NCT05706168

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

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 31, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

February 10, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

1.5 years

First QC Date

December 23, 2022

Last Update Submit

February 26, 2024

Conditions

Keywords

: post strokecerebral arteriesaerobic exercise trainingduplex carotid ultrasound (DCUS)transcranial Doppler (TCD) ultrasound.

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 INTERVENTION

The participants in this category will not undergo any structured exercise training for the duration of the study.

Treadmill Group

EXPERIMENTAL

The 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.

Device: treadmill exercise

Cycle ergometer Group

EXPERIMENTAL

The 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.

Device: Cycle ergometer exercise

Interventions

Treadmill exercise is a form of aerobic exercise training that involves the use of a treadmill machine in a structured exercise programs.

Treadmill Group

Cycle ergometer exercise is a form of aerobic exercise training that involves the use of a stationery recumbent bike in a structured exercise programs.

Cycle ergometer Group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

RECRUITING

Related Publications (20)

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    PMID: 34487721BACKGROUND
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    PMID: 34079702BACKGROUND
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    PMID: 23428993BACKGROUND
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    PMID: 34306452BACKGROUND
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    PMID: 27531500BACKGROUND
  • Bartel L, Mosabbir A. Possible Mechanisms for the Effects of Sound Vibration on Human Health. Healthcare (Basel). 2021 May 18;9(5):597. doi: 10.3390/healthcare9050597.

    PMID: 34069792BACKGROUND
  • Billinger SA, Mattlage AE, Ashenden AL, Lentz AA, Harter G, Rippee MA. Aerobic exercise in subacute stroke improves cardiovascular health and physical performance. J Neurol Phys Ther. 2012 Dec;36(4):159-65. doi: 10.1097/NPT.0b013e318274d082.

    PMID: 23111686BACKGROUND
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    PMID: 28084167BACKGROUND
  • Ivey FM, Ryan AS, Hafer-Macko CE, Macko RF. Improved cerebral vasomotor reactivity after exercise training in hemiparetic stroke survivors. Stroke. 2011 Jul;42(7):1994-2000. doi: 10.1161/STROKEAHA.110.607879. Epub 2011 Jun 2.

    PMID: 21636819BACKGROUND
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    PMID: 32600741BACKGROUND
  • Kalkonde YV, Alladi S, Kaul S, Hachinski V. Stroke Prevention Strategies in the Developing World. Stroke. 2018 Dec;49(12):3092-3097. doi: 10.1161/STROKEAHA.118.017384. No abstract available.

    PMID: 30571438BACKGROUND
  • Madhavan S, Lim H, Sivaramakrishnan A, Iyer P. Effects of high intensity speed-based treadmill training on ambulatory function in people with chronic stroke: A preliminary study with long-term follow-up. Sci Rep. 2019 Feb 13;9(1):1985. doi: 10.1038/s41598-018-37982-w.

    PMID: 30760772BACKGROUND
  • Maiorana A, O'Driscoll G, Taylor R, Green D. Exercise and the nitric oxide vasodilator system. Sports Med. 2003;33(14):1013-35. doi: 10.2165/00007256-200333140-00001.

    PMID: 14599231BACKGROUND
  • Mitchell CC, Stein JH, Cook TD, Salamat S, Wang X, Varghese T, Jackson DC, Sandoval Garcia C, Wilbrand SM, Dempsey RJ. Histopathologic Validation of Grayscale Carotid Plaque Characteristics Related to Plaque Vulnerability. Ultrasound Med Biol. 2017 Jan;43(1):129-137. doi: 10.1016/j.ultrasmedbio.2016.08.011. Epub 2016 Oct 5.

    PMID: 27720278BACKGROUND
  • Mkoba EM, Sundelin G, Sahlen KG, Sorlin A. The characteristics of stroke and its rehabilitation in Northern Tanzania. Glob Health Action. 2021 Jan 1;14(1):1927507. doi: 10.1080/16549716.2021.1927507.

    PMID: 34340643BACKGROUND
  • Naqvi J, Yap KH, Ahmad G, Ghosh J. Transcranial Doppler ultrasound: a review of the physical principles and major applications in critical care. Int J Vasc Med. 2013;2013:629378. doi: 10.1155/2013/629378. Epub 2013 Dec 12.

    PMID: 24455270BACKGROUND
  • Purkayastha S, Sorond F. Transcranial Doppler ultrasound: technique and application. Semin Neurol. 2012 Sep;32(4):411-20. doi: 10.1055/s-0032-1331812. Epub 2013 Jan 29.

    PMID: 23361485BACKGROUND
  • Treger I, Aidinof L, Lutsky L, Kalichman L. Mean flow velocity in the middle cerebral artery is associated with rehabilitation success in ischemic stroke patients. Arch Phys Med Rehabil. 2010 Nov;91(11):1737-40. doi: 10.1016/j.apmr.2010.08.008.

    PMID: 21044719BACKGROUND
  • Wang YJ, Li ZX, Gu HQ, Zhai Y, Jiang Y, Zhao XQ, Wang YL, Yang X, Wang CJ, Meng X, Li H, Liu LP, Jing J, Wu J, Xu AD, Dong Q, Wang D, Zhao JZ; China Stroke Statistics 2019 Writing Committee. China Stroke Statistics 2019: A Report From the National Center for Healthcare Quality Management in Neurological Diseases, China National Clinical Research Center for Neurological Diseases, the Chinese Stroke Association, National Center for Chronic and Non-communicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention and Institute for Global Neuroscience and Stroke Collaborations. Stroke Vasc Neurol. 2020 Sep;5(3):211-239. doi: 10.1136/svn-2020-000457. Epub 2020 Aug 21.

    PMID: 32826385BACKGROUND
  • Woldeamanuel YW, Oliveira ABD. What is the efficacy of aerobic exercise versus strength training in the treatment of migraine? A systematic review and network meta-analysis of clinical trials. J Headache Pain. 2022 Oct 13;23(1):134. doi: 10.1186/s10194-022-01503-y.

    PMID: 36229774BACKGROUND

Related Links

MeSH Terms

Conditions

StrokeChoroideremia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesEye Diseases, HereditaryEye DiseasesChoroid DiseasesUveal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, X-Linked

Study Officials

  • Michael TC Ying, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

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
Model Details: The post-stroke chronic patients will be randomly assigned into three groups consisting of a non- interventional (control group) and two aerobic exercise interventional groups (treadmill and cycle ergometer). The enrollment for the three groups will be concurrent for the whole duration of the study. The quantitative data on the large extracranial and intracranial cerebral arteries haemodynamic and morphological features as determined by duplex carotid ultrasound and transcranial Doppler ultrasound, and the quantitative data on the cognitive and motor function of the patients will be collected and analysed at 3 time periods (baseline (before intervention), 6 weeks, and 12 weeks)
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

Locations