Exercise Preconditioning for Cardioprotection During Hemodialysis

Overseen By Kathy Koyle

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Lawson Health Research Institute

Disqualifiers: Vigorous exercise, Over 79, Coronary syndrome, Arrhythmia, 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: 4

Duration: 4 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether exercising before dialysis can protect the heart from "stunning," a temporary decrease in the heart's pumping ability. Researchers aim to determine if intradialytic cycling (exercise during dialysis) can reduce heart stunning and improve symptoms often experienced during dialysis. Participants will be divided into two groups to assess the effects of exercising on different days. This study may suit individuals who have been on hemodialysis for at least three months and have received medical clearance to exercise. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could enhance dialysis care.

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

Research has shown that exercising while on dialysis, known as intradialytic cycling, is generally safe for patients. One study found that this exercise can help people recover faster after dialysis. Another study highlighted benefits such as improved exercise ability and better quality of life for those on dialysis. Importantly, these studies reported no serious side effects.

These findings suggest that exercising during dialysis is well-tolerated and might improve heart health. However, more detailed studies are needed to fully understand its long-term safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about intradialytic cycling for cardioprotection during hemodialysis because it offers a novel way to protect the heart using a non-pharmacological approach. Unlike standard dialysis treatments that don't include exercise, this method involves patients cycling on a stationary bike during their dialysis sessions. The goal is to precondition the heart by improving blood flow and reducing cardiovascular stress, potentially leading to better heart health without additional medication. This approach could complement existing treatments, like medications for blood pressure and heart health, with a straightforward and active intervention.

What evidence suggests that intradialytic cycling might be an effective treatment for heart stunning during hemodialysis?

Studies have shown that exercising on a stationary bike during dialysis, known as intradialytic cycling, improves heart and blood vessel health. It facilitates blood flow through arteries, enhances blood pressure, and balances the time between heartbeats. Research also indicates that this exercise makes dialysis more effective by clearing out toxins more efficiently. Additionally, it has been linked to better physical function and quality of life for those undergoing regular dialysis. In this trial, participants will be randomized into two groups to receive the intradialytic cycling intervention at different times. This evidence suggests that intradialytic cycling might protect the heart and improve overall outcomes for patients on dialysis. ^{2 6 7 8 9}

Who Is on the Research Team?

Christopher McIntyre

Principal Investigator

London Health Sciences Centre Research Institute

Are You a Good Fit for This Trial?

This trial is for individuals who are undergoing hemodialysis, a treatment for kidney failure. Participants should be willing to exercise before their dialysis sessions. Specific eligibility criteria are not provided, but typically include factors like age range, overall health status, and the absence of conditions that could interfere with the study or pose risks.

Inclusion Criteria

Willing and able to provide informed consent

Assessed to be safe and able to exercise by unit HD Nephrologist

I have been on hemodialysis for at least 3 months.

Exclusion Criteria

Regular vigorous exercise outside of hemodialysis

Intradialytic exercise less than 3 months

Poor echogenicity

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo exercise preconditioning before hemodialysis to assess its impact on cardiac function

4 weeks

4 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Intradialytic Cycling

Trial Overview The study is testing if cycling before hemodialysis can protect the heart from damage during treatment. It aims to see whether this 'preconditioning' exercise can prevent a decrease in heart muscle pumping ability and reduce symptoms related to hemodialysis.

How Is the Trial Designed?

Group I: Randomization Order 2 Experimental Treatment 1 Intervention

Participants will be randomized into one of the two groups indicating the order in which they will receive the exercise intervention. Randomization Order 2 will receive the exercise treatment on the first day of the fourth week of the study. The other three days without exercise will consist of standard dialysis sessions with study procedures.

Group II: Randomization Order 1 Experimental Treatment 1 Intervention

Participants will be randomized into one of the two groups indicating the order in which they will receive the exercise intervention. Randomization Order 1 will receive the exercise treatment on the first day of the first week of the study. The other three days without exercise will consist of standard dialysis sessions with study procedures.

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?

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

686

Recruited

427,000+

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

678

Recruited

421,000+

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

668

Recruited

424,000+

Published Research Related to This Trial

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]

Intravenous hypotension (IDH) occurs in 20-30% of patients during hemodialysis, leading to temporary heart issues and long-term heart function problems, which increase the risk of cardiovascular death in patients with end-stage renal disease (ESRD).

Current medical treatments for managing hemodynamic instability during hemodialysis are not very effective, but intradialytic exercise training may offer a promising non-medical approach to stabilize cardiovascular health and reduce complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hemodynamic Instability during Dialysis: The Potential Role of Intradialytic Exercise. McGuire, S., Horton, EJ., Renshaw, D., et al.[2018]

A 6-month study involving 10 patients with end-stage renal disease (ESRD) undergoing hemodialysis showed that stationary cycling during dialysis is safe and effective, leading to improved nutritional status as indicated by increased serum albumin levels.

Regular cycling also enhanced dialysis adequacy, as evidenced by improved Kt/V and nPCR values, while reducing inflammation markers like serum CRP, suggesting overall health benefits for ESRD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition and hydration status improve with exercise training using stationary cycling during hemodialysis (HD) in patients with end-stage renal disease (ESRD). Załuska, A., Załuska, WT., Bednarek-Skublewska, A., et al.[2013]

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]

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]

In a randomized controlled trial involving 76 haemodialysis patients, a 12-week intradialytic cycling exercise program significantly improved physical functional performance, including increased 6-minute walk distance and enhanced muscle strength.

The exercise intervention was found to be safe and effective, demonstrating notable improvements in sit-to-stand-to-sit performance, which correlated with better walking distance outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Twelve-week intradialytic cycling exercise improves physical functional performance with gain in muscle strength and endurance: a randomized controlled trial. Yeh, ML., Wang, MH., Hsu, CC., et al.[2022]

A 6-month exercise training program on a stationary bicycle during hemodialysis significantly increased maximal oxygen consumption by 23% in the exercise group of 14 patients, demonstrating improved exercise capacity.

The program was safe and feasible, with some hypertensive patients reducing or stopping their antihypertensive medications, indicating potential benefits for blood pressure control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of exercise training during hemodialysis. Painter, PL., Nelson-Worel, JN., Hill, MM., et al.[2018]

Intradialytic exercise significantly improved dialysis adequacy and exercise capacity in haemodialysis patients, as shown by increased Kt/V and peak oxygen consumption in a systematic review of 27 RCTs involving 1215 subjects.

The exercise program also alleviated depression and improved quality of life, evidenced by better scores on the SF-36 physical component, while showing no increase in adverse events compared to no exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of intradialytic exercise in haemodialysis patients: a systematic review and meta-analysis. Pu, J., Jiang, Z., Wu, W., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11000728/

Effect of Intradialytic Exercise on Cardiovascular Outcomes in ... Intradialytic exercise improves cardiovascular outcomes, including arterial resistance, BP, and heart rate variability. Clinicians should consider including ...

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

The efficacy of different types of intradialytic exercise for ... To systematically review and compare the effects of different intradialytic exercises on dialysis adequacy in patients undergoing hemodialysis.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02753868

Acute Effects of Intradialytic Exercise on Cardiovascular ... The purpose of this study is to examine the effect of cycling at mild to moderate intensity during hemodialysis treatment on cardiovascular function in a ...

4. journals.lww.com journals.lww.com/md-journal/fulltext/2016/07050/intradialytic_aerobic_cycling_exercise_alleviates.71.aspx

Intradialytic aerobic cycling exercise alleviates... Recently, exercise has been shown to improve cardiovascular outcomes, dialysis efficacy, physical function, health-related quality of life, and high-sensitivity ...

5. erar.springeropen.com erar.springeropen.com/articles/10.1186/s43166-025-00334-4

Effect of intra-dialytic exercise on hemodialysis session ... Moderate-intensity IDE session improved dialysis efficacy, promoting better electrolyte balance and uremic toxin clearance in ESRD patients on HD.

6. 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 ...

7. 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 ( ...

8. 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.

9. journals.lww.com journals.lww.com/kidney360/fulltext/2024/03000/effect_of_intradialytic_exercise_on_cardiovascular.8.aspx

Effect of Intradialytic Exercise on Cardiovascular Outcomes ... Intradialytic exercise may mitigate intradialytic myocardial stunning and improve cardiovascular structure and function.