NCT06913127 Does High-intensity Exercise Lead to Better Functional Outcomes Early After Stroke in an Inpatient Rehabilitation Setting?
| NCT ID | NCT06913127 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mah Shi Min |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2025-01-20 |
| Primary Completion | 2025-09-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 36 participants in total. It began in 2025-01-20 with a primary completion date of 2025-09-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
Inclusion Criteria: 1. Admitted for acute ischaemic or haemorrhagic stroke and requiring inpatient rehabilitation for stroke 2. First-ever, single, unilateral stroke 3. Aged 21-99 years old 4. Able to walk 10m overground with minimal or moderate physical assistance 5. Cleared by physician to be medically stable to participate in high intensity exercise (HIE) 6. Participants have to be warded for inpatient rehabilitation for at least 10 consecutive weekdays Exclusion Criteria: 1. Any central or peripheral nervous system or orthopedic injury that may limit ambulation or exercise 2. Uncontrolled cardiorespiratory disease 3. Inability to follow 3 steps commands 4. Patient unable to give consent for the study 5. Patient who is assessed unsuitable to don on the medical device fNIRS (eg patients who had undergone craniectomy and cranioplasty)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06913127 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 99 Years, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06913127 currently recruiting?
Yes, NCT06913127 is actively recruiting participants. Contact the research team at mah.shi.min@skh.com.sg for enrollment information.
Where is the NCT06913127 trial being conducted?
This trial is being conducted at Singapore, Singapore.
Who is sponsoring the NCT06913127 clinical trial?
NCT06913127 is sponsored by Mah Shi Min. The trial plans to enroll 36 participants.
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