Stroke, IschemicPERFEXNCT05584605
Perfusion Augmentation Through Exercise
A study testing Aerobic treadmill training and Stretching exercise in people with Stroke, Ischemic, run by University of Zurich at 3 sites in Switzerland.
Trial summary
Large cerebral vessel occlusion is a common phenomenon in the general population and accounts for 13-35% of ischemic strokes. Chronic stenosis in the large cerebral arteries is associated with cerebral hypoperfusion, cognitive decline and an increased risk of stroke or recurrent stroke, respectively. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- Aerobic treadmill training and Stretching exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesSwitzerland
- Study dates
- Nov 2022to 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and Female patients of 18 years of age or above
- Subjects after ischemic cerebral stroke (≥ 3 months) due to large vessel occlusion
- Subjects do not qualify for flow augmentation through ECIC bypass or endovascular treatment
- Persistent deficit in BOLD-CVR
- Functional Ambulatory Categories >2
- Discharged from hospitalization / inpatient rehabilitation
- Living independent before stroke (mRS ≤3)
- Written Informed Consent
Who cannot join
- Severe cardiac disease, such as instable angina pectoris, pericarditis, heart failure (New York Health Association > II°), or hemodynamically significant valvular dysfunction
- Complete arterial stenosis
- Peripheral artery disease with mild to moderate claudication at < 200m or 200-1000m of walking
- Contra-indication, such as a history of a seizure, prior electroconvulsive therapy, deep brain stimulators or other metal in the head, skull defect, pacemaker, neuroleptic medication
- Inability to follow the procedures of the study, e.g., due to language problems (unable to follow to stage commands), psychological disorders (major depression), and / or a neurodegenerative disease (dementia)
- Known or suspected non-compliance, documented drug, or alcohol abuse
- Pregnancy
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites
Ambulante Reha Triemli Zürich
Zurich
Klinik Lengg AG
Zurich
Bartosz Bujan, MD, +41443876767, bartosz.bujan@kliniklengg.ch
University Hospital Zurich
Zurich
Christoph Globas, MD, +41442555511, christoph.globas@usz.ch
About this study
Official title: Changes in PERFusion and Cerebrovascular Reactivity Through Aerobic EXercise Training After Ischemic Stroke - a Proof of Concept Randomized Controlled Trial
Large cerebral vessel occlusion is a common phenomenon in the general population and accounts for 13-35% of ischemic strokes. Chronic stenosis in the large cerebral arteries is associated with cerebral hypoperfusion, cognitive decline and an increased risk of stroke or recurrent stroke, respectively.
Even with upgrowth of surgical or endovascular interventions, mechanical reopening of the occluded vessels is often not possible. Alternative treatment opportunities include minimal-to-moderate blood pressure elevation (typically by ceasing antihypertensives) waiting for collateral circulation to develop spontaneously. Another conservative approach to increase cerebral perfusion is aerobic exercising. Physical activity has shown to lead to cerebral blood flow increase, especially in activated brain areas of healthy human and rat models. However, it is remains unknown, how physiological adaptation to physical activity expresses in persons after stroke due to large vessel occlusion. Herein, it is hypothesized that aerobic exercise facilitates the development of an extensive and functional vascular collateral network in persons with ischemic stroke and perfusion compromise.
- Conditions
- Stroke, Ischemic
- Being tested
- Aerobic treadmill training, Stretching exercise
- Keywords
- cerebral perfusion, aerobic exercise
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic treadmill trainingBehavioural
The intervention will be delivered based on the initial exercise testing and graded based by increasing the duration, speed and/or altitude of the treadmill training.
Stretching exerciseBehavioural
Interventions, such as stretching, relaxation, passive soft-tissue technics (excl. manipulation) that do not elevate the heart rate above 20HRR
| Study group | Role | What they receive |
|---|---|---|
| aerobic treadmill training | Experimental | Progressive graded, high-intensity aerobic treadmill training is delivered over 36 sessions at a frequency of 3x per week for 30-50 minutes of training per session over a period of 3 months. If possible, the training intensity is progressed from 40% to 80% of heart rate reserve, according to the supervising therapist. Receives: Behavioral: Aerobic treadmill training |
| stretching exercise | Active comparator | The control intervention includes stretching exercise therapy similarly heart rate controlled within limits up to 20% of heart rate reserve over 36 sessions at a frequency of 3x per week for 30 minutes. Receives: Behavioral: Stretching exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain imaging - cerebrovascular reactivity (CVR) by BOLD-fMRI
Functional brain tissue perfusion and tissue at risk based on cerebrovascular reactivity by blood oxygenation-level dependent functional magnetic resonance imaging (BOLD-fMRI), measured as the percentage BOLD signal change /mmHg CO2.
Measured: post-intervention (12 weeks)
Secondary outcomes (16)
Brain imaging - intravoxel incoherent motion (IVIM)
Functionality of brain microvasculature by measuring diffusion and perfusion components of tissue based on intravoxel incoherent motion
Measured: post-intervention (12 weeks)
Brain imaging - NOVA-qMRI
Blood flow velocity based on non-invasive optimal vessel analysis quantitative magnetic resonance imaging
Measured: post-intervention (12 weeks)
Brain imaging - Lesion volume
based on 3D T1 weighted imaging, 3D Fluid-Attenuated Inversion Recovery (FLAIR), Diffusion-Eighted Imaging (DWI)
Measured: post-intervention (12 weeks)
Brain imaging - Collateral status
Collateral status based on 3D time of flight angiography (TOF)
Measured: post-intervention (12 weeks)
Exercise stress testing
Cycle ergometer testing with spirometry
Measured: post-intervention (12 weeks)
Six-Minute Walk Test (6MWT)
Functional walking capacity in meters
Measured: post-intervention (12 weeks) + follow-up (+3 months)
Ten-Meter Walk Test (10MWT)
Walking speed in m/s
Measured: post-intervention (12 weeks) + follow-up (+3 months)
Fugl-Meyer Assessment of the Lower Extremity (FMMA-LE)
Stroke-specific motor impairment index to assess lower limb motor function with a total score ranging from 0 to 34 and higher scores indicating better performance.
Measured: post-intervention (12 weeks) + follow-up (+3 months)
Motricity Index of the Lower Extremity (MI-LE)
Muscle strength assessment of three major muscle groups of the lower extremity with a total score ranging from 0 to 100 and higher scores indicating better performance.
Measured: post-intervention (12 weeks) + follow-up (+3 months)
5-Chair-Rise-Test
Functional muscle strength, measured in seconds to complete the task.
Measured: post-intervention (12 weeks) + follow-up (+3 months)
International Physical Activity Questionnaire (IPAQ)
self-reported physical activity
Measured: post-intervention (12 weeks) + follow-up (+3 months)
Montreal Cognitive Assessment (MoCA)
Screening assessment of cognitive functions with a maximum score of 30 points.
Measured: post-intervention (12 weeks) + follow-up (+3 months)
Word list learning
Assessment of memory function
Measured: post-intervention (12 weeks) + follow-up (+3 months)
Digit Span Test / Corsi block
Assessment verbal and nonverbal working memory
Measured: post-intervention (12 weeks) + follow-up (+3 months)
Stroop test
Assessment of executive function and inhibition
Measured: post-intervention (12 weeks) + follow-up (+3 months)
European Quality of Life 5 Dimensions 5 Level (5Q-5D-5L)
Quality of life questionnaire that assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) on a 5-level scale ranging from 1 - no, 2 - slight, 3 - moderate, 4 - severe to 5 - extreme problems or unstable to.
Measured: post-intervention (12 weeks) + follow-up (+3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study startNov 2022 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoph Globas, MD, Principal investigator, University Hospital and University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05584605
- Sponsor's protocol ID
- 2022-00438
- Acronym
- PERFEX
- Status last verified
- Oct 2022
- First submitted
- 15 Sep 2022
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in PERFusion and Cerebrovascular Reactivity Through Aerobic EXercise Training After Ischemic Stroke - a Proof of Concept Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05584605
- Acronym / sponsor ID
- PERFEX / 2022-00438
- Conditions
- Stroke, Ischemic
- Keywords
- cerebral perfusion, aerobic exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Nov 2022 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 18 Oct 2022 (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.
Large cerebral vessel occlusion is a common phenomenon in the general population and accounts for 13-35% of ischemic strokes. Chronic stenosis in the large cerebral arteries is associated with cerebral hypoperfusion, cognitive decline and an increased risk of stroke or recurrent stroke, respectively.
Even with upgrowth of surgical or endovascular interventions, mechanical reopening of the occluded vessels is often not possible. Alternative treatment opportunities include minimal-to-moderate blood pressure elevation (typically by ceasing antihypertensives) waiting for collateral circulation to develop spontaneously. Another conservative approach to increase cerebral perfusion is aerobic exercising. Physical activity has shown to lead to cerebral blood flow increase, especially in activated brain areas of healthy human and rat models. However, it is remains unknown, how physiological adaptation to physical activity expresses in persons after stroke due to large vessel occlusion. Herein, it is hypothesized that aerobic exercise facilitates the development of an extensive and functional vascular collateral network in persons with ischemic stroke and perfusion compromise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aerobic treadmill training | Experimental | Behavioral: Aerobic treadmill trainingProgressive graded, high-intensity aerobic treadmill training is delivered over 36 sessions at a frequency of 3x per week for 30-50 minutes of training per session over a period of 3 months. If possible, the training intensity is progressed from 40% to 80% of heart rate reserve, according to the supervising therapist. |
| stretching exercise | Active comparator | Behavioral: Stretching exerciseThe control intervention includes stretching exercise therapy similarly heart rate controlled within limits up to 20% of heart rate reserve over 36 sessions at a frequency of 3x per week for 30 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and Female patients of 18 years of age or above
- Subjects after ischemic cerebral stroke (≥ 3 months) due to large vessel occlusion
- Subjects do not qualify for flow augmentation through ECIC bypass or endovascular treatment
- Persistent deficit in BOLD-CVR
- Functional Ambulatory Categories >2
Key exclusion criteria (7 listed)
- Severe cardiac disease, such as instable angina pectoris, pericarditis, heart failure (New York Health Association > II°), or hemodynamically significant valvular dysfunction
- Complete arterial stenosis
- Peripheral artery disease with mild to moderate claudication at < 200m or 200-1000m of walking
- Contra-indication, such as a history of a seizure, prior electroconvulsive therapy, deep brain stimulators or other metal in the head, skull defect, pacemaker, neuroleptic medication
- Inability to follow the procedures of the study, e.g., due to language problems (unable to follow to stage commands), psychological disorders (major depression), and / or a neurodegenerative disease (dementia)
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 |
|---|---|---|
| Aerobic treadmill trainingThe intervention will be delivered based on the initial exercise testing and graded based by increasing the duration, speed and/or altitude of the treadmill training. | Behavioural | aerobic treadmill training |
| Stretching exerciseInterventions, such as stretching, relaxation, passive soft-tissue technics (excl. manipulation) that do not elevate the heart rate above 20HRR | Behavioural | stretching exercise |
Primary outcome
Brain imaging - cerebrovascular reactivity (CVR) by BOLD-fMRI
Time frame: post-intervention (12 weeks)
Functional brain tissue perfusion and tissue at risk based on cerebrovascular reactivity by blood oxygenation-level dependent functional magnetic resonance imaging (BOLD-fMRI), measured as the percentage BOLD signal change /mmHg CO2.
16 secondary outcomes
Brain imaging - intravoxel incoherent motion (IVIM)
Time frame: post-intervention (12 weeks)
Brain imaging - NOVA-qMRI
Time frame: post-intervention (12 weeks)
Brain imaging - Lesion volume
Time frame: post-intervention (12 weeks)
Brain imaging - Collateral status
Time frame: post-intervention (12 weeks)
Exercise stress testing
Time frame: post-intervention (12 weeks)
Six-Minute Walk Test (6MWT)
Time frame: post-intervention (12 weeks) + follow-up (+3 months)
Ten-Meter Walk Test (10MWT)
Time frame: post-intervention (12 weeks) + follow-up (+3 months)
Fugl-Meyer Assessment of the Lower Extremity (FMMA-LE)
Time frame: post-intervention (12 weeks) + follow-up (+3 months)
Motricity Index of the Lower Extremity (MI-LE)
Time frame: post-intervention (12 weeks) + follow-up (+3 months)
5-Chair-Rise-Test
Time frame: post-intervention (12 weeks) + follow-up (+3 months)
International Physical Activity Questionnaire (IPAQ)
Time frame: post-intervention (12 weeks) + follow-up (+3 months)
Montreal Cognitive Assessment (MoCA)
Time frame: post-intervention (12 weeks) + follow-up (+3 months)
Word list learning
Time frame: post-intervention (12 weeks) + follow-up (+3 months)
Digit Span Test / Corsi block
Time frame: post-intervention (12 weeks) + follow-up (+3 months)
Stroop test
Time frame: post-intervention (12 weeks) + follow-up (+3 months)
European Quality of Life 5 Dimensions 5 Level (5Q-5D-5L)
Time frame: post-intervention (12 weeks) + follow-up (+3 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Individual participant dataSharing planned: No
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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.
Christoph Globas, MD principal investigator
University Hospital and University of Zurich
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic treadmill training and Stretching exercise in people with Stroke, Ischemic, run by University of Zurich at 3 sites in Switzerland.
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 7 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 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. 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 Anne Schwarz, PhD (+41442555645, anne.schwarz@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain imaging - cerebrovascular reactivity (CVR) by BOLD-fMRI (time frame: post-intervention (12 weeks)). 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 18 Oct 2022.