Perfusion Augmentation Through Exercise

NCT ID: NCT05584605

Last Updated: 2022-10-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-30
• Study Completion Date: 2024-12-31

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.

Conditions

Stroke, Ischemic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

aerobic treadmill training

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.

Group Type: EXPERIMENTAL

Aerobic treadmill training

Intervention Type: BEHAVIORAL

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 exercise

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.

Group Type: ACTIVE_COMPARATOR

Stretching exercise

Intervention Type: BEHAVIORAL

Interventions, such as stretching, relaxation, passive soft-tissue technics (excl. manipulation) that do not elevate the heart rate above 20HRR

Interventions

Aerobic treadmill training

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.

Intervention Type: BEHAVIORAL

Stretching exercise

Interventions, such as stretching, relaxation, passive soft-tissue technics (excl. manipulation) that do not elevate the heart rate above 20HRR

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christoph Globas, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital and University of Zurich

Locations

Ambulante Reha Triemli Zürich

Zurich, , Switzerland

Klinik Lengg AG

Zurich, , Switzerland

University Hospital Zurich

Zurich, , Switzerland

Countries

Switzerland

Central Contacts

Anne Schwarz, PhD

Role: CONTACT

anne.schwarz@usz.ch

+41442555645

Facility Contacts

Bartosz Bujan, MD

Role: primary

bartosz.bujan@kliniklengg.ch

+41443876767

Christoph Globas, MD

Role: primary

christoph.globas@usz.ch

+41442555511

Other Identifiers

2022-00438

Identifier Type: -

Identifier Source: org_study_id