively affect chronic kidney disease by slowing its progression and improving quality of life. The strongest evidence supports aerobic exercise, which enhances physical fitness, muscle strength, and quality of life, especially for those on dialysis. Overall, combining exercises like flywheel resistance and aerobic activities is believed to help combat muscle issues and prevent physical decline in these patients. ^{1 2 3 4 6}

Who Is on the Research Team?

Jared M. Gollie, PhD

Principal Investigator

Washington DC VA Medical Center, Washington, DC

Are You a Good Fit for This Trial?

This trial is for English-speaking Veterans over 50 with chronic kidney disease stages 3 & 4 who can walk (with or without help). It's not for those with acute kidney issues in the past year, non-ambulatory individuals, people planning to move from the DC area within a year, or those with uncontrolled heart or musculoskeletal conditions.

Inclusion Criteria

All participants must be able to speak and read English, and demonstrate orientation to person, place, and time

I can walk and have no signs of kidney disease in the past year.

I am 50 or older, can walk (with or without help), and have stage 3 or 4 CKD not on dialysis.

Exclusion Criteria

I do not have any uncontrolled heart or muscle diseases that make it unsafe for me to join the study.

I was diagnosed with acute kidney failure in the last year.

Individuals with plans to relocate from the DC metro area within one year will not be eligible for the intervention portion of the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 12 weeks of flywheel resistance plus aerobic exercise training to improve fatigability status, neuromuscular capacity, and physical function

12 weeks

Follow-up

Participants are monitored for changes in fatigability, neuromuscular capacity, and physical function

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Combination Exercise

Trial Overview The study tests combination exercise (flywheel resistance plus aerobic) on fatigue in Veterans with chronic kidney disease. The goal is to see if this exercise can improve muscle function and overall health compared to a control group without kidney disease.

How Is the Trial Designed?

Group I: Combination Exercise Experimental Treatment 1 Intervention

Flywheel resistance exercise plus aerobic exercise

Group II: Standard-of-care Active Control 1 Intervention

Participants will maintain standard-of-care and current activity levels during the course of the study.

Combination Exercise is already approved in United States for the following indications:

Approved in United States as Combination Exercise Therapy for:

• Neuromuscular dysfunction in chronic kidney disease
• Functional decline in chronic kidney disease

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

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]

Combined aerobic and resistance exercise (CARE) significantly improves renal function in adults with chronic kidney disease (CKD), as evidenced by increased estimated glomerular filtration rate and decreased serum creatinine levels in a meta-analysis of 12 studies involving 745 patients.

CARE also leads to reductions in blood pressure, indicating additional cardiovascular benefits, although it does not significantly affect proteinuria, lipid levels, physical composition, or quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of combined aerobic and resistance exercise on renal function in adult patients with chronic kidney disease: a systematic review and meta-analysis. Wu, X., Yang, L., Wang, Y., et al.[2022]

Long-term aerobic training (at least 30 months) is safe for hemodialysis patients and helps maintain their functional capacity, as shown by significant improvements in the six-minute walking test distance.

Discontinuing the exercise program (detraining) for at least 10 months leads to a significant decrease in functional capacity, highlighting the importance of consistent exercise for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of long-term aerobic training and detraining on functional capacity and quality of life in hemodialysis patients: A pilot study. Gravina, EPL., Pinheiro, BV., da Silva Jesus, LA., et al.[2020]

Chronic kidney disease (CKD) patients face a higher risk of cardiovascular disease (CVD) and related complications, making it crucial to address their physical activity levels.

Incorporating aerobic and resistance exercise into the care of CKD patients can improve their aerobic capacity, strength, and overall cardiovascular health, which is essential given the limited treatment options available for managing CVD risk in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity and Exercise for Cardiorespiratory Health and Fitness in Chronic Kidney Disease. Gollie, JM., Cohen, SD., Patel, SS.[2023]

In a study involving 41 nondialysis patients with chronic kidney disease (CKD) stages 3b-5, combined aerobic and resistance exercise (CE) resulted in a 48% increase in knee extensor strength, significantly greater than the 16% increase from aerobic exercise alone (AE).

CE also led to a 9% increase in quadriceps muscle volume compared to a 5% increase from AE, demonstrating that adding resistance training to aerobic workouts provides superior benefits in muscle strength and mass for CKD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Twelve-week combined resistance and aerobic training confers greater benefits than aerobic training alone in nondialysis CKD. Watson, EL., Gould, DW., Wilkinson, TJ., et al.[2022]

A preliminary study involving 4 men with chronic kidney disease (CKD) showed that a novel progressive eccentric-overload resistance exercise (ERE) program led to improvements in physical function and torque capacity after 24 training sessions, without any significant worsening of health status.

The results suggest that ERE may enhance fatigue resistance while increasing strength, indicating its potential as a beneficial treatment for maintaining physical function in CKD patients, although further research is needed to optimize the exercise regimen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary Study of the Effects of Eccentric-Overload Resistance Exercise on Physical Function and Torque Capacity in Chronic Kidney Disease. Gollie, JM., Patel, SS., Scholten, JD., et al.[2023]

In a randomized controlled trial involving 26 haemodialysis patients over 10 weeks, combining resistance and aerobic exercise significantly improved functional performance, as measured by the 6-minute walk test, with an average increase of 39.7 meters compared to a decrease of 19.2 meters in the resistance-only group.

The results suggest that for haemodialysis patients, a combined exercise program is more effective than resistance training alone in enhancing physical function, although the optimal exercise protocol for this population remains to be determined.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined resistance and aerobic exercise is better than resistance training alone to improve functional performance of haemodialysis patients--results of a randomized controlled trial. Orcy, RB., Dias, PS., Seus, TL., et al.[2022]

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]

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]

Completing a renal rehabilitation (RR) program is associated with a significantly lower risk of serious health events, such as death or hospitalization, in patients with chronic kidney disease (CKD), as shown in a study of 757 patients over a median follow-up of 34 months.

Patients who improved their exercise capacity by at least 50 meters in the incremental shuttle walk test (ISWT) during RR had a 40% lower risk of combined health events, highlighting the importance of exercise improvement in reducing morbidity and mortality in CKD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mortality and morbidity following exercise-based renal rehabilitation in patients with chronic kidney disease: the effect of programme completion and change in exercise capacity. Greenwood, SA., Castle, E., Lindup, H., et al.[2021]

Citations

1. withpower.com withpower.com/trial/phase-3-renal-insufficiency-chronic-9-2021-a5c59

Combination Exercise for Chronic Kidney Disease Research shows that combining aerobic and resistance exercises can significantly improve muscle strength, muscle volume, and exercise capacity in patients with ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7717791/

Aerobic, resistance and combined training for adults with ... Studies have found that exercise training has a positive effect on improving the condition of chronic kidney disease. We will conduct a network ...

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4655802/

Effects of exercise in the whole spectrum of chronic kidney ... The strongest evidence is for the effects of aerobic exercise on improving physical fitness, muscular strength and quality of life in dialysis patients.

5. journals.lww.com journals.lww.com/md-journal/fulltext/2020/12040/aerobic,_resistance_and_combined_training_for.101.aspx

Aerobic, resistance and combined training for adults with... Studies have found that exercise training has a positive effect on improving the condition of chronic kidney disease. We will conduct a network ...

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

Clinical practice guideline exercise and lifestyle in chronic ... Long-term pulse wave velocity outcomes with aerobic and resistance training in kidney transplant recipients–a pilot randomised controlled trial.