Clinical trial NCT05584605: Perfusion Augmentation Through Exercise
Official title: Changes in PERFusion and Cerebrovascular Reactivity Through Aerobic EXercise Training After Ischemic Stroke - a Proof of Concept Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke, Ischemic
Keywords: cerebral perfusion
aerobic exercise
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2022-10-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Brain imaging - cerebrovascular reactivity (CVR) by BOLD-fMRI
timeFrame: post-intervention (12 weeks)
Secondary outcomes:
measure: Brain imaging - intravoxel incoherent motion (IVIM)
timeFrame: post-intervention (12 weeks)
measure: Brain imaging - NOVA-qMRI
timeFrame: post-intervention (12 weeks)
measure: Brain imaging - Lesion volume
timeFrame: post-intervention (12 weeks)
measure: Brain imaging - Collateral status
timeFrame: post-intervention (12 weeks)
measure: Exercise stress testing
timeFrame: post-intervention (12 weeks)
measure: Six-Minute Walk Test (6MWT)
timeFrame: post-intervention (12 weeks) + follow-up (+3 months)
measure: Ten-Meter Walk Test (10MWT)
timeFrame: post-intervention (12 weeks) + follow-up (+3 months)
measure: Fugl-Meyer Assessment of the Lower Extremity (FMMA-LE)
timeFrame: post-intervention (12 weeks) + follow-up (+3 months)
measure: Motricity Index of the Lower Extremity (MI-LE)
timeFrame: post-intervention (12 weeks) + follow-up (+3 months)
measure: 5-Chair-Rise-Test
timeFrame: post-intervention (12 weeks) + follow-up (+3 months)
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: post-intervention (12 weeks) + follow-up (+3 months)
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: post-intervention (12 weeks) + follow-up (+3 months)
measure: Word list learning
timeFrame: post-intervention (12 weeks) + follow-up (+3 months)
measure: Digit Span Test / Corsi block
timeFrame: post-intervention (12 weeks) + follow-up (+3 months)
measure: Stroop test
timeFrame: post-intervention (12 weeks) + follow-up (+3 months)
measure: European Quality of Life 5 Dimensions 5 Level (5Q-5D-5L)
timeFrame: post-intervention (12 weeks) + follow-up (+3 months)
Other outcomes:
measure: Concomitant medications
timeFrame: post-intervention (12 weeks) + follow-up (+3 months)
Locations:
city: Zürich
country: Switzerland
facility: Ambulante Reha Triemli Zürich
city: Zürich
country: Switzerland
facility: Klinik Lengg AG
city: Zürich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: University Hospital and University of Zurich
name: Christoph Globas, MD
role: PRINCIPAL_INVESTIGATOR
References: