Perfusion Augmentation Through Exercise (PERFEX)

University of Zurich (UZH)

Status: Not yet enrolling

Conditions: Stroke, Ischemic

Treatments: Behavioral: Stretching exercise; Behavioral: Aerobic treadmill training

Study type: Interventional

Funder types: Other

Identifiers

NCT05584605

2022-00438

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

aerobic treadmill training

Experimental group

Description:

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.

Treatment:

Behavioral: Aerobic treadmill training

stretching exercise

Active Comparator group

Description:

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.

Treatment:

Behavioral: Stretching exercise