HemodialysisNCT07905885
Cycling During Dialysis: A Feasibility and Safety Study
A study testing Supervised Intradialytic Cycling in people with Hemodialysis and Kidney Disease, End-Stage, run by Sunnybrook Health Sciences Centre.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis, Kidney Disease, End-Stage, Fatigue
- What is being tested?
- Supervised Intradialytic Cycling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2026to 28 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Receiving in-centre hemodialysis at Sunnybrook Health Sciences Centre (Bayview Campus) on a Monday, Wednesday and Friday schedule for at least 3 months
- Stable vital signs and target weight
- No hospitalization in the last 4 weeks
- Functioning arteriovenous fistula or graft, or a non-femoral central venous catheter
- Able to complete a six-minute walk test, and medical clearance for exercise from the treating nephrologist
- Cognitive capacity to follow real-time verbal instructions and communicate symptoms during cycling, OR enrollment through a designated substitute decision maker with ongoing participant assent and clinical safety oversight by the treating nephrologist
- Able to communicate in English during exercise sessions so nursing staff and the physiotherapist can monitor safety in real time; patients with limited English proficiency who otherwise meet all criteria are eligible with interpretation support (LanguageLine Solutions)
Who cannot join
- Unstable cardiovascular conditions
- Active infection
- Severe cognitive impairment
- Medical contraindications to exercise
- Anticipated kidney transplant or transfer to another dialysis unit Unstable cardiovascular conditions
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Berhanu Angaro, Bachelor of Science in Nursing contact
About this study
Official title: Implementing Intradialytic Cycling in Hemodialysis Care: A Prospective Feasibility and Safety Study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Hemodialysis, Kidney Disease, End-Stage, Fatigue
- Being tested
- Supervised Intradialytic Cycling
- Keywords
- Intradialytic cycling, Intradialytic exercise, Hemodialysis, Exercise during dialysis, Stationary cycling, Feasibility, Safety, Pilot study, Nursing-supervised exercise, Fatigue, Quality of life, Chronic kidney disease
- Medical subject headings
- Kidney Failure, Chronic, Fatigue, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised Intradialytic CyclingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Supervised Intradialytic Cycling | Experimental | 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. Receives: Behavioral: Supervised Intradialytic Cycling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 weeks (during the 3-month intervention)
Retention
Percentage of enrolled participants who complete the 3-month intervention and the end-of-study assessments.
Measured: 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.
Measured: Every cycling session over 12 weeks
Secondary outcomes (5)
Change in fatigue (Fatigue Severity Scale)
Change in the 9-item Fatigue Severity Scale score. Higher scores mean more fatigue.
Measured: 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.
Measured: 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.
Measured: Baseline and 12 weeks
Change in dialysis adequacy (Kt/V)
Change in Kt/V from routine monthly blood work.
Measured: Baseline, week 6, and 12 weeks
Participant satisfaction
Participant Satisfaction Questionnaire ratings of ease, safety, fit with dialysis, and willingness to recommend.
Measured: Final week of the study (about 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start20 Oct 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm study. All participants receive the same supervised bedside cycling program during hemodialysis, three times a week (Monday, Wednesday and Friday) for 3 months. There is no comparison group.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Berhanu Angaro, Bachelor of Science in Nursing, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07905885
- Sponsor's protocol ID
- 7297
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Intradialytic Cycling in Hemodialysis Care: A Prospective Feasibility and Safety Study
- ClinicalTrials.gov ID
- NCT07905885
- Acronym / sponsor ID
- 7297
- Conditions
- Hemodialysis, Kidney Disease, End-Stage, Fatigue
- Keywords
- Intradialytic cycling, Intradialytic exercise, Hemodialysis, Exercise during dialysis, Stationary cycling, Feasibility, Safety, Pilot study
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 20 Oct 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 30 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm study. All participants receive the same supervised bedside cycling program during hemodialysis, three times a week (Monday, Wednesday and Friday) for 3 months. There is no comparison group.
| Arm | Type | Receives |
|---|---|---|
| Supervised Intradialytic Cycling | Experimental | Behavioral: Supervised Intradialytic CyclingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 years or older
- Receiving in-centre hemodialysis at Sunnybrook Health Sciences Centre (Bayview Campus) on a Monday, Wednesday and Friday schedule for at least 3 months
- Stable vital signs and target weight
- No hospitalization in the last 4 weeks
- Functioning arteriovenous fistula or graft, or a non-femoral central venous catheter
Key exclusion criteria (5 listed)
- Unstable cardiovascular conditions
- Active infection
- Severe cognitive impairment
- Medical contraindications to exercise
- Anticipated kidney transplant or transfer to another dialysis unit Unstable cardiovascular conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised Intradialytic CyclingSupervised 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. | Behavioural | Supervised Intradialytic Cycling |
Primary outcome
Recruitment rate
Time frame: Recruitment period (up to 3 months, approximately October to December 2026)
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.
Adherence to the cycling program
Time frame: 12 weeks (during the 3-month intervention)
Percentage of scheduled supervised cycling sessions that each participant completes, based on the Nursing Monitoring Form and Exercise Prescription Log.
Retention
Time frame: 12 weeks
Percentage of enrolled participants who complete the 3-month intervention and the end-of-study assessments.
Number and type of adverse events during cycling sessions
Time frame: Every cycling session over 12 weeks
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.
5 secondary outcomes
Change in fatigue (Fatigue Severity Scale)
Time frame: Baseline and 12 weeks
Change in quality of life (KDQOL-SF)
Time frame: Baseline and 12 weeks
Change in walking distance (6-Minute Walk Test)
Time frame: Baseline and 12 weeks
Change in dialysis adequacy (Kt/V)
Time frame: Baseline, week 6, and 12 weeks
Participant satisfaction
Time frame: Final week of the study (about 12 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Berhanu Angaro, Bachelor of Science in Nursing contact
Berhanu Angaro, Bachelor of Science in Nursing principal investigator
Sunnybrook Health Sciences Centre
Questions about this trial
What is this clinical trial studying?
A study testing Supervised Intradialytic Cycling in people with Hemodialysis and Kidney Disease, End-Stage, run by Sunnybrook Health Sciences Centre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Berhanu Angaro, Bachelor of Science in Nursing (416-480-6100 ext. 4488, Berhanu.Angaro@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: Recruitment period (up to 3 months, approximately October to December 2026)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.