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NCT Number: NCT06409351

Multi-modal Training Program to Promote Physical Activity After Stroke

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.

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Key information

Conditions

Stroke Behavior Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Motor Activity Nervous System Diseases Physical Inactivity Sedentary Behavior Vascular Diseases

Age range

21 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Singapore General Hospital

Singapore, 169608

Location status: Recruiting

Location contact

Juliana Wang, MSc

CONTACT

[email protected]

+6597124823

Shamala Thilarajah, PhD

PRINCIPAL_INVESTIGATOR

Yong Hao Pua, PhD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention Group

Behavioral

Please refer to arm descriptions

Other names: MOTIVATE

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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.

  3. Modified Rankin Scale

    Time frame: Initial assessment (month 1), month 3 and 6 follow-up.

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

    Outcome data: One score from a 6-point scale of 0-5.

  4. Functional Ambulation Category

    Time frame: Initial assessment (month 1), month 3 and 6 follow-up.

    • Patient cannot walk, or needs help from 2 or more persons
    • Patients needs firm continuous support from 1 person who helps carrying weight and with balance
    • Patient needs continuous or intermittent support of one person to help with balance and coordination
    • Patient requires verbal supervision or stand-by help from one person without physical contact
    • Patient can walk independently on level ground, but requires help on stairs, slopes or uneven surfaces
    • Patient can walk independently anywhere

    Outcome data: One score from a 6-point scale of 0-5

  5. 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).

  6. 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).

  7. 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").

  8. 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:

    • Not concerned at all
    • Somewhat concerned
    • Fairly concerned
    • Very concerned

    Outcome data: Total score ranging from 7 (no concern about falling) to 28 (severe concern about falling).

  9. 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)

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Juliana Wang, MSc

CONTACT

[email protected]

+6597124823

Shamala Thilarajah, PhD

CONTACT

[email protected]

+6591160364

Sponsors and collaborators

Lead sponsor

Singapore General Hospital

Other

Collaborators

  • National Neuroscience Institute
  • Singapore Institute of Technology

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
May 10, 2024
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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