Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06409351
Status:
RECRUITING
Last Update Posted:
2024-05-10
First Post:
2024-05-07
Brief Title:
Multi-modal Training Program to Promote Physical Activity After Stroke
Sponsor:
Singapore General Hospital
Organization:
Singapore General Hospital
Study Overview
Official Title:
Multi-mOdal Training Program to Promote Physical actIVity After sTrokE MOTIVATE
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 11 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 participants 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 participants preferred exercise location 2 taking videos of the personalized adapted exercises using the participants 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
This trial will use a 11 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 participants 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 participants preferred exercise location 2 taking videos of the personalized adapted exercises using the participants 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06FY2023P121-A36 | OTHER_GRANT | National Neuroscience Institute of Singapore Pte Ltd NNI | None |