Perfusion Augmentation Through Exercise

NCT05584605 | Unknown

• 1 other identifier: 2022-00438
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

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

Keywords

cerebral perfusion; aerobic exercise

Outcome Measures

Primary Outcomes (1)

• 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.

  post-intervention (12 weeks)

Secondary Outcomes (16)

• Brain imaging - intravoxel incoherent motion (IVIM)

  post-intervention (12 weeks)

• Brain imaging - NOVA-qMRI

  post-intervention (12 weeks)

• Brain imaging - Lesion volume

  post-intervention (12 weeks)

• Brain imaging - Collateral status

  post-intervention (12 weeks)

• Exercise stress testing

  post-intervention (12 weeks)

Other Outcomes (1)

• Concomitant medications

  post-intervention (12 weeks) + follow-up (+3 months)

Study Arms (2)

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.

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.

Behavioral: Stretching exercise

Interventions

Aerobic treadmill training 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.

aerobic treadmill training

Stretching exercise BEHAVIORAL

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

stretching exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (3)

Ambulante Reha Triemli Zürich

Zurich, Switzerland

Location

Klinik Lengg AG

Zurich, Switzerland

Location

University Hospital Zurich

Zurich, Switzerland

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Christoph Globas, MD

  University Hospital and University of Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne Schwarz, PhD

CONTACT

+41442555645; anne.schwarz@usz.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: October 18, 2022
• Study Start: November 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 18, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (3)