StrokeNCT03614585
Exercise Intensity Matters in Stroke Rehabilitation
A study testing 12 weeks of High-intensity Interval Training and 12 weeks of Moderate-Intensity Continuous Training in people with Stroke, run by McGill University at 2 sites in Canada.
Trial summary
The main objective of this multi-site project is to compare the effects of 12 weeks of HIIT vs. MICT on brain plasticity. The effects of HIIT vs. MICT on cardiovascular health, psychosocial predictors of physical activity and motor function will also be compared. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- 12 weeks of High-intensity Interval Training and 12 weeks of Moderate-Intensity Continuous Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Jan 2020to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 6-60 months following first-ever, single stroke confirmed by MRI/CT
- Living in the community and able to independently walk at least 10 meters (assistive devices permitted, as this is representative of many people who regain some walking ability following stroke but commonly with some adaptation)
- Montreal Cognitive Assessment score >20 (individuals with this score are capable to follow exercise instructions)
Who cannot join
- Significant disability as determined by modified Rankin scale score <2
- Stroke of non-cardiogenic origin or tumor
- Actively engaged in stroke rehabilitation services or a structured exercise program besides the one provided in the study
- Class C or D American Heart Association Risk Criteria
- Other neurological or musculoskeletal co-morbidities that preclude exercise participation
- Pain which is worsened with exercise
- Cognitive, communication, or behavioral issues that would limit safe exercise participation
- Contraindications to transcranial magnetic stimulation.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
Ontario Central South Stroke Network
Hamilton, Ontario, L8L 2X2
Ada Tang, PhD, 905-525-9140 ext. 27818, atang@mcmaster.ca
Jennifer Crozier, MSc, croziej@mcmaster.ca
- Recruiting
Jewish Rehabiliation Hospital
Laval, Quebec, H7V 1R2
Marc Roig, PhD, 450-688-9550 ext. 4677, marc.roigpull@mcgill.ca
Jean-Francois Nepveu, MSc, 450-688-9550 ext. 4217
About this study
Official title: Exercise Intensity Matters: An Opportunity to Promote Neurorecovery and Cardiovascular Health in Stroke
The main objective of this multi-site project is to compare the effects of 12 weeks of HIIT vs. MICT on brain plasticity. The effects of HIIT vs. MICT on cardiovascular health, psychosocial predictors of physical activity and motor function will also be compared. HIIT and MICT will be delivered through a whole-body exercise paradigm using a recumbent stepper that requires arm and leg forces. Outcomes will be assessed at baseline (T0, 0 weeks), at the end of the intervention (T1, 12 weeks) and at 8-week follow-up (T2, 20 weeks).
Read the detailed description
Background: Stroke is a major health issue in Canada, with 405,000 Canadians currently living with stroke. Exercise is an important component of stroke rehabilitation that can result in improved function and health. Traditionally, exercise rehabilitation programs for stroke employ moderate-intensity continuous training (MICT) protocols that are typically sustained for 20-30 minutes. The continuous nature of this form of training however, even at moderate intensities, is challenging for many individuals with stroke to sustain due to neuromotor impairments and poor exercise capacity. High-intensity exercise, when delivered in short interval bursts (i.e. high-intensity interval training, HIIT), may be a feasible alternative that allows higher intensities to be achieved during exercise. This is important because intensity of training is the critical factor in promoting changes in neuroplasticity and cardiovascular health, the two most important aspects of recovery and secondary prevention after stroke. Interventions implemented earlier following stroke are generally viewed to yield greater benefits, but high intensity exercise may also promote neuroplasticity and optimize cardiovascular health in later stages of recovery. Furthermore, determining if HIIT is viewed to be motivating and enjoyable for individuals post-stroke can provide insight into the sustainability of this intervention.
Objective: To compare the effects of 12 weeks of HIIT and MICT on neuroplasticity, cardiovascular health and psychosocial predictors of physical activity in individuals with chronic stroke.
Design: Participants will be recruited from two research sites and randomly allocated into HIIT or MICT. Participants will be assessed before and after the training period, and at an 8-week follow-up.
Outcomes: 1) The investigators will assess: Neuroplasticity: by measuring markers of corticospinal excitability at rest and in response to a non-invasive brain stimulation protocol applied over the primary motor cortex (M1); 2) Cardiovascular health: by measuring cardiorespiratory fitness, resting blood pressure, arterial stiffness, and waist-hip ratio; 3) Psychosocial predictors of physical activity: by measuring exercise motivation and enjoyment.
Methods: Neuroplasticity: motor evoked potentials amplitude, intracortical facilitation and short-intracortical inhibition on the lesioned and unlesioned upper limb M1 area at rest and in response to continuous theta-burst will be measured with transcranial magnetic stimulation; Cardiovascular health: cardiorespiratory fitness will be measured with a graded exercise test, resting blood pressure with an automated blood pressure monitor and arterial stiffness using applanation tonometry. Exercise motivation and enjoyment will be assessed with the Physical Activity Enjoyment Scale and the Behavioral Regulation Exercise Questionnaire-3, respectively.
Expected results: Both HIIT and MICT will result in improvements in outcomes of neuroplasticity and cardiovascular health. However, improvements with HIIT will be greater and will last longer. Participants will rate HIIT as enjoyable as MICT, and motivation for exercise will increase similarly after both interventions.
Impact: HIIT is a promising, time-efficient, and potentially more effective alternative to traditional MICT protocols that could offer an opportunity for greater improvement in motor recovery and cardiovascular health in people living with stroke.
- Conditions
- Stroke
- Being tested
- 12 weeks of High-intensity Interval Training, 12 weeks of Moderate-Intensity Continuous Training
- Keywords
- Stroke, Rehabilitation, Neurosciences, Exercise, Neurorecovery, Cardiovascular health, High-intensity interval training, Moderate-intensity continuous training
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12 weeks of High-intensity Interval TrainingBehavioural
Cardiovascular exercise
12 weeks of Moderate-Intensity Continuous TrainingBehavioural
Cardiovascular exercise
| Study group | Role | What they receive |
|---|---|---|
| High-intensity interval training | Experimental | Intensity will be determined using a combination of heart rate reserve (HRR, calculated as HRR= [max HR - resting HR] x [% training] + [resting HR]) and ratings of perceived exertion (RPE). The protocol will involve 10 60-second intervals of high intensity interspersed with 9 60-second low-intensity intervals. The initial high intensity intervals will start at 80% of the HRR (RPE=14-17) and progress by 10% every 4 weeks. Low intensity intervals will be performed at 30% of HRR (RPE=9-11). Three-minute warm-up and 2-minute cool-down periods will be performed at 30% of HRR. Total HIIT time including warm-up and cool-down is 24 minutes. Receives: Behavioral: 12 weeks of High-intensity Interval Training |
| Moderate-intensity continuous training | Experimental | Intensity will be determined using a combination of heart rate reserve (HRR, calculated as HRR= [max HR - resting HR] x [% training] + [resting HR]) and ratings of perceived exertion (RPE). The MICT protocol will be increased using a progression schedule previously used (initial intensity at 40% HRR (RPE=9-11), and progressed by 10% HRR every 4 weeks up to 60% HRR (RPE=13-14) will be maintained until the end of the intervention). A 3-minute warm-up and 2-minute cool-down will be performed at 30% HRR (RPE=9-11). The total duration of MICT, including warm-up and cool-down, will be 35 minutes. Receives: Behavioral: 12 weeks of Moderate-Intensity Continuous Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortico-spinal excitability
Single pulse of transcranial magnetic stimulation protocol.
Measured: 12 weeks
Secondary outcomes (7)
Intra-cortical inhibition
Paired-pulse of transcranial magnetic stimulation protocol.
Measured: 12 weeks
Intra-cortical facilitation
Paired-pulse of transcranial magnetic stimulation protocol.
Measured: 12 weeks
Systolic resting blood pressure
Supine resting blood pressure.
Measured: 12 weeks
Diastolic resting blood pressure
Supine resting blood pressure.
Measured: 12 weeks
Arterial stiffness
Central pulse wave velocity.
Measured: 12 weeks
Cardiorespiratory fitness
Maximum rate of oxygen consumption measured during maximum physical effort.
Measured: 12 weeks
Waist-hip ratio
Ratio of waist circumference measured at the level of the umbilicus, and hip circumference taken at the level of the greater trochanters.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start1 Jan 2020
- Primary completionSep 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University, Jewish Rehabilitation Hospital, Ontario Stroke Network, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Marc Roig, McGill University
- Investigators
- Marc Roig, PhD, Principal investigator, McGill UniversityAda Tang, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03614585
- Sponsor's protocol ID
- 388320
- Status last verified
- Oct 2023
- First submitted
- 26 Jul 2018
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Results will be publish in peer-review journals.
Publications
Rodrigues L, Moncion K, De Las Heras B, Cristini J, Khalili R, Eng JJ, Fung J, MacKay-Lyons M, Thiel A, Tang A, Roig M. Modulating Brain Excitability with Cardiovascular Exercise in Chronic Stroke: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2025 Oct;39(10):801-813. doi: 10.1177/15459683251351883. Epub 2025 Jul 10.
PubMed 40637167Rodrigues L, Moncion K, Angelopoulos SA, Heras BL, Sweet S, Eng JJ, Fung J, MacKay-Lyons M, Tang A, Roig M. Psychosocial Responses to a Cardiovascular Exercise Randomized Controlled Trial: Does Intensity Matter for Individuals Post-stroke? Arch Phys Med Rehabil. 2025 Jun;106(6):828-836. doi: 10.1016/j.apmr.2025.01.468. Epub 2025 Jan 31.
PubMed 39894292Moncion K, Rodrigues L, De Las Heras B, Noguchi KS, Wiley E, Eng JJ, MacKay-Lyons M, Sweet SN, Thiel A, Fung J, Stratford P, Richardson JA, MacDonald MJ, Roig M, Tang A. Cardiorespiratory Fitness Benefits of High-Intensity Interval Training After Stroke: A Randomized Controlled Trial. Stroke. 2024 Sep;55(9):2202-2211. doi: 10.1161/STROKEAHA.124.046564. Epub 2024 Aug 7.
PubMed 39113181Rodrigues L, Moncion K, Eng JJ, Noguchi KS, Wiley E, de Las Heras B, Sweet SN, Fung J, MacKay-Lyons M, Nelson AJ, Medeiros D, Crozier J, Thiel A, Tang A, Roig M. Intensity matters: protocol for a randomized controlled trial exercise intervention for individuals with chronic stroke. Trials. 2022 May 24;23(1):442. doi: 10.1186/s13063-022-06359-w.
PubMed 35610659
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Intensity Matters: An Opportunity to Promote Neurorecovery and Cardiovascular Health in Stroke
- ClinicalTrials.gov ID
- NCT03614585
- Acronym / sponsor ID
- 388320
- Conditions
- Stroke
- Keywords
- Stroke, Rehabilitation, Neurosciences, Exercise, Neurorecovery, Cardiovascular health, High-intensity interval training, Moderate-intensity continuous training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- McMaster University, Jewish Rehabilitation Hospital, Ontario Stroke Network, Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 3 Aug 2018 (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 main objective of this multi-site project is to compare the effects of 12 weeks of HIIT vs. MICT on brain plasticity. The effects of HIIT vs. MICT on cardiovascular health, psychosocial predictors of physical activity and motor function will also be compared. HIIT and MICT will be delivered through a whole-body exercise paradigm using a recumbent stepper that requires arm and leg forces. Outcomes will be assessed at baseline (T0, 0 weeks), at the end of the intervention (T1, 12 weeks) and at 8-week follow-up (T2, 20 weeks).
Detailed description
Background: Stroke is a major health issue in Canada, with 405,000 Canadians currently living with stroke. Exercise is an important component of stroke rehabilitation that can result in improved function and health. Traditionally, exercise rehabilitation programs for stroke employ moderate-intensity continuous training (MICT) protocols that are typically sustained for 20-30 minutes. The continuous nature of this form of training however, even at moderate intensities, is challenging for many individuals with stroke to sustain due to neuromotor impairments and poor exercise capacity. High-intensity exercise, when delivered in short interval bursts (i.e. high-intensity interval training, HIIT), may be a feasible alternative that allows higher intensities to be achieved during exercise. This is important because intensity of training is the critical factor in promoting changes in neuroplasticity and cardiovascular health, the two most important aspects of recovery and secondary prevention after stroke. Interventions implemented earlier following stroke are generally viewed to yield greater benefits, but high intensity exercise may also promote neuroplasticity and optimize cardiovascular health in later stages of recovery. Furthermore, determining if HIIT is viewed to be motivating and enjoyable for individuals post-stroke can provide insight into the sustainability of this intervention.
Objective: To compare the effects of 12 weeks of HIIT and MICT on neuroplasticity, cardiovascular health and psychosocial predictors of physical activity in individuals with chronic stroke.
Design: Participants will be recruited from two research sites and randomly allocated into HIIT or MICT. Participants will be assessed before and after the training period, and at an 8-week follow-up.
Outcomes: 1) The investigators will assess: Neuroplasticity: by measuring markers of corticospinal excitability at rest and in response to a non-invasive brain stimulation protocol applied over the primary motor cortex (M1); 2) Cardiovascular health: by measuring cardiorespiratory fitness, resting blood pressure, arterial stiffness, and waist-hip ratio; 3) Psychosocial predictors of physical activity: by measuring exercise motivation and enjoyment.
Methods: Neuroplasticity: motor evoked potentials amplitude, intracortical facilitation and short-intracortical inhibition on the lesioned and unlesioned upper limb M1 area at rest and in response to continuous theta-burst will be measured with transcranial magnetic stimulation; Cardiovascular health: cardiorespiratory fitness will be measured with a graded exercise test, resting blood pressure with an automated blood pressure monitor and arterial stiffness using applanation tonometry. Exercise motivation and enjoyment will be assessed with the Physical Activity Enjoyment Scale and the Behavioral Regulation Exercise Questionnaire-3, respectively.
Expected results: Both HIIT and MICT will result in improvements in outcomes of neuroplasticity and cardiovascular health. However, improvements with HIIT will be greater and will last longer. Participants will rate HIIT as enjoyable as MICT, and motivation for exercise will increase similarly after both interventions.
Impact: HIIT is a promising, time-efficient, and potentially more effective alternative to traditional MICT protocols that could offer an opportunity for greater improvement in motor recovery and cardiovascular health in people living with stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-intensity interval training | Experimental | Behavioral: 12 weeks of High-intensity Interval TrainingIntensity will be determined using a combination of heart rate reserve (HRR, calculated as HRR= [max HR - resting HR] x [% training] + [resting HR]) and ratings of perceived exertion (RPE). The protocol will involve 10 60-second intervals of high intensity interspersed with 9 60-second low-intensity intervals. The initial high intensity intervals will start at 80% of the HRR (RPE=14-17) and progress by 10% every 4 weeks. Low intensity intervals will be performed at 30% of HRR (RPE=9-11). Three-minute warm-up and 2-minute cool-down periods will be performed at 30% of HRR. Total HIIT time including warm-up and cool-down is 24 minutes. |
| Moderate-intensity continuous training | Experimental | Behavioral: 12 weeks of Moderate-Intensity Continuous TrainingIntensity will be determined using a combination of heart rate reserve (HRR, calculated as HRR= [max HR - resting HR] x [% training] + [resting HR]) and ratings of perceived exertion (RPE). The MICT protocol will be increased using a progression schedule previously used (initial intensity at 40% HRR (RPE=9-11), and progressed by 10% HRR every 4 weeks up to 60% HRR (RPE=13-14) will be maintained until the end of the intervention). A 3-minute warm-up and 2-minute cool-down will be performed at 30% HRR (RPE=9-11). The total duration of MICT, including warm-up and cool-down, will be 35 minutes. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 6-60 months following first-ever, single stroke confirmed by MRI/CT
- Living in the community and able to independently walk at least 10 meters (assistive devices permitted, as this is representative of many people who regain some walking ability following stroke but commonly with some adaptation)
- Montreal Cognitive Assessment score >20 (individuals with this score are capable to follow exercise instructions)
Key exclusion criteria (8 listed)
- Significant disability as determined by modified Rankin scale score <2
- Stroke of non-cardiogenic origin or tumor
- Actively engaged in stroke rehabilitation services or a structured exercise program besides the one provided in the study
- Class C or D American Heart Association Risk Criteria
- Other neurological or musculoskeletal co-morbidities that preclude exercise participation
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 |
|---|---|---|
| 12 weeks of High-intensity Interval TrainingCardiovascular exercise | Behavioural | High-intensity interval training |
| 12 weeks of Moderate-Intensity Continuous TrainingCardiovascular exercise | Behavioural | Moderate-intensity continuous training |
Primary outcome
Cortico-spinal excitability
Time frame: 12 weeks
Single pulse of transcranial magnetic stimulation protocol.
7 secondary outcomes
Intra-cortical inhibition
Time frame: 12 weeks
Intra-cortical facilitation
Time frame: 12 weeks
Systolic resting blood pressure
Time frame: 12 weeks
Diastolic resting blood pressure
Time frame: 12 weeks
Arterial stiffness
Time frame: 12 weeks
Cardiorespiratory fitness
Time frame: 12 weeks
Waist-hip ratio
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Derived from this study: PubMed 40637167Rodrigues L, Moncion K, De Las Heras B, Cristini J, Khalili R, Eng JJ, Fung J, MacKay-Lyons M, Thiel A, Tang A, Roig M. Modulating Brain Excitability with Cardiovascular Exercise in Chronic Stroke: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2025 Oct;39(10):801-813. doi: 10.1177/15459683251351883. Epub 2025 Jul 10.
- Derived from this study: PubMed 39894292Rodrigues L, Moncion K, Angelopoulos SA, Heras BL, Sweet S, Eng JJ, Fung J, MacKay-Lyons M, Tang A, Roig M. Psychosocial Responses to a Cardiovascular Exercise Randomized Controlled Trial: Does Intensity Matter for Individuals Post-stroke? Arch Phys Med Rehabil. 2025 Jun;106(6):828-836. doi: 10.1016/j.apmr.2025.01.468. Epub 2025 Jan 31.
- Derived from this study: PubMed 39113181Moncion K, Rodrigues L, De Las Heras B, Noguchi KS, Wiley E, Eng JJ, MacKay-Lyons M, Sweet SN, Thiel A, Fung J, Stratford P, Richardson JA, MacDonald MJ, Roig M, Tang A. Cardiorespiratory Fitness Benefits of High-Intensity Interval Training After Stroke: A Randomized Controlled Trial. Stroke. 2024 Sep;55(9):2202-2211. doi: 10.1161/STROKEAHA.124.046564. Epub 2024 Aug 7.
- Derived from this study: PubMed 35610659Rodrigues L, Moncion K, Eng JJ, Noguchi KS, Wiley E, de Las Heras B, Sweet SN, Fung J, MacKay-Lyons M, Nelson AJ, Medeiros D, Crozier J, Thiel A, Tang A, Roig M. Intensity matters: protocol for a randomized controlled trial exercise intervention for individuals with chronic stroke. Trials. 2022 May 24;23(1):442. doi: 10.1186/s13063-022-06359-w.
- Individual participant dataSharing planned: No. Results will be publish in peer-review journals.
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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.
Marc Roig, PhD principal investigator
McGill University
Ada Tang, PhD principal investigator
McMaster University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12 weeks of High-intensity Interval Training and 12 weeks of Moderate-Intensity Continuous Training in people with Stroke, run by McGill University at 2 sites 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 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: status not confirmed, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marc Roig, PhD (514-398-4400 ext. 00841, marc.roigpull@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cortico-spinal excitability (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03614585, which also lists 4 linked publications.
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 19 Oct 2023; AzTrials last refreshed its copy on 1 Nov 2026.