StrokeNCT06913127
Does High-intensity Exercise Lead to Better Functional Outcomes Early After Stroke in an Inpatient Rehabilitation Setting?
A study testing High intensity exercise post stroke in people with Stroke, run by Mah Shi Min at 1 site in Singapore.
Trial summary
The purpose of this study is to find out the effectiveness of high intensity exercise (HIE) early after stroke, this study is hoping to recruit 36 participants in total and will be analysing pre- and post- outcomes of patients in a high intensity exercise intervention, as compared to a lower intensity exercise… Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Stroke
- What is being tested?
- High intensity exercise post stroke
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSingapore
- Study dates
- 20 Jan 2025to 20 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted for acute ischaemic or haemorrhagic stroke and requiring inpatient rehabilitation for stroke
- First-ever, single, unilateral stroke
- Aged 21-99 years old
- Able to walk 10m overground with minimal or moderate physical assistance
- Cleared by physician to be medically stable to participate in high intensity exercise (HIE)
- Participants have to be warded for inpatient rehabilitation for at least 10 consecutive weekdays
Who cannot join
- Any central or peripheral nervous system or orthopedic injury that may limit ambulation or exercise
- Uncontrolled cardiorespiratory disease
- Inability to follow 3 steps commands
- Patient unable to give consent for the study
- Patient who is assessed unsuitable to don on the medical device fNIRS (eg patients who had undergone craniectomy and cranioplasty)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
Sengkang General Hospital
Singapore, 544886
Shi Min Mah, +6598780173, mah.shi.min@skh.com.sg
Qiao Qi Teo
About this study
The purpose of this study is to find out the effectiveness of high intensity exercise (HIE) early after stroke, this study is hoping to recruit 36 participants in total and will be analysing pre- and post- outcomes of patients in a high intensity exercise intervention, as compared to a lower intensity exercise programme. Participants will be randomly assigned to either the high or low intensity exercise programme, and receiving the assigned intervention for 2 weeks. Both groups in the study will be subjected to same post-stroke functional and locomotion training as part of their physiotherapy intervention, but at different intensities. This ranges from body weight supported training, to treadmill training, to robotics walking and functional training (including overground walking/ stepping and cardiorespiratory fitness training), as per conventional post-stroke rehabilitation.
The high intensity experimental group will undergo high-intensity exercise (HIE) training defined by 60-84% (heart rate reserve), or RPE (rate of perceived exertion) Borg 14-16, while the low intensity control group will undergo lower intensity training defined by HRR 59% and below, or RPE Borg 13 and below.
Measurements will be taken from assessments at pre- and post- interventions will be analysed and compared between the two groups to find out which intervention programme is more effective for patients early after stroke. These assessments include functional outcomes such as walking speed, chair rise test and also a neurobiological measure looking at levels of cortical activation called the functional near infrared spectroscopy (fNIRS) which is measured via a non-invasive cap that you wear on. The participants will be expected to don on the fNIRS device for a total of 15-30 minutes, and an average of 3 sets of 30-seconds measurements during their walking assessment will be taken.
Read the detailed description
Research participants are warded in an inpatient rehabilitation unit during the duration of the intervention. Prior to the enrolment of the patients into the study, the neurologist/ neurosurgeon or primary physician will be consulted of the suitability of their patient in performing high intensity exercise during their physiotherapy sessions as part of this trial. The exercise intensity parameters that the participants will be subjected to, will also be informed to the medical team before the start of the exercise intervention, with clarifications on any additional precautions or parameters to adhere to, to ensure that the participants are fit and safe to be recruited into this exercise trial. After enrolment, participants will be randomized into experimental and control group by concealed allocation by a neutral party.
Pre- and post- intervention outcomes will be measured by blinded therapists, and compared between groups; the outcome measurements include Functional Independence Measure (FIM), Berg Balance Scale (BBS), Mobility Scale for Acute Stroke (MSAS), Five time Sit to Stand Test (5 STS), gait speed, fatigue severity scale (FSS), and motivation in stroke patients for rehabilitation (MORE) scale. The outcomes will be recorded and analyzed to examine the effectiveness of high intensity exercise (HIE) post stroke. Functional near infrared spectroscopy (fNIRS), a non-invasive optical brain monitoring device, will be donned on during walking tests to monitor and compare the cortical activity in both groups. An average of 3 sets of 30-second measurements with the fNIRS will be taken during walking, the participant will be expected to wear the device for 15-30 minutes. Physical activity tracking via number of steps/ day and activity log will be used to monitor the effects of the interventions on the patients' activity levels while warded.
Exercise intervention: All patients will be subjected to standard post-stroke functional and locomotion training as part of their physiotherapy intervention. This ranges from body weight supported training, to treadmill training, to robotics walking and functional training (including overground walking/ stepping and cardiorespiratory fitness training), as per conventional post-stroke rehabilitation. Both groups will undergo the same training as described above, prescribed by their physiotherapist; the only difference is the intensity of the exercise. The experimental group will undergo high-intensity exercise (HIE) training defined by 60- 84% HRR (heart rate reserve) or RPE (rate of perceived exertion) Borg Scale 14-16, while the control group will undergo lower intensity training defined by HRR 59% and below, or RPE Borg 13 and below.
Safety monitoring: Prior to start of exercise interventions, patients will be asked if they feel unwell or present with any symptoms that are of concern, their vitals (HR, BP, RR and spO2) will be taken. Throughout the session, HR will be monitored and spO2, BP and RR will be taken every 2-5 minutes to ensure that they are within safe limits. Immediately after exercise and post session, patients will be asked for their symptoms and vitals will again be taken. All vitals monitoring will be recorded, and the attending physiotherapist or patient is able to stop the intervention at any time if they feel that the physiological measures/ responses are not within safe limits for the intervention to continue.
In accordance to literature review of similar topics, post stroke exercise intensity in this study will be definedas such: Target HR= Target HRR % x (HR max- HR resting)+ HR resting HR max for people not on beta-blockers= 206.9 - (0.67 x Age) HR max for people on beta-blockers: 164 - (0.7 x Age) High intensity exercise: 60-84% HRR OR RPE Borg 14-16
A medical record review of the patients enrolled into the study will be conducted where patient characteristics, including demographic data, type of stroke, site of lesion, stroke severity (NIHSS), nature of impairments, cognitive level (MOCA) and use of medications, premorbid and pre-rehabilitation functional status will be documented. Functional outcome measures will be evaluated at the start and end of the intervention period (i.e. after 2 weeks, 10 days bidaily- 20 sessions) of inpatient rehabilitation training.
Data analysis: Statistical analysis will be conducted to examine the difference in outcomes between the experimental and control groups. If the hypotheses of this study that HIE is more effective in improving outcomes as compared to low intensity is proven to be accurate, this will have clinical implications in provision of high quality evidence based care as it contributes to advocating for HIE to implemented in standard stroke care in the acute inpatient rehabilitation centres in Singapore, and worldwide.
- Conditions
- Stroke
- Being tested
- High intensity exercise post stroke
- Keywords
- Stroke rehabilitation, High-intensity
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity exercise post strokeOther
The patients are all admitted with an acute/ subacute stroke in an inpatient rehabilitation ward. They are randomized into a high intensity exercise or a low intensity exercise group that will last for 20 consecutive sessions. At the end of the experimental period, outcomes including functional outcomes, questionnaires, physical activity and fNIRS (functional near infrared spectroscopy) measurements will be compared between the two groups.
| Study group | Role | What they receive |
|---|---|---|
| High intensity exercise | Experimental | High intensity exercise: 60-84% HRR (heart rate reserve) or RPE (rate of perceived exertion) 14-16 HR max for people on beta-blockers: 164- (0.7 x Age) HR max for people not on beta-blockers: 206.9 -(0.67 x Age) Receives: Other: High intensity exercise post stroke |
| Low intensity exercise | Active comparator | Low intensity exercise: 59% HRR and below (heart rate reserve) or RPE (rate of perceived exertion) 13 and below HR max for people on beta-blockers: 164- (0.7 x Age) HR max for people not on beta-blockers: 206.9 -(0.67 x Age) Receives: Other: High intensity exercise post stroke |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Independence Measure
The FIM (Functional Independence Measure) score is a standardized tool used to assess a patient's functional independence during rehabilitation, with scores ranging from 18 to 126, where higher scores indicate greater independence.
Measured: At enrollment and at end of treatment at 2 weeks
Berg Balance Scale
The Berg balance scale (BBS) is widely used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a set of 14 simple balance related tasks, ranging from standing up from a sitting position to standing on one foot, and takes approximately 20 minutes to complete. Each item is scored 0 to 4, resulting in a total score ranging from 0 to 56, where higher scores indicate better balance.
Measured: At enrollment and at end of treatment at 2 weeks
Mobility Scale for Acute Stroke (MSAS)
The Mobility Scale for Acute Stroke (MSAS) is a unidimensional instrument that produces a single aggregate score from 6 basic mobility activities that correspond with the range of abilities seen in people with acute stroke. The 6 activities are scored using a 6-point scale, with total scores ranging from 6 to 36, where a lower score indicates more assistance is required.
Measured: At enrollment and at end of treatment at 2 weeks
Five Times Sit to Stand Test
The Five Times Sit to Stand Test (5x Sit-To-Stand Test) is commonly abbreviated as 5XSST. It's used to asses functional lower limbs strength, transitional movements, balance, and fall risk.
Measured: At enrollment and at end of treatment at 2 weeks
Gait Speed
Gait speed, or walking speed, is a measure of how quickly someone can walk a specified distance, calculated by dividing the distance by the time taken, and is often expressed in meters per second (m/s). It's a valuable indicator of functional ability and can be used to assess fall risk.
Measured: At enrollment and at end of treatment at 2 weeks
Fatigue Severity Scale
The Fatigue Severity Scale (FSS) is a 9-item questionnaire used to measure the severity of fatigue and its impact on daily life, with higher scores indicating greater fatigue.
Measured: At enrollment and at end of treatment at 2 weeks
Motivation in stroke patients for rehabilitation (MORE) scale
The MORE scale, or Motivation in stroke patients for rehabilitation scale, is a 17-item tool developed to assess stroke patients' motivation for rehabilitation, exploring both intrinsic and extrinsic factors, with higher scores indicating higher motivation.
Measured: At enrollment and at end of treatment at 2 weeks
Secondary outcomes (2)
Steps per day
Steps per day will be tracked, and recorded.
Measured: Daily, throughout 2-weeks intervention
Physical Activity Log
Patients will record the physical activity he/ she performed that day, as well as how he/ she felt, and any additional comments.
Measured: Daily, throughout 2-weeks intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start20 Jan 2025
- Primary completion20 Sep 2025 (estimated)
- Study completion20 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mah Shi Min
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mah Shi Min, Sengkang General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06913127
- Sponsor's protocol ID
- 2024-3187
- Status last verified
- Mar 2025
- First submitted
- 29 Mar 2025
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data is intended to be shared at conference, and yet to be published.
Publications
Robertson AD, Crane DE, Rajab AS, Swardfager W, Marzolini S, Shirzadi Z, Middleton LE, MacIntosh BJ. Exercise intensity modulates the change in cerebral blood flow following aerobic exercise in chronic stroke. Exp Brain Res. 2015 Aug;233(8):2467-75. doi: 10.1007/s00221-015-4317-6. Epub 2015 May 24.
PubMed 26003127Globas C, Becker C, Cerny J, Lam JM, Lindemann U, Forrester LW, Macko RF, Luft AR. Chronic stroke survivors benefit from high-intensity aerobic treadmill exercise: a randomized control trial. Neurorehabil Neural Repair. 2012 Jan;26(1):85-95. doi: 10.1177/1545968311418675. Epub 2011 Sep 1.
PubMed 21885867Chan, C. Y., Mullen, M., Burrows, J., Kerr, I., Petrunia, C., Dawson, A., & Feehan, L. (2015). Targeted dischargeplanning for stroke clients in high intensity rehabilitation settings is associated with a notable reductioninlength of stay. International Journal of Stroke, 10, 78-78.
Askim T, Dahl AE, Aamot IL, Hokstad A, Helbostad J, Indredavik B. High-intensity aerobic interval training for patients 3-9 months after stroke: a feasibility study. Physiother Res Int. 2014 Sep;19(3):129-39. doi: 10.1002/pri.1573. Epub 2013 Dec 4.
PubMed 24375978
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does High-intensity Exercise Lead to Better Functional Outcomes Early After Stroke in an Inpatient Rehabilitation Setting?
- ClinicalTrials.gov ID
- NCT06913127
- Acronym / sponsor ID
- 2024-3187
- Conditions
- Stroke
- Keywords
- Stroke rehabilitation, High-intensity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Mah Shi MinUniversity, hospital or other
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 20 Sep 2025 (estimated)
- Study completion
- 20 Sep 2025 (estimated)
- First posted
- 6 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out the effectiveness of high intensity exercise (HIE) early after stroke, this study is hoping to recruit 36 participants in total and will be analysing pre- and post- outcomes of patients in a high intensity exercise intervention, as compared to a lower intensity exercise programme. Participants will be randomly assigned to either the high or low intensity exercise programme, and receiving the assigned intervention for 2 weeks. Both groups in the study will be subjected to same post-stroke functional and locomotion training as part of their physiotherapy intervention, but at different intensities. This ranges from body weight supported training, to treadmill training, to robotics walking and functional training (including overground walking/ stepping and cardiorespiratory fitness training), as per conventional post-stroke rehabilitation.
The high intensity experimental group will undergo high-intensity exercise (HIE) training defined by 60-84% (heart rate reserve), or RPE (rate of perceived exertion) Borg 14-16, while the low intensity control group will undergo lower intensity training defined by HRR 59% and below, or RPE Borg 13 and below.
Measurements will be taken from assessments at pre- and post- interventions will be analysed and compared between the two groups to find out which intervention programme is more effective for patients early after stroke. These assessments include functional outcomes such as walking speed, chair rise test and also a neurobiological measure looking at levels of cortical activation called the functional near infrared spectroscopy (fNIRS) which is measured via a non-invasive cap that you wear on. The participants will be expected to don on the fNIRS device for a total of 15-30 minutes, and an average of 3 sets of 30-seconds measurements during their walking assessment will be taken.
Detailed description
Research participants are warded in an inpatient rehabilitation unit during the duration of the intervention. Prior to the enrolment of the patients into the study, the neurologist/ neurosurgeon or primary physician will be consulted of the suitability of their patient in performing high intensity exercise during their physiotherapy sessions as part of this trial. The exercise intensity parameters that the participants will be subjected to, will also be informed to the medical team before the start of the exercise intervention, with clarifications on any additional precautions or parameters to adhere to, to ensure that the participants are fit and safe to be recruited into this exercise trial. After enrolment, participants will be randomized into experimental and control group by concealed allocation by a neutral party.
Pre- and post- intervention outcomes will be measured by blinded therapists, and compared between groups; the outcome measurements include Functional Independence Measure (FIM), Berg Balance Scale (BBS), Mobility Scale for Acute Stroke (MSAS), Five time Sit to Stand Test (5 STS), gait speed, fatigue severity scale (FSS), and motivation in stroke patients for rehabilitation (MORE) scale. The outcomes will be recorded and analyzed to examine the effectiveness of high intensity exercise (HIE) post stroke. Functional near infrared spectroscopy (fNIRS), a non-invasive optical brain monitoring device, will be donned on during walking tests to monitor and compare the cortical activity in both groups. An average of 3 sets of 30-second measurements with the fNIRS will be taken during walking, the participant will be expected to wear the device for 15-30 minutes. Physical activity tracking via number of steps/ day and activity log will be used to monitor the effects of the interventions on the patients' activity levels while warded.
Exercise intervention: All patients will be subjected to standard post-stroke functional and locomotion training as part of their physiotherapy intervention. This ranges from body weight supported training, to treadmill training, to robotics walking and functional training (including overground walking/ stepping and cardiorespiratory fitness training), as per conventional post-stroke rehabilitation. Both groups will undergo the same training as described above, prescribed by their physiotherapist; the only difference is the intensity of the exercise. The experimental group will undergo high-intensity exercise (HIE) training defined by 60- 84% HRR (heart rate reserve) or RPE (rate of perceived exertion) Borg Scale 14-16, while the control group will undergo lower intensity training defined by HRR 59% and below, or RPE Borg 13 and below.
Safety monitoring: Prior to start of exercise interventions, patients will be asked if they feel unwell or present with any symptoms that are of concern, their vitals (HR, BP, RR and spO2) will be taken. Throughout the session, HR will be monitored and spO2, BP and RR will be taken every 2-5 minutes to ensure that they are within safe limits. Immediately after exercise and post session, patients will be asked for their symptoms and vitals will again be taken. All vitals monitoring will be recorded, and the attending physiotherapist or patient is able to stop the intervention at any time if they feel that the physiological measures/ responses are not within safe limits for the intervention to continue.
In accordance to literature review of similar topics, post stroke exercise intensity in this study will be definedas such: Target HR= Target HRR % x (HR max- HR resting)+ HR resting HR max for people not on beta-blockers= 206.9 - (0.67 x Age) HR max for people on beta-blockers: 164 - (0.7 x Age) High intensity exercise: 60-84% HRR OR RPE Borg 14-16
A medical record review of the patients enrolled into the study will be conducted where patient characteristics, including demographic data, type of stroke, site of lesion, stroke severity (NIHSS), nature of impairments, cognitive level (MOCA) and use of medications, premorbid and pre-rehabilitation functional status will be documented. Functional outcome measures will be evaluated at the start and end of the intervention period (i.e. after 2 weeks, 10 days bidaily- 20 sessions) of inpatient rehabilitation training.
Data analysis: Statistical analysis will be conducted to examine the difference in outcomes between the experimental and control groups. If the hypotheses of this study that HIE is more effective in improving outcomes as compared to low intensity is proven to be accurate, this will have clinical implications in provision of high quality evidence based care as it contributes to advocating for HIE to implemented in standard stroke care in the acute inpatient rehabilitation centres in Singapore, and worldwide.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High intensity exercise | Experimental | Other: High intensity exercise post strokeHigh intensity exercise: 60-84% HRR (heart rate reserve) or RPE (rate of perceived exertion) 14-16 HR max for people on beta-blockers: 164- (0.7 x Age) HR max for people not on beta-blockers: 206.9 -(0.67 x Age) |
| Low intensity exercise | Active comparator | Other: High intensity exercise post strokeLow intensity exercise: 59% HRR and below (heart rate reserve) or RPE (rate of perceived exertion) 13 and below HR max for people on beta-blockers: 164- (0.7 x Age) HR max for people not on beta-blockers: 206.9 -(0.67 x Age) |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Admitted for acute ischaemic or haemorrhagic stroke and requiring inpatient rehabilitation for stroke
- First-ever, single, unilateral stroke
- Aged 21-99 years old
- Able to walk 10m overground with minimal or moderate physical assistance
- Cleared by physician to be medically stable to participate in high intensity exercise (HIE)
Key exclusion criteria (5 listed)
- Any central or peripheral nervous system or orthopedic injury that may limit ambulation or exercise
- Uncontrolled cardiorespiratory disease
- Inability to follow 3 steps commands
- Patient unable to give consent for the study
- Patient who is assessed unsuitable to don on the medical device fNIRS (eg patients who had undergone craniectomy and cranioplasty)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High intensity exercise post strokeThe patients are all admitted with an acute/ subacute stroke in an inpatient rehabilitation ward. They are randomized into a high intensity exercise or a low intensity exercise group that will last for 20 consecutive sessions. At the end of the experimental period, outcomes including functional outcomes, questionnaires, physical activity and fNIRS (functional near infrared spectroscopy) measurements will be compared between the two groups. | Other | High intensity exercise, Low intensity exercise |
Primary outcome
Functional Independence Measure
Time frame: At enrollment and at end of treatment at 2 weeks
The FIM (Functional Independence Measure) score is a standardized tool used to assess a patient's functional independence during rehabilitation, with scores ranging from 18 to 126, where higher scores indicate greater independence.
Berg Balance Scale
Time frame: At enrollment and at end of treatment at 2 weeks
The Berg balance scale (BBS) is widely used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a set of 14 simple balance related tasks, ranging from standing up from a sitting position to standing on one foot, and takes approximately 20 minutes to complete. Each item is scored 0 to 4, resulting in a total score ranging from 0 to 56, where higher scores indicate better balance.
Mobility Scale for Acute Stroke (MSAS)
Time frame: At enrollment and at end of treatment at 2 weeks
The Mobility Scale for Acute Stroke (MSAS) is a unidimensional instrument that produces a single aggregate score from 6 basic mobility activities that correspond with the range of abilities seen in people with acute stroke. The 6 activities are scored using a 6-point scale, with total scores ranging from 6 to 36, where a lower score indicates more assistance is required.
Five Times Sit to Stand Test
Time frame: At enrollment and at end of treatment at 2 weeks
The Five Times Sit to Stand Test (5x Sit-To-Stand Test) is commonly abbreviated as 5XSST. It's used to asses functional lower limbs strength, transitional movements, balance, and fall risk.
Gait Speed
Time frame: At enrollment and at end of treatment at 2 weeks
Gait speed, or walking speed, is a measure of how quickly someone can walk a specified distance, calculated by dividing the distance by the time taken, and is often expressed in meters per second (m/s). It's a valuable indicator of functional ability and can be used to assess fall risk.
Fatigue Severity Scale
Time frame: At enrollment and at end of treatment at 2 weeks
The Fatigue Severity Scale (FSS) is a 9-item questionnaire used to measure the severity of fatigue and its impact on daily life, with higher scores indicating greater fatigue.
Motivation in stroke patients for rehabilitation (MORE) scale
Time frame: At enrollment and at end of treatment at 2 weeks
The MORE scale, or Motivation in stroke patients for rehabilitation scale, is a 17-item tool developed to assess stroke patients' motivation for rehabilitation, exploring both intrinsic and extrinsic factors, with higher scores indicating higher motivation.
2 secondary outcomes
Steps per day
Time frame: Daily, throughout 2-weeks intervention
Physical Activity Log
Time frame: Daily, throughout 2-weeks intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Results publication: PubMed 26003127Robertson AD, Crane DE, Rajab AS, Swardfager W, Marzolini S, Shirzadi Z, Middleton LE, MacIntosh BJ. Exercise intensity modulates the change in cerebral blood flow following aerobic exercise in chronic stroke. Exp Brain Res. 2015 Aug;233(8):2467-75. doi: 10.1007/s00221-015-4317-6. Epub 2015 May 24.
- Results publication: PubMed 21885867Globas C, Becker C, Cerny J, Lam JM, Lindemann U, Forrester LW, Macko RF, Luft AR. Chronic stroke survivors benefit from high-intensity aerobic treadmill exercise: a randomized control trial. Neurorehabil Neural Repair. 2012 Jan;26(1):85-95. doi: 10.1177/1545968311418675. Epub 2011 Sep 1.
- Results publicationChan, C. Y., Mullen, M., Burrows, J., Kerr, I., Petrunia, C., Dawson, A., & Feehan, L. (2015). Targeted dischargeplanning for stroke clients in high intensity rehabilitation settings is associated with a notable reductioninlength of stay. International Journal of Stroke, 10, 78-78.
- Results publication: PubMed 24375978Askim T, Dahl AE, Aamot IL, Hokstad A, Helbostad J, Indredavik B. High-intensity aerobic interval training for patients 3-9 months after stroke: a feasibility study. Physiother Res Int. 2014 Sep;19(3):129-39. doi: 10.1002/pri.1573. Epub 2013 Dec 4.
- Individual participant dataSharing planned: No. The data is intended to be shared at conference, and yet to be published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity exercise post stroke in people with Stroke, run by Mah Shi Min at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shi Min Mah (+6598780173, mah.shi.min@skh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Independence Measure (time frame: At enrollment and at end of treatment at 2 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06913127, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025.