Clinical trial NCT06409351: Multi-modal Training Program to Promote Physical Activity After Stroke
Official title: Multi-mOdal Training Program to Promote Physical actIVity After sTrokE: MOTIVATE
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Physical Inactivity
Keywords: Physical activity
Behavioural change
Implementation Science
Stroke
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
Collaborators: name: Singapore Institute of Technology
name: National Neuroscience Institute
First posted: 2024-05-10
Enrollment: 120
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to either treatment or control group only during the duration of the study
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Duration of moderate to vigorous physical activity
timeFrame: Initial assessment (month 1), month 3 and 6 follow-up.
Secondary outcomes:
measure: Number of steps per day
timeFrame: Initial assessment (month 1), month 3 and 6 follow-up.
measure: International Physical Activity Questionnaire Short Form (IPAQ-SF)
timeFrame: Initial assessment (month 1), month 3 and 6 follow-up.
measure: Modified Rankin Scale
timeFrame: Initial assessment (month 1), month 3 and 6 follow-up.
measure: Functional Ambulation Category
timeFrame: Initial assessment (month 1), month 3 and 6 follow-up.
measure: Comfortable gait speed
timeFrame: Initial assessment (month 1), month 3 and 6 follow-up.
measure: Fast gait speed
timeFrame: Initial assessment (month 1), month 3 and 6 follow-up.
measure: Life-space Assessment Measure
timeFrame: Initial assessment (month 1), month 3 and 6 follow-up.
measure: Fall Efficacy Scale International (FES-I)
timeFrame: Initial assessment (month 1), month 3 and 6 follow-up.
measure: Self-Efficacy for Exercise Scale (SEES)
timeFrame: Initial assessment (month 1), month 3 and 6 follow-up.
measure: Fatigue Severity Scale - 7 item (FSS-7)
timeFrame: Initial assessment (month 1), month 3 and 6 follow-up.
measure: Fatigue screening tool (SF-CAT)
timeFrame: Initial assessment (month 1), month 3 and 6 follow-up.
measure: Depression and Anxiety (PHQ-4)
timeFrame: Initial assessment (month 1), month 3 and 6 follow-up.
measure: Global Sleep Assessment Questionnaire (GSAQ)
timeFrame: Initial assessment (month 1), month 3 and 6 follow-up.
measure: EQ-5D
timeFrame: Initial assessment (month 1), month 3 and 6 follow-up.
measure: Global Rating of Change on Physical Activity and Fatigue
timeFrame: Month 3 and 6 follow-up.
measure: Adapted Client Service Receipt Inventory (CSRI)
timeFrame: Initial assessment (month 1), month 3 and 6 follow-up.
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: Singapore General Hospital
name: Shamala Thilarajah, PhD
role: PRINCIPAL_INVESTIGATOR
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