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ClinicalTrials.gov ID

NCT05584605

Lead Sponsor

University of ZurichOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

40Estimated

Last Update Posted

Oct 18, 2022Actual

Start Date

Nov 2022Estimated

Primary Completion Date

Dec 2024Estimated

Completion Date

Dec 2024Estimated

Official Title

Changes in PERFusion and Cerebrovascular Reactivity Through Aerobic EXercise Training After Ischemic Stroke - a Proof of Concept Randomized Controlled Trial

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.

• Stroke, Ischemic

• Aerobic treadmill training
• Stretching exercise

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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 Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

University of ZurichOTHER

christoph.globas@usz.ch+41442555511