HemodialysisNCT06735378
Exercise Preconditioning to Protect Against Dialysis-induced Cardiac Injury
A study testing Intradialytic Cycling in people with Hemodialysis 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
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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Hemodialysis, Cardioprotection
- What is being tested?
- Intradialytic Cycling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 20 Jan 2025to 31 Dec 2025
- 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 or older
- willing and able to provide informed consent
- assessed to be safe and able to exercise by unit HD Nephrologist
Who cannot join
- regular vigorous exercise outside of hemodialysis
- over 79 years of age
- intradialytic exercise < 3 months
- poor echogenicity
- acute coronary syndrome in the past 3 months
- unstable arrhythmia/angina
- shortness of breath at rest or with minimal activity
- symptomatic hypoglycemia (>2x/week in the week prior to enrolment)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
London Health Sciences Centre
London, Ontario, N6A 5W9
About this study
Official title: Exercise Preconditioning to Protect Against Dialysis-induced Cardiac Injury in Hemodialysis Patients: a Randomized Controlled 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
Read the detailed description
This will be the first randomized crossover-controlled trial with two experimental conditions assessing the impact of exercise preconditioning in the HD population. If proven effective exercise preconditioning could be developed as a therapeutic option to reduce rates of heart failure in the dialysis population.
- Conditions
- Hemodialysis, Cardioprotection
- Being tested
- Intradialytic Cycling
- Keywords
- Cardioprotection, Preconditioning Exercise, Hemodialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intradialytic CyclingOther
The impact of interdialytic exercise on cardio protection during HD has never been studied. This approach may enhance cardiovascular benefits and overall physical fitness, thereby contributing to better health outcomes in individuals undergoing HD.
| Study group | Role | What they receive |
|---|---|---|
| Randomization Order 1 | Experimental | 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. Receives: Other: Intradialytic Cycling |
| Randomization Order 2 | Experimental | 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. 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 min before the end of HD treatment) at each of the four study sessions. Images will be captured in the left lateral position and standard apical 4, 2, and 3 chamber views will be recorded for analysis using automated speckle-tracking software (EchoPac, GE Healthcare)
Measured: week 1 to week 4
Secondary outcomes (7)
Evaluate potential targets of preconditioning by exercise-induced cardio protection by focusing on hemodynamics (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.
Measured: week 1 to week 4
Evaluate potential targets of preconditioning by exercise-induced cardio protection focusing on hemodynamics (CV Insight Monitoring),
The CV Insight contact device is a non-invasive continuous hemodynamic real time monitoring system used to assess cardiovascular and respiratory status using percutaneous photoplethysmography. The device will be attached to the right of the patient's forehead midline, approximately 2.5 cm 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 be continuously captured.
Measured: week 1 to week 4
Evaluate potential targets of preconditioning by exercise-induced cardioprotection, focusing on hemodynamics (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 throughout the entire study visit
Measured: week 1 to week 4
Evaluate potential targets of preconditioning by exercise-induced cardio protection, focusing on blood markers
Blood samples will be collected from the participants dialysis access. Before HD and at peak-stress of each study session, will be collected for biochemistry, proteomic analysis and translational approach.
Measured: week 1 to week 4
Evaluate potential targets of preconditioning by exercise-induced cardio protection, focusing on erythrocyte deformability
Blood samples will be collected from the participants dialysis access. Before HD and at peak-stress of each study session for analysis of erythrocyte deformability which indicates microcirculation efficiency
Measured: week 1 to week 4
Evaluate potential targets of preconditioning by exercise-induced cardio protection, focusing on endothelial function
Endothelial function is 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 4
Evaluate potential targets of preconditioning by exercise-induced cardioprotection, focusing on proteomic analysis.
Proteomic alterations in plasma are important in the inflammatory response to ischemia-reperfusion (IR) injury. Blood Samples (plasma) will be collected pre and peak dialysis at each study session for the analysis of changes induced by exercise preconditioning, with the aim of identifying new potential targets for cardio protection.
Measured: week 1 to week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start20 Jan 2025
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Dec 2025 (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 London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Open label, randomized, controlled, crossover trial with 2 conditions and 4 dialysis sessions.
- Masking
- None (open label)
- Enrolment
- 30 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
- Investigators
- Christopher McIntyre, Principal investigator, London Health Sciences Centre Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06735378
- Sponsor's protocol ID
- 15393
- Status last verified
- Jan 2025
- First submitted
- 26 Nov 2024
- Last updated
- 22 Jan 2025
- 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 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Preconditioning to Protect Against Dialysis-induced Cardiac Injury in Hemodialysis Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06735378
- Acronym / sponsor ID
- 15393
- Conditions
- Hemodialysis, Cardioprotection
- Keywords
- Cardioprotection, Preconditioning Exercise, Hemodialysis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 Dec 2024 (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.
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
Detailed description
This will be the first randomized crossover-controlled trial with two experimental conditions assessing the impact of exercise preconditioning in the HD population. If proven effective exercise preconditioning could be developed as a therapeutic option to reduce rates of heart failure in the dialysis population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label, randomized, controlled, crossover trial with 2 conditions and 4 dialysis sessions.
| Arm | Type | Receives |
|---|---|---|
| Randomization Order 1 | Experimental | Other: Intradialytic CyclingParticipants 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. |
| Randomization Order 2 | Experimental | Other: Intradialytic CyclingParticipants 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. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- must be on chronic hemodialysis for at least 3 months
- age 18 years or older
- willing and able to provide informed consent
- assessed to be safe and able to exercise by unit HD Nephrologist
Key exclusion criteria (8 listed)
- regular vigorous exercise outside of hemodialysis
- over 79 years of age
- intradialytic exercise < 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 CyclingThe impact of interdialytic exercise on cardio protection during HD has never been studied. This approach may enhance cardiovascular benefits and overall physical fitness, thereby contributing to better health outcomes in individuals undergoing HD. | Other | 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 4
An echocardiogram will be completed pre-hemodialysis (HD) treatment and at peak hemodynamic stress (30 min before the end of HD treatment) at each of the four study sessions. Images will be captured in the left lateral position and standard apical 4, 2, and 3 chamber views will be recorded for analysis using automated speckle-tracking software (EchoPac, GE Healthcare)
7 secondary outcomes
Evaluate potential targets of preconditioning by exercise-induced cardio protection by focusing on hemodynamics (Blood Pressure)
Time frame: week 1 to week 4
Evaluate potential targets of preconditioning by exercise-induced cardio protection focusing on hemodynamics (CV Insight Monitoring),
Time frame: week 1 to week 4
Evaluate potential targets of preconditioning by exercise-induced cardioprotection, focusing on hemodynamics (Finapres)
Time frame: week 1 to week 4
Evaluate potential targets of preconditioning by exercise-induced cardio protection, focusing on blood markers
Time frame: week 1 to week 4
Evaluate potential targets of preconditioning by exercise-induced cardio protection, focusing on erythrocyte deformability
Time frame: week 1 to week 4
Evaluate potential targets of preconditioning by exercise-induced cardio protection, focusing on endothelial function
Time frame: week 1 to week 4
Evaluate potential targets of preconditioning by exercise-induced cardioprotection, focusing on proteomic analysis.
Time frame: week 1 to week 4
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 22 Jan 2025.
- 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.
Christopher McIntyre principal investigator
London Health Sciences Centre Research Institute
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 Hemodialysis 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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 22 Jan 2025. 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?
Contact Jarrin Penny, PhD, RN, CNeph (C) (519-685-8500 ext. 58765, jarrin.penny@lhsc.on.ca), or a site near the patient. 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 4). 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 22 Jan 2025.