Exercise for Kidney Failure

Overseen By Deborah Zimmerman, MD, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Hospital Research Institute

Disqualifiers: Unstable angina, Uncontrolled hypertension, 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 months

90 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will be conducted over a 3 year time period. This is a trial of an exercise intervention vs. standard of care in patients receiving chronic dialysis. The specific aims will be to determine feasibility of patient recruitment, adherence to the exercise program, and efficacy of the intervention on patient important outcomes. The exercise intervention will be delivered to randomized participants for 12 months, and consist of the prescribed use of Nordic Walking poles, online resources for exercise in the home, regular use of a pedometer to monitor progress, and regular verbal encouragement to exercise (monthly) by dialysis unit staff. Both groups will receive the same standard of care co-interventions including individualized dialysis prescriptions and health-care interactions according to practices at their centre.

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 focuses on exercise for patients on dialysis, so it's best to discuss your medications with the trial team or your doctor.

What data supports the effectiveness of the treatment Exercise Prescription, Physical Activity, Exercise Therapy, Exercise Intervention for kidney failure?

Research shows that exercise programs, like a simple walking routine, can improve the health and reduce hospital visits for people with kidney failure. Physical activity is also linked to better quality of life and outcomes for those with chronic kidney disease. ^{1 2 3 4 5}

Is exercise safe for people with kidney conditions?

Exercise interventions, including resistance training and physical activity, have been shown to be safe for people with kidney conditions, such as those on dialysis or who have had a kidney transplant. Studies report no adverse events like injuries or hospitalizations related to exercise, and they often improve quality of life and physical performance. ^{1 6 7 8 9}

How is the exercise treatment for kidney failure different from other treatments?

Exercise treatment for kidney failure is unique because it focuses on improving physical functioning and quality of life through physical activity, rather than using medications or surgical interventions. It helps reduce cardiovascular risk, inflammation, and hypertension (high blood pressure), and increases strength and exercise capacity, which are not typically addressed by standard medical treatments for kidney failure. ^{1 10 11 12 13}

Research Team

Deborah Zimmerman, MD, MSc

Principal Investigator

Ottawa Hospital Research Institute

Eligibility Criteria

This trial is for adults with end stage kidney disease who have been on dialysis for over six months, can walk, understand English or French, and are willing to use Nordic Walking poles. It's not suitable for those with conditions like unstable angina or uncontrolled high blood pressure, a daily step count over 8000 steps, an upcoming kidney transplant from a living donor, potential renal recovery, reliance on other mobility aids they feel unsafe replacing with walking poles, or participation in another conflicting trial.

Inclusion Criteria

I can understand English or French.

Abuse to use Nordic Walking poles

I have severe kidney disease and can walk.

Exclusion Criteria

I am scheduled for a kidney transplant from a living donor.

I feel unsafe using Nordic walking poles instead of my usual mobility aid.

My kidney function is expected to improve.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the exercise intervention for 12 months, including Nordic Walking poles, online resources, pedometer use, and monthly encouragement

12 months

Monthly visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

• Exercise Prescription

Trial Overview The study tests if exercise helps people receiving chronic dialysis. Participants will be randomly assigned to either receive standard care or add an exercise program using Nordic Walking poles and online resources for one year. Their progress will be tracked with pedometers and encouraged by staff monthly.

Participant Groups

Group I: Exercise Intervention Experimental Treatment 1 Intervention

Participants in this arm will receive standard of care along with the exercise prescription intervention

Group II: Standard of Care Active Control 1 Intervention

This group will receive standard of care treatment including regular verbal encouragement to exercise (monthly) by dialysis unit staff.

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Findings from Research

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 6-month personalized walking exercise program for patients with kidney failure significantly reduced the long-term risk of hospitalization or death by 29% during a follow-up of up to 36 months, based on data from 227 participants.

Patients who adhered to the exercise program (attending more than 60% of sessions) experienced an even greater benefit, with a 45% lower risk of hospitalization or death compared to the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Effect of Physical Exercise on the Risk for Hospitalization and Death in Dialysis Patients: A Post-Trial Long-Term Observational Study. Mallamaci, F., D'Arrigo, G., Tripepi, G., et al.[2023]

In a study of 130 patients with chronic kidney disease, those on renal substitution therapy for less than 6 months engaged in more physical activity compared to those diagnosed longer, suggesting early intervention may encourage activity levels.

Higher levels of moderate and vigorous physical activity were linked to better physical functioning and general health perceptions, particularly in women and patients diagnosed between 7 to 18 months, indicating that physical activity can enhance quality of life in chronic kidney disease patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Association of physical activity with quality of life in patients with chronic kidney disease]. Pinillos-Patiño, Y., Herazo-Beltrán, Y., Gil Cataño, J., et al.[2021]

Exercise interventions, particularly moderate-intensity activities like walking, are effective in improving fitness and health outcomes for patients with chronic kidney disease (CKD), as recommended by updated KDIGO guidelines.

Incorporating exercise into CKD care can reduce mortality and morbidity associated with a sedentary lifestyle, and even more vigorous exercise can be safely prescribed to patients with various comorbidities for greater health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of exercise training in the management of chronic kidney disease. Howden, EJ., Coombes, JS., Isbel, NM.[2015]

A study of 133 kidney transplant recipients revealed that they spent an average of 9.4 hours per day being sedentary and only engaged in about 20.7 minutes of moderate-to-vigorous physical activity, indicating a need for increased physical activity among this population.

Factors such as age, body mass index, education, and income were found to influence levels of physical activity and sedentary time, suggesting that targeted interventions could help improve activity levels and reduce sedentary behavior in kidney transplant recipients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence and Correlates of Accelerometer-Based Physical Activity and Sedentary Time Among Kidney Transplant Recipients. Vallance, JK., Johnson, ST., Thompson, S., et al.[2022]

Kidney transplant recipients generally engage in lower levels of physical activity compared to the general population, which can lead to reduced quality of life and increased mortality risk.

Exercise training interventions are safe for kidney transplant recipients and have been shown to improve both quality of life and exercise capacity, indicating a potential benefit that warrants further research into long-term cardiovascular outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity in Kidney Transplant Recipients: A Review. Takahashi, A., Hu, SL., Bostom, A.[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]

This nonrandomized trial aims to improve the physical function and quality of life in patients with end-stage kidney disease (ESKD) through various low-intensity exercise programs, highlighting the importance of patient choice in their exercise regimen.

The study will assess the feasibility, safety, and adherence to these exercise interventions over three months, with outcomes including aerobic capacity, quality of life, and long-term clinical results, providing valuable insights into effective strategies for increasing physical activity in ESKD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Personalized Patient-Centered Intervention to Empower through Physical Activity the Patient in the Dialysis Center: Study Protocol for a Pragmatic Nonrandomized Clinical Trial. Manfredini, F., Lamberti, N., Battaglia, Y., et al.[2021]

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]

Exercise is increasingly recognized as an effective treatment and preventive measure for various medical conditions, including chronic kidney disease, which affects about 10% of the population.

The review highlights that exercise can improve cardiovascular health, reduce inflammation, and enhance physical functioning in kidney disease patients, suggesting it should be integrated into clinical management strategies for all stages of the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Exercise as medicine" in chronic kidney disease. Wilkinson, TJ., Shur, NF., Smith, AC.[2022]

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]

Patients with kidney failure undergoing dialysis have significantly low exercise capacity, which affects their ability to perform daily activities and work, but this can be improved through interventions like kidney transplants and exercise training.

Epoetin therapy can help correct anemia in these patients, leading to increased exercise tolerance; however, the improvement in exercise capacity is modest compared to the increase in hematocrit levels, suggesting that additional exercise training and motivation are essential for maximizing physical function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The importance of exercise training in rehabilitation of patients with end-stage renal disease. Painter, P.[2005]

Patients with chronic kidney disease (CKD) and those on dialysis are often sedentary, with many not engaging in any physical activity, which is linked to higher risks of health complications and mortality.

The review highlights the importance of physical exercise in improving clinical outcomes for CKD and dialysis patients, emphasizing the need for specific exercise recommendations to combat the negative effects of a sedentary lifestyle.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity in chronic kidney disease and the EXerCise Introduction To Enhance trial. Mallamaci, F., Pisano, A., Tripepi, G.[2020]

References

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

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

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

Long-Term Effect of Physical Exercise on the Risk for Hospitalization and Death in Dialysis Patients: A Post-Trial Long-Term Observational Study. [2023]

3. Chile pubmed.ncbi.nlm.nih.gov

[Association of physical activity with quality of life in patients with chronic kidney disease]. [2021]

4. England pubmed.ncbi.nlm.nih.gov

The role of exercise training in the management of chronic kidney disease. [2015]

5. England pubmed.ncbi.nlm.nih.gov

Prevalence and Correlates of Accelerometer-Based Physical Activity and Sedentary Time Among Kidney Transplant Recipients. [2022]

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

Physical Activity in Kidney Transplant Recipients: A Review. [2019]

7. 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]

8. Switzerland pubmed.ncbi.nlm.nih.gov

A Personalized Patient-Centered Intervention to Empower through Physical Activity the Patient in the Dialysis Center: Study Protocol for a Pragmatic Nonrandomized Clinical Trial. [2021]

9. Denmark pubmed.ncbi.nlm.nih.gov

Effects of a resistance training program in kidney transplant recipients: A randomized controlled trial. [2021]

10. Denmark pubmed.ncbi.nlm.nih.gov

"Exercise as medicine" in chronic kidney disease. [2022]

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

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

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

The importance of exercise training in rehabilitation of patients with end-stage renal disease. [2005]

13. England pubmed.ncbi.nlm.nih.gov

Physical activity in chronic kidney disease and the EXerCise Introduction To Enhance trial. [2020]