An interventional study of Supervised Intradialytic Cycling in Hemodialysis, Kidney Disease, End-Stage and Fatigue, sponsored by Sunnybrook Health Sciences Centre. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Sunnybrook Health Sciences Centre · Not applicable, Interventional, and Health services research
People who receive hemodialysis sit for about 4 hours, three times a week, and often feel tired and weak. Exercise can help, but many patients find it hard to exercise on their own. Cycling on a stationary bike during dialysis has been shown to be safe in other hospitals, but it is not yet offered at Sunnybrook.
This study will find out if a supervised cycling program during dialysis is practical and safe at Sunnybrook Health Sciences Centre (Bayview Campus). Twelve adults who have dialysis on Mondays, Wednesdays and Fridays will cycle on a bedside exercise bike during their dialysis sessions, three times a week for 3 months. Trained nurses and a physiotherapist will set up the bike and watch every session, including checking heart rate, blood pressure and oxygen levels. We will look at how many patients join and stay in the study, how many cycling sessions they complete, and whether any safety problems happen.
We will also look at changes in tiredness, walking ability, quality of life, and how well dialysis cleans the blood. At the end, patients and nurses will give feedback on the program.
The results will help decide if cycling can be added to regular dialysis care and will help plan a larger study.
This is a single-site, single-arm, prospective feasibility and safety study. It is not designed to test whether cycling works better than usual care. Its purpose is to assess whether supervised intradialytic cycling can be delivered safely within routine hemodialysis workflow at the Hemodialysis Unit, Sunnybrook Health Sciences Centre (Bayview Campus), and to generate data to plan a larger randomized trial.
Intervention: Participants cycle on a bedside cycle ergometer (Monark 881E Rehab Trainer or equivalent) during their usual Monday, Wednesday and Friday dialysis sessions for about 3 months (12 weeks). Hemodialysis nurses set up and calibrate the equipment with the study physiotherapist and supervise every session. Heart rate, blood pressure and oxygen saturation are recorded before cycling, at 15 minutes, at 30 minutes (or at the end of a shorter session), immediately after cycling, and 15 minutes after cycling. Nurses stop the session immediately if predefined stopping criteria occur (for example chest pain, symptomatic hypotension, tachycardia, oxygen saturation below 92%, severe cramping, or vascular access problems). All adverse events are documented and reported to the Principal Investigator and to the Research Ethics Board within 24 hours.
Assessments: At baseline and at the end of the study, participants complete a six-minute walk test (administered by the physiotherapist before dialysis), the Fatigue Severity Scale, and the Kidney Disease Quality of Life Short Form. Dialysis adequacy (Kt/V) is taken from routine monthly blood work. A midpoint review at about week 6 includes Kt/V, adverse event and adherence records. At the end of the study, participants complete a satisfaction questionnaire and families/caregivers partake in a brief semi-structured interview, and participating dialysis nurses complete a satisfaction questionnaire about equipment setup, workload, training, supervision confidence, and challenges and opportunities for routine implementation.
Analysis: Descriptive statistics will be used for feasibility (recruitment rate, adherence, retention) and safety (adverse events). Pre-post changes in clinical and patient-reported measures will be explored descriptively, without hypothesis testing.
Patient and family partners advise on study design, recruitment and educational materials.
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
This study's planned enrollment of 12 is below the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Sunnybrook Health Sciences Centre is the lead sponsor of 584 studies on the registry; 135 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants cycle on a bedside cycle ergometer during hemodialysis three times a week (Monday, Wednesday, Friday) for 3 months (12 weeks), supervised by trained hemodialysis nurses and a physiotherapist. Vital signs are monitored throughout each session, and sessions stop if predefined safety criteria occur.
Behavioral: Supervised Intradialytic Cycling
Supervised stationary cycling on a bedside cycle ergometer (Monark 881E Rehab Trainer or equivalent) during routine hemodialysis, three sessions per week for 3 months. Nurses set up and calibrate the equipment with the study physiotherapist, record heart rate, blood pressure and oxygen saturation before, during and after cycling, and stop the session if safety criteria are met (for example chest pain, symptomatic hypotension, or access problems). Adverse events are documented and reported.
Recruitment rate
Number of eligible patients who consent to take part, reported as the number enrolled per month and as the percentage of eligible patients approached who enroll.
Time frame: Recruitment period (up to 3 months, approximately October to December 2026)
Adherence to the cycling program
Percentage of scheduled supervised cycling sessions that each participant completes, based on the Nursing Monitoring Form and Exercise Prescription Log.
Time frame: 12 weeks (during the 3-month intervention)
Retention
Percentage of enrolled participants who complete the 3-month intervention and the end-of-study assessments.
Time frame: 12 weeks
Number and type of adverse events during cycling sessions
Adverse events recorded by nurses on the Adverse Event Report Form, including symptomatic hypotension, chest pain, tachycardia, low oxygen saturation, severe cramping, and vascular access problems such as needle dislodgement, plus sessions stopped early for safety criteria.
Time frame: Every cycling session over 12 weeks
Change in fatigue (Fatigue Severity Scale)
Change in the 9-item Fatigue Severity Scale score. Higher scores mean more fatigue.
Time frame: Baseline and 12 weeks
Change in quality of life (KDQOL-SF)
Change in Kidney Disease Quality of Life Short Form scores. Higher scores mean better quality of life.
Time frame: Baseline and 12 weeks
Change in walking distance (6-Minute Walk Test)
Change in distance walked in 6 minutes, in metres, measured by the physiotherapist.
Time frame: Baseline and 12 weeks
Change in dialysis adequacy (Kt/V)
Change in Kt/V from routine monthly blood work.
Time frame: Baseline, week 6, and 12 weeks
Participant satisfaction
Participant Satisfaction Questionnaire ratings of ease, safety, fit with dialysis, and willingness to recommend.
Time frame: Final week of the study (about 12 weeks)
Nurse satisfaction and perceived feasibility
Nurse Satisfaction Questionnaire on equipment setup and calibration, training, supervision confidence, workload, and challenges and opportunities for routine care.
Time frame: End of study (about 12 weeks)
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be shared. This is a small single-site feasibility study (12 participants), so even de-identified individual records could allow participants to be identified. Participant consent does not include sharing data with other researchers. Aggregate results will be published and reported to the registry.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Apr 2027, 6 months later.
Of 347 non-industry interventional studies with no phase under Kidney Failure, Chronic, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 47. This study's planned 6 months is below that.
Counting every sponsor, half of 425 studies reached it within 23 months; a quarter within 8 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sunnybrook Health Sciences Centre →