Exercise During Dialysis for Hemodialysis Patients

Not currently recruiting at 7 trial locations

Overseen By Ashley Seitz, BSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Manitoba

Disqualifiers: Acute coronary syndrome, Unstable arrhythmia, NYHA Class 4, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether exercising during dialysis can reduce heart stress in individuals receiving hemodialysis. Participants will either join a 12-week supervised cycling program during their dialysis sessions (known as Intradialytic Cycling) or continue with their usual care without formal exercise. The trial aims to determine if this exercise benefits the heart health of dialysis patients. It suits adults on hemodialysis for more than three months who can safely exercise and are not planning major changes like surgery or moving. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance heart health for dialysis patients.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that intradialytic cycling is safe for hemodialysis patients?

Research shows that exercising during dialysis, known as intradialytic cycling, is generally safe for individuals receiving hemodialysis. Studies have found that this exercise can aid in faster recovery after a dialysis session and improve overall well-being and physical fitness. No major safety issues have been reported. Many participants feel better and experience less depression, making it a safe option for those undergoing dialysis. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of intradialytic cycling for hemodialysis patients because it offers a unique way to integrate physical activity directly into dialysis sessions. Unlike traditional exercise recommendations that occur outside of treatment times, this method allows patients to exercise while undergoing dialysis, potentially improving their cardiovascular health and overall well-being without requiring extra time commitment. This approach could lead to better management of symptoms and enhanced quality of life, making it a promising addition to the usual care for those undergoing hemodialysis.

What evidence suggests that intradialytic cycling is effective for hemodialysis-induced myocardial stunning?

Research has shown that exercising during dialysis, known as intradialytic cycling, can benefit individuals with kidney problems. One study found that this exercise reduced the recovery time after dialysis sessions. Another study demonstrated that exercising during dialysis for a year increased patients' strength and stamina compared to those who did not exercise. Evidence also suggests that regular exercise during dialysis might help extend life expectancy. While scientists continue to explore the exact mechanisms, these benefits make intradialytic cycling a promising approach to improving the health of dialysis patients. Participants in this trial will either engage in a supervised intradialytic cycling program or receive usual care without formal exercise intervention during dialysis. ^{1 2 3 6 7}

Who Is on the Research Team?

Clara Bohm, MD, MPH

Principal Investigator

University of Manitoba

Are You a Good Fit for This Trial?

This trial is for adults over 18 who've been on hemodialysis for at least 3 months, with no major changes in their treatment expected. They must be cleared to exercise by a kidney doctor and able to communicate in English. People with recent heart issues, unstable heart rhythms, severe breathlessness, frequent low blood sugar episodes or those already doing similar cycling exercises can't join.

Inclusion Criteria

I don't plan any major changes like surgery or moving for the next 16 weeks.

I am 18 or older and have been on maintenance hemodialysis for over 3 months.

Assessed to be safe and able to exercise by the hemodialysis unit nephrologist

Exclusion Criteria

I have had low blood sugar symptoms more than twice a week recently.

I had a heart attack or other heart issue in the last 3 months.

I do not have an irregular heartbeat that changes often.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Exercise Counseling

Participants receive a standardized baseline exercise counseling session

1 week

Treatment

Participants engage in a supervised intradialytic cycling program for 12 weeks

12 weeks

During each hemodialysis session

Follow-up

Participants are monitored for changes in cardiac stunning and other health metrics

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Intradialytic Cycling

Trial Overview The study tests if cycling during dialysis sessions over 12 weeks affects the temporary weakening of the heart muscle that sometimes happens after hemodialysis (myocardial stunning). Participants will cycle while undergoing their regular dialysis treatments.

How Is the Trial Designed?

Group I: Exercise (Intradialytic Cycling) Experimental Treatment 1 Intervention

Participants will receive a standardized baseline exercise counseling session as per control and then participate in a supervised intradialytic cycling program for 12-weeks

Group II: Usual Care Active Control 1 Intervention

Participants will receive a standardized baseline exercise counseling session. Participants in the control group will not undergo formal exercise intervention, but will not be prohibited from participating in exercise outside of hemodialysis. They will be asked to not to participate in intradialytic cycling during the study (16 weeks total).

Intradialytic Cycling is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Intradialytic Cycling for:

• Improvement of physical function in hemodialysis patients
• Enhancement of cardiovascular health in patients undergoing hemodialysis

Approved in United States as Intradialytic Cycling for:

• Reduction of hemodialysis-induced myocardial stunning
• Improvement of exercise capacity in adult hemodialysis patients

Approved in Canada as Intradialytic Cycling for:

• Enhancement of physical function and quality of life in hemodialysis patients

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials

628

Recruited

209,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Published Research Related to This Trial

In a study involving 98 adults on maintenance hemodialysis, the timing of intradialytic cycling (either during the first or second half of hemodialysis) did not significantly affect the rate of intradialytic hypotension (IDH), indicating that cycling can be safely performed later in the session.

The study found no difference in symptomatic IDH or recovery time post-hemodialysis based on cycling timing, suggesting that late intradialytic cycling could be a viable option to enhance treatment without increasing risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Trial Examining the Impact of Timing of Intradialytic Cycling on Intradialytic Hypotension. Rossum, K., Hancock, E., Thompson, S., et al.[2023]

Intradialytic exercise, including aerobic and resistance training, significantly improves functional capacity in patients with end-stage renal disease undergoing hemodialysis, with effect sizes indicating substantial benefits in walking distance and muscle strength.

Combined exercise modalities not only enhance physical performance but also improve patients' perception of vitality, with minimal adverse events reported, suggesting a safe and effective intervention for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intradialytic exercise in end-stage renal disease: An umbrella review of systematic reviews and/or meta-analytical studies. Bündchen, DC., Sousa, H., Afreixo, V., et al.[2022]

A multicenter feasibility study involving 25 older hemodialysis patients (average age 73) showed that supervised intradialytic exercise is safe and feasible, with 79% agreeing to participate despite a 32% dropout rate.

Participants who completed the exercise program experienced significant improvements in physical capacity, mental health, depressive symptoms, and quality of sleep, indicating substantial clinical benefits from the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of an Intradialytic Combined Exercise Program Targeting Older Adults With End-Stage Renal Disease. Parent-Roberge, H., Deshayes, TA., Fortier, C., et al.[2022]

A randomized controlled trial involving 40 patients showed that adding functional training and counseling to intradialytic cycling significantly improved physical performance, particularly in the sit-to-stand test, handgrip strength, and flexibility after 16 weeks.

The improvements in physical performance were not only significant at the 8-week mark but were also maintained at 16 weeks, indicating that functional training effectively prepares patients for sustainable home exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kinesiologist-guided functional exercise in addition to intradialytic cycling program in end-stage kidney disease patients: a randomised controlled trial. Bogataj, Š., Pajek, J., Buturović Ponikvar, J., et al.[2021]

Intradialytic cycling exercise over 12 weeks significantly improved quality of life scores in hemodialysis patients, with notable increases in both generic and kidney disease-specific quality of life measures.

Patients who engaged in cycling exercise also experienced a shorter recovery time after dialysis sessions compared to those who did not exercise, indicating a beneficial impact on their overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the effect of intradialytic cycling exercise on quality of life and recovery time in hemodialysis patients: A randomized clinical trial. Moeinzadeh, F., Shahidi, S., Shahzeidi, S.[2023]

A study indicates that intradialytic exercise, such as cycling during hemodialysis, may help reduce episodes of demand ischemia (myocardial stunning) in patients with end-stage kidney disease, suggesting it is a safe option for rehabilitation.

The ongoing multicenter study aims to further assess the safety and quality of life benefits of intradialytic exercise, potentially paving the way for more effective rehabilitation programs for patients on hemodialysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinning the legs and blood: should intradialytic exercise be routinely offered during maintenance haemodialysis? Graham-Brown, MPM., Herrington, WG., Burton, JO.[2022]

Intradialytic exercise, particularly supervised light to moderate aerobic cycling, may help increase phosphate removal in hemodialysis patients, which is beneficial for those struggling to meet phosphate targets.

However, the overall impact of intradialytic exercise on dialysis adequacy, specifically regarding the clearance of urea and other middle molecules, remains unclear, indicating a need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of intradialytic exercise on hemodialysis adequacy: A systematic review. Kirkman, DL., Scott, M., Kidd, J., et al.[2020]

Intradialytic cycling was found to be feasible and acceptable for patients in a remote northern dialysis unit, with 43% of eligible patients participating regularly for an average of 2.5 months during their hemodialysis sessions.

Participants cycled for about 65 minutes per session, and the study highlighted important themes for successful implementation, such as community support and trust, which are crucial for encouraging physical activity among patients in challenging environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Intradialytic Cycling Program in a Remote Community Hemodialysis Unit: Mixed-Methods Analysis of Implementation. Kaminska, ME., Roots, RK., Singh, A.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9854908/

Evaluating the effect of intradialytic cycling exercise on ... [15,19] In the present study, we found that intradialytic cycling exercise significantly decreased dialysis recovery time. Although, the mechanisms through ...

2. bmcnephrol.biomedcentral.com bmcnephrol.biomedcentral.com/articles/10.1186/s12882-025-04381-z

The efficacy of different types of intradialytic exercise for ... Current evidence is insufficient to conclude that any specific type of intradialytic exercise significantly improves dialysis adequacy. However, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3214879/

Intradialytic Exercise Programs for Hemodialysis Patients This review aimed to investigate the beneficial effects of exercise during hemodialysis and also to introduce various intradialytic exercise programs and their ...

4. evidence.nejm.org evidence.nejm.org/doi/full/10.1056/EVIDoa2300057

Exercise during Hemodialysis in Patients with Chronic Kidney ... Twelve months of intradialytic exercise in patients with kidney failure significantly improved the STS60 compared with usual care.

5. bmcnephrol.biomedcentral.com bmcnephrol.biomedcentral.com/articles/10.1186/s12882-023-03158-6

The effect of intradialytic exercise on dialysis patient survival Intradialytic exercise performed for at least 60 min during thrice weekly dialysis sessions improves survival in adult patients receiving HD.

6. sciencedirect.com sciencedirect.com/science/article/pii/S2013251421001255

Impact and safety outcomes of an intradialytic physical ... We aimed to evaluate the impact and safety outcomes of the implementation of an intradialytic physical exercise program (IPE) by a multidisciplinary team ( ...

7. bmjopen.bmj.com bmjopen.bmj.com/content/9/1/e020633

Efficacy and safety of intradialytic exercise in ... Intradialytic exercise resulted in benefits in terms of improving haemodialysis adequacy, exercise capacity, depression and quality of life for haemodialysis.