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NCT06913127Recruiting

Does High-intensity Exercise Lead to Better Functional Outcomes Early After Stroke in an Inpatient Rehabilitation Setting?

Source: ClinicalTrials.gov · Last updated 13 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
36 (estimated)
First submitted
29 Mar 2025
Start date
20 Jan 2025
Primary completion date
20 Sept 2025
Lead sponsor
Mah Shi Min
Diseases
Stroke
NCT number
NCT06913127

What you commit to

  • Study type: Interventional
  • Planned participants: 36
  • From 20 Jan 2025 to the primary completion date, 20 Sept 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Uncontrolled cardiorespiratory disease

Other

  • Any central or peripheral nervous system or orthopedic injury that may limit ambulation or exercise
  • 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)

Who the study is looking for

  • 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

Age in the registry: 21 years to 99 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Sengkang General Hospital
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SingaporeSingaporeRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.