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?

The goal of this study is to determine what happens to the heart muscle contraction when people cycle before their hemodialysis treatment. Will pre-dialysis exercise protect the heart from a decrease in pumping of the heart muscle (called stunning) that can happen during hemodialysis. We will study whether pre-dialysis exercise decreases heart stunning, decreases the number and severity of symptoms commonly associated with hemodialysis, and other outcomes

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.

Is intradialytic exercise safe for humans?

Intradialytic exercise, such as cycling during hemodialysis, is generally considered safe for patients with end-stage kidney disease. Studies have shown it can improve physical condition and does not increase the risk of heart issues during dialysis. ^{1 2 3 4 5}

How is the treatment Intradialytic Cycling different from other treatments for cardioprotection during hemodialysis?

Intradialytic Cycling is unique because it involves exercising on a stationary bike during hemodialysis sessions, which can improve heart health by stabilizing blood flow and reducing heart strain, unlike traditional treatments that do not incorporate exercise. ^{2 3 5 6 7}

What data supports the effectiveness of the treatment Intradialytic Cycling, Intradialytic Exercise, Intradialytic Cycling Therapy, Exercise During Hemodialysis?

Research shows that exercise during hemodialysis, like cycling, can improve muscle strength, endurance, and overall physical function in patients with kidney disease. It also helps improve nutrition and hydration status, and may reduce heart-related issues during dialysis, enhancing quality of life and recovery time. ^{1 2 3 5 8}

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

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]

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]

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 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]

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]

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 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]

Citations

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

A Randomized Trial Examining the Impact of Timing of Intradialytic Cycling on Intradialytic Hypotension. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Spinning the legs and blood: should intradialytic exercise be routinely offered during maintenance haemodialysis? [2022]

3. England 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. [2022]

4. Poland 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). [2013]

5. India 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. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of intradialytic exercise in haemodialysis patients: a systematic review and meta-analysis. [2020]

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

Hemodynamic Instability during Dialysis: The Potential Role of Intradialytic Exercise. [2018]

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

Effects of exercise training during hemodialysis. [2018]