Multi-modal Training Program to Promote Physical Activity After Stroke

April 23, 2026 updated by: Singapore General Hospital

Multi-mOdal Training Program to Promote Physical actIVity After sTrokE: MOTIVATE

The goal of this study is to learn if a behavioral change intervention can improve physical activity in stroke survivors living in the community.

The main question it aims to answer is, if a behaviour change intervention and personalised physical activity prescription, are effective in improving the time spent in moderate to vigorous physical activity amongst chronic stroke survivors.

Researchers will compare the intervention group to a control group, to see if physical activity counselling and a personalized physical activity prescription is more effective in improving moderate to vigorous physical activity, than usual care alone. The study period for each participant is 6 months. Assessments are conducted at month 1 (baseline), 3 and 6.

The control group will receive only usual care, which consists of an information sheet on physical activity with the following content: (1) Why be active and (2) How to be active (with URL links to resources and videos). The usual care is delivered at 3-time points during month 1, 3 and 6.

The intervention group will receive usual care and a behavioral change intervention. The behavioral change intervention consists of up to 6 individual physical activity counselling sessions and a personalized physical activity prescription. The 6 sessions will take place only during months 1 to 3 and there will be no intervention during months 4 to 6. Of the 6 sessions, 3 are conducted face-to-face and another 3 sessions will take place using telehealth methods such as phone, text messaging and videoconference. Participants can meet the study physiotherapist at their preferred exercise space during the 3 face-to-face sessions. The physical activity counselling sessions consist of goal setting and action planning, and problem-solving barriers around participation in physical activity. The overall aim is to increase time spent in moderate-vigorous physical activity.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The MOTIVATE study will take place in Singapore with participants recruited through hospital-based stroke clinics, rehabilitation facilities, and stroke support organizations via posters, email, word of mouth, and social media. Potential participants can sign up by self-registering on the study URL link or through referrals from healthcare professionals and study members. Participants will be screened for eligibility via telephone using the inclusion and exclusion criteria and the Get Active Questionnaire. Participants. Those who have not engaged in regular exercise are required to obtain medical clearance. Informed consent will be taken by a study team member.

This trial will use a 1:1 concealed randomisation, to allocate participants with chronic stroke to an intervention group (n= 60) or control group (n = 60). Between-group comparisons will be made at 3 time points: months 1, 3 and 6.

The control group will receive usual care, which consists of 3 face-to-face sessions on general physical activity recommendations, lasting 30 to 60 minutes each during months 1, 3, and 6. Participants will be given an information sheet on the importance and benefits of physical activity after a stroke and general guidelines on how to start to be active. The general guidelines on how to be active include engaging in 150 minutes of moderate-intensity physical activity per week. The information sheet will also include links to publicly accessible online resources.

The intervention group will receive a behavioural change intervention, in addition to usual care. Information sheet about general guidelines on physical activity will be handed to the intervention group, as per control group. Each participant will receive up to 6 sessions of tailored behavioural change intervention during months 1 to 3 and there will be no intervention during months 4 to 6. Of the 6 sessions, 3 are face-to-face and another 3 will take place using telehealth methods such as phone, text messaging and videoconference. The tailoring of the intervention allows participants to decide the location during face-to-face sessions, how many sessions and how the sessions are spaced out during the 3-month intervention period and which sessions are face-to-face or telehealth. The preferred meeting location may include exercise spaces within home, common spaces just outside their homes and under their housing blocks, outdoor fitness zones or parks near home and residential or inclusive public gyms. The behavioural change intervention consists of physical activity counselling and prescription of a personalized physical activity plan. The first session will be conducted in-person, to allow the study physiotherapist to identify the participant's physical function, safety concerns and the impact of medical, social, environmental and resources on mobility. During the initial visit, the venue, frequency and mode of support (face-to-face or virtual) for subsequent sessions will be established. The study physiotherapist will provide physical activity counselling, set goals and discuss action plans to enhance moderate intensity physical activity, problem solve barriers on physical activity and prescribe a personalized physical activity plan. Subsequent sessions can include (1) training on physical activity modification to accommodate the weak arm and / leg at the participant's preferred exercise location, (2) taking videos of the personalized adapted exercises using the participant's phone when meeting face-to-face and (3) in-person or virtual support sessions to review physical activity progress and action plans.

A process and cost-utility evaluation will be embedded into the study design and conducted concurrently.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Singapore
    • Singapore
      • Singapore, Singapore, Singapore, 169608
        • Recruiting
        • Singapore General Hospital
        • Contact:
        • Principal Investigator:
          • Shamala Thilarajah, PhD
        • Sub-Investigator:
          • Yong Hao Pua, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged 21 years and over
  • Haemorrhagic or ischaemic stroke
  • At least 6 months post-stroke
  • Living at home
  • Able to walk independently +/- gait aid short distances (self-reported)
  • Have sufficient cognition and/or carer support to engage in the interventions (clinical judgement)
  • Agreement to undertake a supported self-management physical activity intervention programme

Exclusion Criteria:

  • Living in residential care
  • Unstable cardiac conditions, severe arthritis, or other conditions limiting the ability to exercise
  • Advised by GP/consultant not to undertake moderate-intensity exercise for health reason
  • Currently already participating in physical activity that meets recommended levels (150mins of moderate-vigorous physical activity)
  • Enrolled in another physical activity intervention trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group

Study period: 6 months (1st 3 months intervention, last 3 months no intervention) No. of sessions: up to 6 per participant Mode: 3 sessions are conducted face-to-face and 3 sessions via telehealth methods e.g. phone, text message or video conferencing using virtual platforms like zoom.

Where: Face-to-face at the participant's preferred exercise space like home, outdoor fitness zone, parks, gyms etc.

Duration of sessions: each face-to-face session will take 60-90 mins Details of intervention: Physical activity counselling on adaptation of exercises, goal setting, action planning, problem solving around barriers to physical activity and provision of study resources
Behavioral: Intervention group
Please refer to arm descriptions
Other Names:
  • MOTIVATE
Active Comparator: Control group
Study period: 6 months No. of sessions: 2 sessions (at month 1 and 3) Mode: Face-to-face Where: At the participant's home Duration of session: 20- 30 minutes Details of control: physical activity information without any other support.
Behavioral: Intervention group
Please refer to arm descriptions
Other Names:
  • MOTIVATE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of moderate to vigorous physical activity
Time Frame: Initial assessment (month 1), month 3 and 6 follow-up.
Average minutes/day, measured by Fitbit Inspire 3 tracker
Initial assessment (month 1), month 3 and 6 follow-up.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of steps per day
Time Frame: Initial assessment (month 1), month 3 and 6 follow-up.
Number of steps per day, measured by Fitbit Inspire 3 tracker
Initial assessment (month 1), month 3 and 6 follow-up.
International Physical Activity Questionnaire Short Form (IPAQ-SF)
Time Frame: Initial assessment (month 1), month 3 and 6 follow-up.
Duration (in minutes) and frequency (days) of walking, moderate-intensity, and vigorous-intensity activity, which are used to compute the total score.
Initial assessment (month 1), month 3 and 6 follow-up.
Modified Rankin Scale
Time Frame: Initial assessment (month 1), month 3 and 6 follow-up.

0. No symptoms

  1. No significant disability despite symptoms; able to carry out all usual duties and activities
  2. Slight disability: unable to carry out all previous activities but able to look after own affairs without assistance
  3. Moderate disability: requiring some help, but able to walk without assistance
  4. Moderately severe disability: unable to walk without assistance, and unable to attend to own bodily needs without assistance
  5. Severe disability: bedridden, incontinent, and requiring constant nursing care and attention

Outcome data: One score from a 6-point scale of 0-5.
Initial assessment (month 1), month 3 and 6 follow-up.
Functional Ambulation Category
Time Frame: Initial assessment (month 1), month 3 and 6 follow-up.

0) Patient cannot walk, or needs help from 2 or more persons

  1. Patients needs firm continuous support from 1 person who helps carrying weight and with balance
  2. Patient needs continuous or intermittent support of one person to help with balance and coordination
  3. Patient requires verbal supervision or stand-by help from one person without physical contact
  4. Patient can walk independently on level ground, but requires help on stairs, slopes or uneven surfaces
  5. Patient can walk independently anywhere

Outcome data: One score from a 6-point scale of 0-5
Initial assessment (month 1), month 3 and 6 follow-up.
Comfortable gait speed
Time Frame: Initial assessment (month 1), month 3 and 6 follow-up.
Comfortable walking speed equals to predetermined distance divided by the average time taken from 2 trials to walk that distance comfortably or naturally (e.g., 5m/__sec).
Initial assessment (month 1), month 3 and 6 follow-up.
Fast gait speed
Time Frame: Initial assessment (month 1), month 3 and 6 follow-up.
Fast walking speed equals to predetermined distance divided by the average time taken from 2 trials to walk that distance as fast as possibly safe (e.g., 5m/__sec).
Initial assessment (month 1), month 3 and 6 follow-up.
Life-space Assessment Measure
Time Frame: Initial assessment (month 1), month 3 and 6 follow-up.

For the five "Life-Space Levels," each "Yes" is given a point value, starting with 1 (life-space level 1) and increasing by 1 point for each life-space level (2 for "Yes" in life-space level 2, 3 for "Yes" in life-space level 3, etc.).

For frequency of each life-space level [less than 1 time per week (score = 1), 1-3 times per week (score = 2), 4-6 times per week (score = 3), or daily (score = 4)].

For independence level, requiring assistance or use of any equipment [personal assistance (score = 1), equipment only (score = 1.5), or neither equipment nor personal assistance (score = 2)].

Outcome data: The total score ranges from 0 ("totally bed-bound") to 120 ("traveling out of town every day without assistance").
Initial assessment (month 1), month 3 and 6 follow-up.
Fall Efficacy Scale International (FES-I)
Time Frame: Initial assessment (month 1), month 3 and 6 follow-up.

The Short FES-I consists of seven items

Each item is scored on a 4-point scale:

  1. Not concerned at all
  2. Somewhat concerned
  3. Fairly concerned
  4. Very concerned

Outcome data: Total score ranging from 7 (no concern about falling) to 28 (severe concern about falling).
Initial assessment (month 1), month 3 and 6 follow-up.
Self-Efficacy for Exercise Scale (SEES)
Time Frame: Initial assessment (month 1), month 3 and 6 follow-up.

Consists of 9 questions on the individual's confidence in their ability to engage in exercise. Each item is rated on a 11-point scale. Score of 0 indicates "not confident", and score of 10 indicates "very confident".

Outcome data: Total score ranges from 0 ("not confident" in own ability to engage in exercise) to 90 ("very confident" in own ability to engage in exercise)
Initial assessment (month 1), month 3 and 6 follow-up.
Fatigue Severity Scale - 7 item (FSS-7)
Time Frame: Initial assessment (month 1), month 3 and 6 follow-up.

The FSS-7 consists of seven items, and the responses are scored on a seven-point scale, where 1 indicates "strongly disagree" and 7 indicates "strongly agree."

Outcome data: Total score ranges from 7 to 49, with higher scores indicating more severe fatigue and greater impact on activities.
Initial assessment (month 1), month 3 and 6 follow-up.
Fatigue screening tool (SF-CAT)
Time Frame: Initial assessment (month 1), month 3 and 6 follow-up.
Yes/no screening questions to 16 questions that cover fatigue, mood, sleep quality, new / uncontrolled conditions, physical / nutrition status, role of medication consumption of alcohol, new / undiagnosed cognitive impairment, speech and language disorder.
Initial assessment (month 1), month 3 and 6 follow-up.
Depression and Anxiety (PHQ-4)
Time Frame: Initial assessment (month 1), month 3 and 6 follow-up.

The responses are scored on a four-point scale, where 0 indicates "not at all" and 3 indicates "nearly every day."

Outcome data: Total score ranges from 0 to 12, with higher scores indicating greater severity of depression and anxiety symptoms.
Initial assessment (month 1), month 3 and 6 follow-up.
Global Sleep Assessment Questionnaire (GSAQ)
Time Frame: Initial assessment (month 1), month 3 and 6 follow-up.

Consists of 11 questions, rated on a 4-point scale ("never", "sometimes", "usually", "always").

Outcome data: More "always" responses indicate better sleep quality.
Initial assessment (month 1), month 3 and 6 follow-up.
EQ-5D
Time Frame: Initial assessment (month 1), month 3 and 6 follow-up.
Outcome data: index values are used in the estimation of quality-adjusted life year (QALY) gains in economic analysis.
Initial assessment (month 1), month 3 and 6 follow-up.
Global Rating of Change on Physical Activity and Fatigue
Time Frame: Month 3 and 6 follow-up.

Score rated on a 15-point scale, ranging from -7 (a very great deal worse) to +7 (a very great deal better). A score of 0 indicates unchanged.

Outcome data: One score from the 15-point scale.
Month 3 and 6 follow-up.
Adapted Client Service Receipt Inventory (CSRI)
Time Frame: Initial assessment (month 1), month 3 and 6 follow-up.
Cost estimate of resource utilization to generate an average cost per participant
Initial assessment (month 1), month 3 and 6 follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Singapore General Hospital

Collaborators

Singapore Institute of Technology
National Neuroscience Institute

Investigators

  • Principal Investigator: Shamala Thilarajah, PhD, Singapore General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

May 7, 2024

First Submitted That Met QC Criteria

May 7, 2024

First Posted (Actual)

May 10, 2024

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/2015
  • 06/FY2023/P1/21-A36 (Other Grant/Funding Number: National Neuroscience Institute of Singapore Pte Ltd (NNI))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The study protocol with the statistical analysis plan will be published in a peer-reviewed journal.

IPD Sharing Time Frame

To be published ahead of the completion of the trial

IPD Sharing Access Criteria

The protocol will be available as per the publishing journal's options.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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