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

NCT06913127 | Recruiting DMC

• 1 other identifier: 2024-3187
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Stroke rehabilitation; High-intensity

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  At enrollment and at end of treatment at 2 weeks

Secondary Outcomes (2)

• Steps per day

  Daily, throughout 2-weeks intervention

• Physical Activity Log

  Daily, throughout 2-weeks intervention

Other Outcomes (1)

• fNIRS (functional near-infrared spectroscopy) during walking tasks

  At enrollment and at end of treatment at 2 weeks

Study Arms (2)

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)

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)

Other: High intensity exercise post stroke

Interventions

High intensity exercise post stroke OTHER

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.

High intensity exercise; Low intensity exercise

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mah Shi Min: lead

Study Sites (1)

Sengkang General Hospital

Singapore, 544886, Singapore

RECRUITING

Related Publications (4)

• 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.

  PMID: 26003127 BACKGROUND

• Globas 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.

  PMID: 21885867 BACKGROUND

• Chan, 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.

  BACKGROUND

• 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.

  PMID: 24375978 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Shi Min Mah

CONTACT

+6598780173; mah.shi.min@skh.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Principal Physiotherapist

Study Record Dates

• First Submitted: March 29, 2025
• First Posted: April 6, 2025
• Study Start: January 20, 2025
• Primary Completion: September 20, 2025
• Study Completion: September 20, 2025
• Last Updated: April 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)