Exercise During Dialysis for Hemodialysis Patients

Recruiting at 4 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

160 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Exercise During Dialysis for Hemodialysis Patients?

Research shows that intradialytic cycling, a form of exercise during dialysis, can improve physical function, such as the ability to stand up from a sitting position, and increase handgrip strength in patients with end-stage kidney disease. Additionally, it may help reduce heart-related issues during dialysis and improve overall quality of life. ^{1 2 3 4 5}

Is exercise during dialysis safe for hemodialysis patients?

Research shows that exercise during dialysis, like intradialytic cycling, is generally safe for patients with end-stage kidney disease. Studies have found that it can even reduce heart stress during dialysis and improve quality of life without significant adverse events. ^{1 2 3 6 7}

How is the treatment 'Exercise During Dialysis' different from other treatments for hemodialysis patients?

Exercise During Dialysis, specifically intradialytic cycling, is unique because it involves patients exercising on a stationary bike while undergoing dialysis, which can improve physical fitness and potentially enhance the removal of certain waste products from the blood. This approach uses the otherwise inactive time during dialysis sessions to provide rehabilitation benefits and may help address cardiovascular risks and physical deconditioning in patients. ^{1 2 3 5 8}

What is the purpose of this trial?

The purpose of this study is to determine the effect of a 12-week cycling during hemodialysis program on hemodialysis-induced myocardial stunning in adult individuals receiving hemodialysis.

Research Team

Clara Bohm, MD, MPH

Principal Investigator

University of Manitoba

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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]

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]

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, 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]

References

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

Kinesiologist-guided functional exercise in addition to intradialytic cycling program in end-stage kidney disease patients: a randomised controlled trial. [2021]

3. England pubmed.ncbi.nlm.nih.gov

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

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

Feasibility of Intradialytic Cycling Program in a Remote Community Hemodialysis Unit: Mixed-Methods Analysis of Implementation. [2023]

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

Feasibility of an Intradialytic Combined Exercise Program Targeting Older Adults With End-Stage Renal Disease. [2022]

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

Intradialytic exercise in end-stage renal disease: An umbrella review of systematic reviews and/or meta-analytical studies. [2022]

7. 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]

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

The effects of intradialytic exercise on hemodialysis adequacy: A systematic review. [2020]