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Perfusion Augmentation Through Exercise (PERFEX)

Primary Purpose

Stroke, Ischemic

Status
Not yet recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Aerobic treadmill training
Stretching exercise
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Ischemic focused on measuring cerebral perfusion, aerobic exercise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Ambulante Reha Triemli Zürich
  • Klinik Lengg AG
  • University Hospital Zurich

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

aerobic treadmill training

stretching exercise

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Brain imaging - intravoxel incoherent motion (IVIM)
Functionality of brain microvasculature by measuring diffusion and perfusion components of tissue based on intravoxel incoherent motion
Brain imaging - NOVA-qMRI
Blood flow velocity based on non-invasive optimal vessel analysis quantitative magnetic resonance imaging
Brain imaging - Lesion volume
based on 3D T1 weighted imaging, 3D Fluid-Attenuated Inversion Recovery (FLAIR), Diffusion-Eighted Imaging (DWI)
Brain imaging - Collateral status
Collateral status based on 3D time of flight angiography (TOF)
Exercise stress testing
Cycle ergometer testing with spirometry
Six-Minute Walk Test (6MWT)
Functional walking capacity in meters
Ten-Meter Walk Test (10MWT)
Walking speed in m/s
Fugl-Meyer Assessment of the Lower Extremity (FMMA-LE)
Stroke-specific motor impairment index to assess lower limb motor function with a total score ranging from 0 to 34 and higher scores indicating better performance.
Motricity Index of the Lower Extremity (MI-LE)
Muscle strength assessment of three major muscle groups of the lower extremity with a total score ranging from 0 to 100 and higher scores indicating better performance.
5-Chair-Rise-Test
Functional muscle strength, measured in seconds to complete the task.
International Physical Activity Questionnaire (IPAQ)
self-reported physical activity
Montreal Cognitive Assessment (MoCA)
Screening assessment of cognitive functions with a maximum score of 30 points.
Word list learning
Assessment of memory function
Digit Span Test / Corsi block
Assessment verbal and nonverbal working memory
Stroop test
Assessment of executive function and inhibition
European Quality of Life 5 Dimensions 5 Level (5Q-5D-5L)
Quality of life questionnaire that assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) on a 5-level scale ranging from 1 - no, 2 - slight, 3 - moderate, 4 - severe to 5 - extreme problems or unstable to.

Full Information

First Posted
September 15, 2022
Last Updated
October 13, 2022
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT05584605
Brief Title
Perfusion Augmentation Through Exercise
Acronym
PERFEX
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2022 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic
Keywords
cerebral perfusion, aerobic exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
aerobic treadmill training
Arm Type
Experimental
Arm 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.
Arm Title
stretching exercise
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Aerobic treadmill training
Intervention Description
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
Intervention Name(s)
Stretching exercise
Intervention Description
Interventions, such as stretching, relaxation, passive soft-tissue technics (excl. manipulation) that do not elevate the heart rate above 20HRR
Primary Outcome Measure Information:
Title
Brain imaging - cerebrovascular reactivity (CVR) by BOLD-fMRI
Description
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.
Time Frame
post-intervention (12 weeks)
Secondary Outcome Measure Information:
Title
Brain imaging - intravoxel incoherent motion (IVIM)
Description
Functionality of brain microvasculature by measuring diffusion and perfusion components of tissue based on intravoxel incoherent motion
Time Frame
post-intervention (12 weeks)
Title
Brain imaging - NOVA-qMRI
Description
Blood flow velocity based on non-invasive optimal vessel analysis quantitative magnetic resonance imaging
Time Frame
post-intervention (12 weeks)
Title
Brain imaging - Lesion volume
Description
based on 3D T1 weighted imaging, 3D Fluid-Attenuated Inversion Recovery (FLAIR), Diffusion-Eighted Imaging (DWI)
Time Frame
post-intervention (12 weeks)
Title
Brain imaging - Collateral status
Description
Collateral status based on 3D time of flight angiography (TOF)
Time Frame
post-intervention (12 weeks)
Title
Exercise stress testing
Description
Cycle ergometer testing with spirometry
Time Frame
post-intervention (12 weeks)
Title
Six-Minute Walk Test (6MWT)
Description
Functional walking capacity in meters
Time Frame
post-intervention (12 weeks) + follow-up (+3 months)
Title
Ten-Meter Walk Test (10MWT)
Description
Walking speed in m/s
Time Frame
post-intervention (12 weeks) + follow-up (+3 months)
Title
Fugl-Meyer Assessment of the Lower Extremity (FMMA-LE)
Description
Stroke-specific motor impairment index to assess lower limb motor function with a total score ranging from 0 to 34 and higher scores indicating better performance.
Time Frame
post-intervention (12 weeks) + follow-up (+3 months)
Title
Motricity Index of the Lower Extremity (MI-LE)
Description
Muscle strength assessment of three major muscle groups of the lower extremity with a total score ranging from 0 to 100 and higher scores indicating better performance.
Time Frame
post-intervention (12 weeks) + follow-up (+3 months)
Title
5-Chair-Rise-Test
Description
Functional muscle strength, measured in seconds to complete the task.
Time Frame
post-intervention (12 weeks) + follow-up (+3 months)
Title
International Physical Activity Questionnaire (IPAQ)
Description
self-reported physical activity
Time Frame
post-intervention (12 weeks) + follow-up (+3 months)
Title
Montreal Cognitive Assessment (MoCA)
Description
Screening assessment of cognitive functions with a maximum score of 30 points.
Time Frame
post-intervention (12 weeks) + follow-up (+3 months)
Title
Word list learning
Description
Assessment of memory function
Time Frame
post-intervention (12 weeks) + follow-up (+3 months)
Title
Digit Span Test / Corsi block
Description
Assessment verbal and nonverbal working memory
Time Frame
post-intervention (12 weeks) + follow-up (+3 months)
Title
Stroop test
Description
Assessment of executive function and inhibition
Time Frame
post-intervention (12 weeks) + follow-up (+3 months)
Title
European Quality of Life 5 Dimensions 5 Level (5Q-5D-5L)
Description
Quality of life questionnaire that assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) on a 5-level scale ranging from 1 - no, 2 - slight, 3 - moderate, 4 - severe to 5 - extreme problems or unstable to.
Time Frame
post-intervention (12 weeks) + follow-up (+3 months)
Other Pre-specified Outcome Measures:
Title
Concomitant medications
Description
covariate
Time Frame
post-intervention (12 weeks) + follow-up (+3 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Schwarz, PhD
Phone
+41442555645
Email
anne.schwarz@usz.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph Globas, MD
Organizational Affiliation
University Hospital and University of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ambulante Reha Triemli Zürich
City
Zürich
Country
Switzerland
Facility Name
Klinik Lengg AG
City
Zürich
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bartosz Bujan, MD
Phone
+41443876767
Email
bartosz.bujan@kliniklengg.ch
Facility Name
University Hospital Zurich
City
Zürich
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christoph Globas, MD
Phone
+41442555511
Email
christoph.globas@usz.ch

12. IPD Sharing Statement

Plan to Share IPD
No

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Perfusion Augmentation Through Exercise

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