Effects of Aerobic Exercise on the Cerebral Arterial System, Cognitive, and Motor Function in Post-stroke Patients.
A Study to Investigate the Effects of Aerobic Exercise Training (AET) on the Large Intracranial and Extracranial Cerebral Arteries and the Cognitive and Motor Functions in Post Stroke Patients.
2 other identifiers
interventional
120
1 country
1
Brief Summary
Background: Stroke is the second leading cause of death and disability worldwide and in Hong Kong, 6.2% of all registered deaths in 2020 were due to cerebrovascular disease. Exercise training has the potential to improve the deconditioned hemodynamic, motor, and cognitive functions associated with stroke. Purpose: The proposed study seeks to investigate the effects of AET on the large intracranial and extracranial cerebral arteries' morphological and haemodynamic features and the cognitive and motor functions in post-stroke chronic patients. Additionally, the study seeks to compare the cerebral arteries' features between post-stroke patients and age-matched controls without stroke. Furthermore, the project seeks to assess the association between the cerebrovascular system changes and the cognitive and motor function changes in post-stroke patients undergoing AET. Study Design: A Randomised controlled trial (RCT) in which the post-stroke patients will be randomly assigned into three groups consisting of a control group and two AET interventional groups (treadmill and cycle ergometer). Each group will target sample size of 20 participants. The target dosage for the two AET modes will consist of 1.) a session duration=30mins, 2.) frequency=3times/week, 3.) high intensity=(60-84% heart rate reserve (HHR).4.) Types=Treadmill and cycle ergometer 5.) overall program duration=3months. Data collection methods: Quantitative data on the cerebral arteries' haemodynamic and morphological features will be assessed using duplex carotid ultrasound (DCUS) and transcranial Doppler (TCD) ultrasound techniques. Montreal cognitive assessment (HK) version and six-minute walk test (6MWT) will assess cognitive and motor functions respectively. The data will be assessed at three time periods of during the 3 months AET program Significance of the study: The study has the potential to inform the clinical decision making process on the usefulness of AET in improving post-stroke chronic patients. Results on associations will provide a basis for future work in chronic stroke Rehabilitation functional outcome prediction models based on DCUS and TCD ultrasound imaging techniques.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started Feb 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 23, 2022
CompletedFirst Posted
Study publicly available on registry
January 31, 2023
CompletedStudy Start
First participant enrolled
February 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2024
CompletedFebruary 28, 2024
February 1, 2024
1.5 years
December 23, 2022
February 26, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (22)
Changes in the carotid intima media thickness (CIMT) following a 12weeks Aerobic exercise training (AET) programme as assessed by duplex carotid ultrasonography.
The Carotid intima media thickness (CIMT) for the 3 post stroke subjects groups (control, treadmill, and cycle ergometer) will be assessed using the semi-automated arterial analysis software on the Samsung RS80A ultrasound machine (Samsung Medison Co., Ltd., Republic of Korea)at 3 time periods (Baseline, midpoint at 6weeks, and at 12 weeks corresponding to end of the AET program). The changes in CIMT will be reported as: 1.) Overall Change score= mean differences (MD) between Baseline (enrolment) and end of AET programme (at 12weeks) CIMT absolute values, 2.)Percentage (%) change score= ((overall change score/ mean baseline CIMT values)\*100), and 3.)Standardized mean difference (SMD) = (mean difference between change scores in AET group and change scores in control group) divided by the mean standard deviation of the two groups.
Baseline(enrollment) to midpoint of AET at 6weeks and Baseline to end of AET at 12weeks
Changes in the Carotid arterial stiffness (CAS) following a 12weeks Aerobic exercise training (AET) programme as assessed by duplex carotid ultrasonography.
The Carotid arterial stiffness (CAS) for the 3 post stroke subjects groups (control, treadmill, and cycle ergometer) will be assessed using the semi-automated arterial analysis software on the Samsung RS80A ultrasound machine (Samsung Medison Co., Ltd., Republic of Korea) at 3 time periods (Baseline, midpoint at 6weeks, and at 12 weeks corresponding to end of the AET program). The changes in CAS will be reported as: 1,) Overall Change score= mean differences (MD) between Baseline (enrolment) and end of AET programme (at 12weeks) CAS Beta Stiffness Index (β) absolute values, 2.) Percentage (%) change score= (overall change score/ mean baseline CAS Beta Stiffness Index (β) values\*100), and 3.) Standardized mean difference (SMD) = (overall change score in AET group- change score in control group) divided by the mean standard deviation of the two groups.
Baseline(enrollment) to midpoint of AET at 6weeks and Baseline to end of AET at 12weeks
Changes in the degree of stenosis following a 12weeks Aerobic exercise training (AET) programme as assessed by duplex carotid ultrasonography.
The degree of stenosis for the 3 post stroke subjects groups (control, treadmill, and cycle ergometer) will be assessed using the 3D arterial analysis software on the Samsung RS80A ultrasound machine (Samsung Medison Co., Ltd., Republic of Korea) at 3 time periods (Baseline, midpoint at 6weeks, and at 12 weeks (corresponding to end of the AET program). The changes in the degree of stenosis will be reported as: 1.) Overall Change score= mean differences (MD) between Baseline (enrolment) and end of AET programme (at 12weeks) volume stenosis absolute values. 2.) Percentage (%) change score= ((overall change score/ mean baseline volume stenosis values)\*100), and 3.) Standardized mean difference (SMD) = (mean difference between change scores in AET group and change scores in control group) divided by the mean standard deviation of the two groups.
Baseline(enrollment) to midpoint of AET at 6weeks and Baseline to end of AET at 12weeks
Changes in the plaque Gray scale median values (GSM) following a 12weeks Aerobic exercise training (AET) programme as assessed by the Adobe Photoshop software.
The plaque Gray scale median values for the 3 post stroke subjects groups (control, treadmill, and cycle ergometer) will be assessed using the Adobe Photoshop software at 3 time periods (Baseline, midpoint at 6weeks, and at 12 weeks (corresponding to end of the AET program). The changes in GSM values will be reported as: 1.) Overall Change score= mean differences (MD) between Baseline (enrolment) and end of AET programme (at 12weeks) GSM values. 2.) Percentage (%) change score= ((overall change score/ mean baseline GSM values)\*100), and 3.) Standardized mean difference (SMD) = (mean difference between change scores in AET group and change scores in control group) divided by the mean standard deviation of the two groups.
Baseline(enrollment) to midpoint of AET at 6weeks and Baseline to end of AET at 12weeks
Changes in the cerebral arteries' Peak systolic velocity (PSV) following a 12weeks Aerobic exercise training (AET) programme as assessed by duplex carotid ultrasonography (DCUS) and Transcranial Doppler (TCD) Ultrasonography.
The cerebral arteries' Peak systolic velocity for the 3 post stroke subjects groups (control, treadmill, and cycle ergometer) will be assessed using Spectral Doppler analysis on the Samsung RS80A ultrasound machine (Samsung Medison Co., Ltd., Republic of Korea) at 3 time periods (Baseline, midpoint at 6weeks, and at 12 weeks corresponding to end of the AET program). The changes in PSV values will be reported as: 1.) Overall Change score= mean differences (MD) between Baseline (enrolment) and end of AET programme (at 12weeks) PSV values. 2.) Percentage (%) change score= ((overall change score/ mean baseline PSV values)\*100), and 3.) Standardized mean difference (SMD) = (mean difference between change scores in AET group and change scores in control group) divided by the mean standard deviation of the two groups.
Time Frame: Baseline(enrollment) to midpoint of AET at 6weeks and Baseline to end of AET at 12weeks
Changes in the cerebral arteries' End diastolic velocity (EDV) following a 12weeks Aerobic exercise training (AET) programme as assessed by duplex carotid ultrasonography.
The cerebral arteries' End diastolic velocity for the 3 post stroke subjects groups (control, treadmill, and cycle ergometer) will be assessed using Spectral Doppler analysis on the Samsung RS80A ultrasound machine (Samsung Medison Co., Ltd., Republic of Korea) at 3 time periods (Baseline, midpoint at 6weeks, and at 12 weeks corresponding to end of the AET program). The changes in EDV values will be reported as: 1.) Overall Change score= mean differences (MD) between Baseline (enrolment) and end of AET programme (at 12weeks) EDV values. 3.) Percentage (%) change score= ((overall change score/ mean baseline EDV values)\*100), and 4.) Standardized mean difference (SMD) = (mean difference between change scores in AET group and change scores in control group) divided by the mean standard deviation of the two groups.
Time Frame: Baseline(enrollment) to midpoint of AET at 6weeks and Baseline to end of AET at 12weeks
Changes in the cerebral arteries' mean flow velocity (MFV) following a 12weeks Aerobic exercise training (AET) programme as assessed by duplex carotid ultrasonography.
The cerebral arteries' mean flow velocity for the 3 post stroke subjects groups (control, treadmill, and cycle ergometer) will be assessed using Spectral Doppler analysis on the Samsung RS80A ultrasound machine (Samsung Medison Co., Ltd., Republic of Korea) at 3 time periods (Baseline, midpoint at 6weeks, and at 12 weeks corresponding to end of the AET program). The changes in MFV values will be reported as: 1.) Overall Change score= mean differences (MD) between Baseline (enrolment) and end of AET programme (at 12weeks) MFV values, 2.) Percentage (%) change score= ((overall change score/ mean baseline MFV values)\*100), and 3.) Standardized mean difference (SMD) = (mean difference between change scores in AET group and change scores in control group) divided by the mean standard deviation of the two groups.
Time Frame: Baseline(enrollment) to midpoint of AET at 6weeks and Baseline to end of AET at 12weeks
Changes in the cerebral arteries' Resistivity index (RI) following a 12weeks Aerobic exercise training (AET) programme as assessed by duplex carotid ultrasonography.
The cerebral arteries' Resistivity Index for the 3 post stroke subjects groups (control, treadmill, and cycle ergometer) will be assessed using Spectral Doppler analysis on the Samsung RS80A ultrasound machine (Samsung Medison Co., Ltd., Republic of Korea) at 3 time periods (Baseline, midpoint at 6weeks, and at 12 weeks corresponding to end of the AET program). The changes in PSV values will be reported as: 1.) Overall Change score= mean differences (MD) between Baseline (enrolment) and end of AET programme (at 12weeks) RI values, 2.) Percentage (%) change score= ((overall change score/ mean baseline RI values)\*100), and 3.) Standardized mean difference (SMD) = (mean difference between change scores in AET group and change scores in control group) divided by the mean standard deviation of the two groups.
Time Frame: Baseline(enrollment) to midpoint of AET at 6weeks and Baseline to end of AET at 12weeks
Changes in the cerebral arteries' Pulsatility index (PI) following a 12weeks Aerobic exercise training (AET) programme as assessed by duplex carotid ultrasonography.
The cerebral arteries' Pulsatility Index for the 3 post stroke subjects groups (control, treadmill, and cycle ergometer) will be assessed using Spectral Doppler analysis on the Samsung RS80A ultrasound machine (Samsung Medison Co., Ltd., Republic of Korea) at 3 time periods (Baseline, midpoint at 6weeks, and at 12 weeks corresponding to end of the AET program). The changes in PI values will be reported as: 1.) Overall Change score= mean differences (MD) between Baseline (enrolment) and end of AET programme (at 12weeks) PI values, 2.) Percentage (%) change score= ((overall change score/ mean baseline PI values)\*100), and 3.) Standardized mean difference (SMD) = (mean difference between change scores in AET group and change scores in control group) divided by the mean standard deviation of the two groups.
Time Frame: Baseline(enrollment) to midpoint of AET at 6weeks and Baseline to end of AET at 12weeks
Changes in the cognitive function as assessed by Montreal Cognitive assessment Hong Kong version Tool.
The Montreal Cognitive Assessment Hong Kong version(MCAHKv) scores for the 3 post stroke subjects groups (control, treadmill, and cycle ergometer) will be measured at 3 time periods (Baseline, midpoint at 6weeks, and at 12 weeks (end of the AET program)). The differences between Baseline (enrollment) scores and end of AET at 12weeks scores will represent the overall change score in the cognitive function that may be attributed to AET.
Time Frame: Baseline(enrollment) to midpoint of AET at 6weeks and Baseline to end of AET at 12weeks
Changes in the cognitive function as assessed by the Stroop word color Test (SWCT)Tool.
The Stroop color word test (SWCT) scores for the 3 post stroke subjects groups (control, treadmill, and cycle ergometer) will be measured at 3 time periods (Baseline, midpoint at 6weeks, and at 12 weeks (end of the AET program)). The differences between Baseline (enrollment) scores and end of AET at 12weeks scores will represent the overall change score in the cognitive function that may be attributed to AET.
Time Frame: Baseline(enrollment) to midpoint of AET at 6weeks and Baseline to end of AET at 12weeks
Changes in the motor function as assessed by the six minute walk test
The 6MWT distance for the 3 post stroke subjects groups (control, treadmill, and cycle ergometer) will be measured at 3 time periods (Baseline, midpoint at 6weeks, and at 12 weeks (end of the AET program)). The differences between Baseline (enrollment) scores and end of AET at 12weeks scores will represent the overall change score in the motor function(endurance) that may be attributed to AET.
Time Frame: Baseline(enrollment) to midpoint of AET at 6weeks and Baseline to end of AET at 12weeks
Changes in the motor function as assessed by the Timed up and go test(TUG).
The TUG test walk time for the 3 post stroke subjects groups (control, treadmill, and cycle ergometer) will be measured at 3 time periods (Baseline, midpoint at 6weeks, and at 12 weeks (end of the AET program)). The differences between Baseline (enrollment) scores and end of AET at 12weeks scores will represent the overall change score in the motor function (speed) that may be attributed to AET.
Time Frame: Baseline(enrollment) to midpoint of AET at 6weeks and Baseline to end of AET at 12weeks
Differences between the post-stroke patients and age-matched non-stroke subjects' carotid intima media thickness (CIMT) as assessed by duplex carotid ultrasonography.
The Carotid intima media thickness (CIMT) of the post-stroke patients and age-matched non-stroke subjects will be assessed using the semi-automated arterial analysis software on the Samsung RS80A ultrasound machine (Samsung Medison Co., Ltd., Republic of Korea) ultrasonography machine at one time period. The differences in CIMT between the two subject groups will be represented by1.) Absolute and 2.) Percentage (%) differences between the mean CIMT values of the two groups.
single point-Baseline
Differences between the post-stroke patients and age-matched non-stroke subjects' Carotid arterial stiffness (CAS), Beta Stiffness Index (β) as assessed by duplex carotid ultrasonography.
The Carotid arterial stiffness (CAS) of the post-stroke patients and age-matched non-stroke subjects are assessed using the semi-automated arterial analysis software on the Samsung RS80A ultrasound machine (Samsung Medison Co., Ltd., Republic of Korea) and compared at one time period. The differences in CAS between the two subject groups will be represented by: 1.) Absolute and 2.) Percentage (%) differences between the mean CAS beta Stiffness Index (β) values of the two groups.
single point-Baseline
Differences between the post-stroke patients and age-matched non-stroke subjects' degree of volume stenosis as assessed by 3 dimensional(3D) carotid ultrasonography.
The degree of carotid artery volume stenosis of the post-stroke patients and age-matched non-stroke subjects are assessed using the 3D arterial analysis software on the Samsung RS80A ultrasound machine (Samsung Medison Co., Ltd., Republic of Korea) and compared at one time period. The differences in the degree of volume stenosis between the two subject groups will be represented by the 1.) Absolute and 2.) Percentage (%) differences between the mean volume stenosis of the two groups, and 3.) Differences in proportions of participants with greater than 50% volume stenosis.
single point-Baseline
Differences between the post-stroke patients and age-matched non-stroke subjects' Plaque Gray scale median (GSM) values as assessed by Adobe Photoshop software.
The duplex carotid ultrasonography images showing Plaques for both the post-stroke participants and age-matched non-stroke participants will have the plaques GSM values assessed at one time period using an Adobe Photoshop software. 1.) Absolute and 2.) Percentage differences in the Plaque GSM values between the two groups will represent the differences in the Plaque GSM values of the two groups.
single point-Baseline
Differences between the post-stroke patients and age-matched non-stroke subjects' cerebral arteries Peak systolic velocity (PSV) as assessed by Duplex carotid ultrasonography (DCUS) and Transcranial Doppler (TCD) ultrasonography.
The cerebral arteries Peak systolic velocity of the post-stroke patients and age-matched non-stroke subjects will be assessed using the Samsung RS80A ultrasound machine (Samsung Medison Co., Ltd., Republic of Korea) Spectral Doppler Analysis (extracranial) and TCD(intracranial). The PSV between the two groups will be compared at one time period. 1.) Absolute and 2.) Percentage (%) differences in the PSV values will represent the differences in the PSV values of the two groups.
single point-Baseline
Differences between the post-stroke patients and age-matched non-stroke subjects' cerebral arteries End diastolic velocity (EDV) as assessed by Duplex carotid ultrasonography (DCUS) and transcranial Doppler (TCD) ultrasonography.
The cerebral arteries End diastolic velocity of the post-stroke patients and age-matched non-stroke subjects will be assessed using the Samsung RS80A ultrasound machine (Samsung Medison Co., Ltd., Republic of Korea) Spectral Doppler Analysis (extracranial) and TCD(intracranial). The EDV between the two groups will be compared at one time period. 1.) Absolute and 2.) Percentage (%) differences in the EDV values will represent the differences in the EDV of the two groups.
single point-Baseline
Differences between the post-stroke patients and age-matched non-stroke subjects' cerebral arteries Mean flow velocity (MFV) as assessed by Duplex carotid ultrasonography (DCUS) and transcranial Doppler (TCD) ultrasonography.
The cerebral arteries Mean flow velocity of the post-stroke patients and age-matched non-stroke subjects are assessed using the Samsung RS80A ultrasound machine (Samsung Medison Co., Ltd., Republic of Korea) Spectral Doppler Analysis (extracranial) and TCD(intracranial). The MFV between the two groups will be compared at one time period. 1.) Absolute and 2.) Percentage (%) differences in the MFV values will represent the differences in the MFV of the two groups.
single point-Baseline
Differences between the post-stroke patients and age-matched non-stroke subjects' cerebral arteries Resistivity Index (RI) as assessed by Duplex carotid ultrasonography (DCUS) and transcranial Doppler (TCD) ultrasonography.
The cerebral arteries Resistivity Index of the post-stroke patients and age-matched non-stroke subjects are assessed using the Samsung RS80A ultrasound machine (Samsung Medison Co., Ltd., Republic of Korea) Spectral Doppler Analysis (extracranial) and TCD(intracranial). The RI between the two groups will be compared at one time period. 1.) Absolute and 2.) Percentage (%) differences in the RI values will represent the differences in the RI of the two groups.
single point-Baseline
Differences between the post-stroke patients and age-matched non-stroke subjects' cerebral arteries Pulsatility Index (PI) as assessed by Duplex carotid ultrasonography (DCUS) and transcranial Doppler (TCD) ultrasonography.
The cerebral arteries Pulsatility Index of the post-stroke patients and age-matched non-stroke subjects are assessed using the Samsung RS80A ultrasound machine (Samsung Medison Co., Ltd., Republic of Korea) Spectral Doppler Analysis (extracranial) and TCD(intracranial). The PI between the two groups will be compared at one time period. 1.) Absolute and 2.) Percentage (%) differences in the PI values will represent the differences in the PI of the two groups.
single point-Baseline
Secondary Outcomes (18)
Pearson/Spearmen correlation coefficient between changes in carotid intima media thickness (CIMT) as assessed by duplex carotid ultrasonography and changes in Six minute walk distance (6MWD) following 12weeks of Aerobic exercise training (AET).
End of AET at 12 weeks
Pearson/Spearmen correlation coefficient between changes in Carotid Arterial stiffness (Beta Stiffness Index (β)) as assessed by duplex carotid ultrasonography and changes in Six minute walk distance (6MWD) after 12weeks of exercise (AET).
End of AET at 12 weeks
Pearson/Spearmen correlation coefficient between Changes in degree of volume stenosis as assessed by duplex carotid ultrasonography and changes in Six minute walk distance (6MWD) following 12weeks of Aerobic exercise training (AET).
End of AET at 12 weeks
Pearson/Spearmen correlation coefficient between Changes in Plaque Gray scale median (GSM) values and changes in Six minute walk distance (6MWD) following 12weeks of Aerobic exercise training (AET).
End of AET at 12 weeks
Pearson/Spearmen correlation coefficient between changes in Peak systolic velocity (PSV) as assessed by duplex carotid ultrasonography and changes in Six minute walk distance (6MWD) following 12weeks of Aerobic exercise training (AET).
End of AET at 12 weeks
- +13 more secondary outcomes
Study Arms (3)
Control group
NO INTERVENTIONThe participants in this category will not undergo any structured exercise training for the duration of the study.
Treadmill Group
EXPERIMENTALThe targeted treadmill exercise dosage will consist of 1.)a session duration=30mins, 2.) frequency=3times/wk and 3.) Intensity= (60-84% heart rate reserve (HHR).4.) overall program duration=3months.
Cycle ergometer Group
EXPERIMENTALThe targeted cycling exercise dosage will consist of 1.) a session duration=30mins, 2.) frequency=3times/wk and 3.) Intensity= (60-84% heart rate reserve (HHR).4.) overall program duration=3months.
Interventions
Treadmill exercise is a form of aerobic exercise training that involves the use of a treadmill machine in a structured exercise programs.
Cycle ergometer exercise is a form of aerobic exercise training that involves the use of a stationery recumbent bike in a structured exercise programs.
Eligibility Criteria
You may qualify if:
- Post stroke adult patients of Chinese origin, who are 50 years old or above,
- Time of stroke onset \>6months (chronic),
- Mild to moderate disability to be able to undertake aerobic exercise training (treadmill and stationery cycling),
- Not participating in a structured aerobic exercise training.
- Adults of Chinese origin who are 50 years old or above,
- No history of stroke or Transient Ischemic stroke (TIA).
You may not qualify if:
- Non-Chinese nationals,
- Time of stroke onset\<6months,
- Below 50 years of age,
- Currently participating in a structured aerobic exercise training,
- Cannot perform treadmill walking or stationery cycling, and
- Allergic to ultrasound gel.
- History of stroke or TIA.,
- Non-Chinese nationals,
- Below 50 years of age, and
- Allergic to ultrasound gel.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Hong Kong Polytechnic University
Kowloon, Hong Kong
Related Publications (20)
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PMID: 36229774BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael TC Ying, PhD
The Hong Kong Polytechnic University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The assessors evaluating the cognitive and motor function will be blinded of the outcomes from duplex carotid ultrasound and transcranial Doppler ultrasound and vice versa.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 23, 2022
First Posted
January 31, 2023
Study Start
February 10, 2023
Primary Completion
August 1, 2024
Study Completion
August 1, 2024
Last Updated
February 28, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share