DialysisNCT07119593
Exercise Intensity
A study testing Intradialytic Cycling in people with Dialysis and Cardioprotection, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Patients receiving regular hemodialysis (HD) treatments are at a higher risk of cardiovascular events and death as HD can cause a decrease in the pumping of the heart during treatment called 'stunning'. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Dialysis, Cardioprotection
- What is being tested?
- Intradialytic Cycling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 22 Sep 2025to 31 Dec 2026
- 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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be on chronic hemodialysis for at least 3 months
- Age ≥ 18 years of age
- Willing and able to provide informed consent
Who cannot join
- Regular vigorous exercise outside hemodialysis
- > 79 years of age
- Intradialytic exercise in the past 3 months
- Poor echogenicity
- Acute coronary syndrome in the past 3 months
- Unstable arrhythmia/angina
Show all 15Show fewer
- Shortness of breath at rest or with minimal activity
- Symptomatic hypoglycemia (>2x/week in the week prior to enrolment)
- Symptomatic peripheral arterial disease
- Unable or deemed unsafe to exercise for any reason
- Severe musculoskeletal or orthopedic conditions
- Aortic stenosis
- Hypertrophic cardiopathy
- Severe pulmonary hypertension
- Symptomatic hypertension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Boosting Myocardial Preconditioning With High-Intensity Intradialytic Exercise: A Preliminary Study
Patients receiving regular hemodialysis (HD) treatments are at a higher risk of cardiovascular events and death as HD can cause a decrease in the pumping of the heart during treatment called 'stunning'. Intradialytic exercise has emerged as a safe and effective non-drug approach to improve cardiovascular health and is now recommended for patients undergoing HD. It is currently advised that HD patients engage in at least 30 minutes of moderate to vigorous exercise three times per week. This study will evaluate the impact of exercise intensity in the HD population and determine if high impact exercise can offer better protection to the heart against HD-induced myocardial stunning.
Read the detailed description
This will be the first randomized, cross-controlled trial evaluating the impact of exercise intensity in the HD population. If the efficacy of cardiovascular protection is proven, it could be developed as a therapeutic option in the dialysis population.
- Conditions
- Dialysis, Cardioprotection
- Being tested
- Intradialytic Cycling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intradialytic CyclingOther
Intradialytic exercise has emerged as a safe and effective non-drug therapeutic approach to improve cardiovascular health and is now recommended for people undergoing hemodialysis treatment. Administration of a higher intensity exercise could offer better cardio-protective mechanisms and if the efficacy of cardiovascular protection is proven, it could be developed as a therapeutic option in the dialysis population.
| Study group | Role | What they receive |
|---|---|---|
| Randomization Order 1 | Other | Participants will be randomized into one of the three conditions indicating the order in which they will receive the exercise intervention. Randomization Order 1 will receive control (no exercise) week one. Week 2 the participant will have a moderate intensity exercise treatment and week three the participant will have a high intensity exercise treatment. All sessions (i.e. HD-Cont, HD-Mod and HD-High) will be performed on one of the patient's three days of weekly dialysis. Each patient will consistently perform all sessions on the same day of dialysis throughout the study. The three sessions will be separate by at least one week to avoid potential carryover effects. Receives: Other: Intradialytic Cycling |
| Randomization Order 2 | Experimental | Participants will be randomized into one of the three conditions indicating the order in which they will receive the exercise intervention. Randomization Order 2 will receive moderate intensity exercise week one. Week 2 the participant will have high intensity exercise and week three the participant will have control (no exercise). All sessions (i.e. HD-Cont, HD-Mod and HD-High) will be performed on one of the patient's three days of weekly dialysis. Each patient will consistently perform all sessions on the same day of dialysis throughout the study. The three sessions will be separate by at least one week to avoid potential carryover effects. Receives: Other: Intradialytic Cycling |
| Randomization 3 | Experimental | Participants will be randomized into one of the three conditions indicating the order in which they will receive the exercise intervention. Randomization Order 3 will receive high intensity exercise week one. Week 2 the participant will have control (no exercise) and week three the participant will have a moderate intensity exercise treatment. All sessions (i.e. HD-Cont, HD-Mod and HD-High) will be performed on one of the patient's three days of weekly dialysis. Each patient will consistently perform all sessions on the same day of dialysis throughout the study. The three sessions will be separate by at least one week to avoid potential carryover effects. Receives: Other: Intradialytic Cycling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the number of left ventricular segments undergoing a greater than 20% reduction in longitudinal strain as detected by echocardiogram.
An echocardiogram will be completed pre-hemodialysis (HD) treatment and at peak hemodynamic stress (30 minutes before the end of HD treatment) at each of the study sessions. Images will be captured in the left lateral position and standard apical 4, and 2 chamber views will be recorded for analysis using automated speckle-training software. (EchoPac, GE Healthcare)
Measured: Week 1 to Week 3
Secondary outcomes (5)
Evaluate potential targets of exercise induced cardio protection by evaluating their effects on endothelial function.
Endothelial function will be assessed by measuring the dilatory response of the brachial artery to increased blood flow generated by reactive hyperemia in the downstream forearm. At each study session participants are placed in the supine position and the brachial artery of the non-dominant arm, or the non-distended arm is scanned in longitudinal section using a 12 MHz linear transducer connected to a Vivid Q echograph (GE, /USA) supplemented by an electrocardiogram (ECG).
Measured: Week 1 to Week 3
Evaluate whether the increase in exercise intensity leads to a differential modulation of potential cardioprotective mechanisms, by evaluating their effects on hemodynamic responses (Blood Pressure)
Systolic blood pressure (SBP), Diastolic blood pressure (DBP) and mean arterial pressure (MAP) will be measured using an automated blood pressure monitor integrated into the dialysis machine. Values will be monitored throughout each study visit.
Measured: Week 1 to week 3
Evaluate whether the increase in exercise intensity leads to a differential modulation of potential cardioprotective mechanisms, by evaluating their effects on hemodynamic responses (CV Insight Monitoring)
The CV Insight contact device is non-invasive continuous hemodynamic real time monitoring system use to assess cardiovascular and respiratory status using percutaneous photoplethysmography. The device will be attached to the right of the patient's forehead midline., approximately 2.5cm above the level of the nose pre-dialysis and will remain intact until the patient is disconnected from the dialysis machine at each study session. Once attached, baseline recording will be obtained, and hemodynamic data will continuously be captured.
Measured: Week 1 to Week 3
Evaluate whether the increase in exercise intensity leads to a differential modulation of potential cardioprotective mechanisms, by evaluating their effects on hemodynamic responses (Finapres)
The Finometer utilizes a finger-cuff method to detect beat-to-beat changes in digital arterial diameter using an infrared photoplethysmography. The time averaged data is subsequently downloaded to a computer-based analysis program for analysis. The finger-cuff will be placed on the participant's index finger at each study visit and will remain in place through the entirety of the visit.
Measured: Week 1 to Week 3
Evaluate whether the increase in exercise intensity leads to a differential modulation of potential cardioprotective mechanisms, focusing on blood markers.
Blood samples will be collected from the participants dialysis access before HD and at peak stress at each study visit for biochemistry, proteomic analysis and translational approach.
Measured: Week 1 to Week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start22 Sep 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DialysisStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Open label, randomized, controlled, crossover trial with 3 conditions.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chris McIntyre, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Chris McIntyre, MBBS DM, Principal investigator, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07119593
- Sponsor's protocol ID
- 15956
- Status last verified
- Apr 2026
- First submitted
- 19 Jun 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Not Yet Determined
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Boosting Myocardial Preconditioning With High-Intensity Intradialytic Exercise: A Preliminary Study
- ClinicalTrials.gov ID
- NCT07119593
- Acronym / sponsor ID
- 15956
- Conditions
- Dialysis, Cardioprotection
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 22 Sep 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Aug 2025 (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.
Patients receiving regular hemodialysis (HD) treatments are at a higher risk of cardiovascular events and death as HD can cause a decrease in the pumping of the heart during treatment called 'stunning'. Intradialytic exercise has emerged as a safe and effective non-drug approach to improve cardiovascular health and is now recommended for patients undergoing HD. It is currently advised that HD patients engage in at least 30 minutes of moderate to vigorous exercise three times per week. This study will evaluate the impact of exercise intensity in the HD population and determine if high impact exercise can offer better protection to the heart against HD-induced myocardial stunning.
Detailed description
This will be the first randomized, cross-controlled trial evaluating the impact of exercise intensity in the HD population. If the efficacy of cardiovascular protection is proven, it could be developed as a therapeutic option in the dialysis population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Open label, randomized, controlled, crossover trial with 3 conditions.
| Arm | Type | Receives |
|---|---|---|
| Randomization Order 1 | Other | Other: Intradialytic CyclingParticipants will be randomized into one of the three conditions indicating the order in which they will receive the exercise intervention. Randomization Order 1 will receive control (no exercise) week one. Week 2 the participant will have a moderate intensity exercise treatment and week three the participant will have a high intensity exercise treatment. All sessions (i.e. HD-Cont, HD-Mod and HD-High) will be performed on one of the patient's three days of weekly dialysis. Each patient will consistently perform all sessions on the same day of dialysis throughout the study. The three sessions will be separate by at least one week to avoid potential carryover effects. |
| Randomization Order 2 | Experimental | Other: Intradialytic CyclingParticipants will be randomized into one of the three conditions indicating the order in which they will receive the exercise intervention. Randomization Order 2 will receive moderate intensity exercise week one. Week 2 the participant will have high intensity exercise and week three the participant will have control (no exercise). All sessions (i.e. HD-Cont, HD-Mod and HD-High) will be performed on one of the patient's three days of weekly dialysis. Each patient will consistently perform all sessions on the same day of dialysis throughout the study. The three sessions will be separate by at least one week to avoid potential carryover effects. |
| Randomization 3 | Experimental | Other: Intradialytic CyclingParticipants will be randomized into one of the three conditions indicating the order in which they will receive the exercise intervention. Randomization Order 3 will receive high intensity exercise week one. Week 2 the participant will have control (no exercise) and week three the participant will have a moderate intensity exercise treatment. All sessions (i.e. HD-Cont, HD-Mod and HD-High) will be performed on one of the patient's three days of weekly dialysis. Each patient will consistently perform all sessions on the same day of dialysis throughout the study. The three sessions will be separate by at least one week to avoid potential carryover effects. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must be on chronic hemodialysis for at least 3 months
- Age ≥ 18 years of age
- Willing and able to provide informed consent
Key exclusion criteria (15 listed)
- Regular vigorous exercise outside hemodialysis
- > 79 years of age
- Intradialytic exercise in the past 3 months
- Poor echogenicity
- Acute coronary syndrome in the past 3 months
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 |
|---|---|---|
| Intradialytic CyclingIntradialytic exercise has emerged as a safe and effective non-drug therapeutic approach to improve cardiovascular health and is now recommended for people undergoing hemodialysis treatment. Administration of a higher intensity exercise could offer better cardio-protective mechanisms and if the efficacy of cardiovascular protection is proven, it could be developed as a therapeutic option in the dialysis population. | Other | Randomization 3, Randomization Order 1, Randomization Order 2 |
Primary outcome
Change in the number of left ventricular segments undergoing a greater than 20% reduction in longitudinal strain as detected by echocardiogram.
Time frame: Week 1 to Week 3
An echocardiogram will be completed pre-hemodialysis (HD) treatment and at peak hemodynamic stress (30 minutes before the end of HD treatment) at each of the study sessions. Images will be captured in the left lateral position and standard apical 4, and 2 chamber views will be recorded for analysis using automated speckle-training software. (EchoPac, GE Healthcare)
5 secondary outcomes
Evaluate potential targets of exercise induced cardio protection by evaluating their effects on endothelial function.
Time frame: Week 1 to Week 3
Evaluate whether the increase in exercise intensity leads to a differential modulation of potential cardioprotective mechanisms, by evaluating their effects on hemodynamic responses (Blood Pressure)
Time frame: Week 1 to week 3
Evaluate whether the increase in exercise intensity leads to a differential modulation of potential cardioprotective mechanisms, by evaluating their effects on hemodynamic responses (CV Insight Monitoring)
Time frame: Week 1 to Week 3
Evaluate whether the increase in exercise intensity leads to a differential modulation of potential cardioprotective mechanisms, by evaluating their effects on hemodynamic responses (Finapres)
Time frame: Week 1 to Week 3
Evaluate whether the increase in exercise intensity leads to a differential modulation of potential cardioprotective mechanisms, focusing on blood markers.
Time frame: Week 1 to Week 3
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 29 Apr 2026.
- Individual participant dataSharing planned: Yes. Not Yet Determined
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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. This study is not recruiting at the moment.
Chris McIntyre, MBBS DM principal investigator
London Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intradialytic Cycling in people with Dialysis and Cardioprotection, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 3 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the number of left ventricular segments undergoing a greater than 20% reduction in longitudinal strain as detected by echocardiogram. (time frame: Week 1 to Week 3). 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 29 Apr 2026.