Multi-modal Training Program to Promote Physical Activity After Stroke
NCT ID: NCT06409351
Last Updated: 2024-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
120 participants
INTERVENTIONAL
2024-06-11
2026-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Does High-intensity Exercise Lead to Better Functional Outcomes Early After Stroke in an Inpatient Rehabilitation Setting?
NCT06913127
Efficacy of Task-specific Training on Physical Activity Levels Post-stroke
NCT02937480
Exercise Training and Walking Ability After Chronic Stroke
NCT00107068
A Novel Ballet-inspired Low-impact At-home Workout Programme for Adults with Stroke
NCT04460794
Rehabilitation Training Participated by Caregivers in Ischemic Stroke: a Randomized Controlled Trial to Test the Effect of Home-based Rehabilitation Intervention on Physical Function.
NCT06186739
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
Intervention group
Please refer to arm descriptions
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.
Intervention group
Please refer to arm descriptions
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Intervention group
Please refer to arm descriptions
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
21 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Singapore Institute of Technology
OTHER
National Neuroscience Institute
OTHER
Singapore General Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Shamala Thilarajah, PhD
Role: PRINCIPAL_INVESTIGATOR
Singapore General Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Singapore General Hospital
Singapore, , Singapore
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Hardie K, Hankey GJ, Jamrozik K, Broadhurst RJ, Anderson C. Ten-year risk of first recurrent stroke and disability after first-ever stroke in the Perth Community Stroke Study. Stroke. 2004 Mar;35(3):731-5. doi: 10.1161/01.STR.0000116183.50167.D9. Epub 2004 Feb 5.
Turan TN, Nizam A, Lynn MJ, Egan BM, Le NA, Lopes-Virella MF, Hermayer KL, Harrell J, Derdeyn CP, Fiorella D, Janis LS, Lane B, Montgomery J, Chimowitz MI. Relationship between risk factor control and vascular events in the SAMMPRIS trial. Neurology. 2017 Jan 24;88(4):379-385. doi: 10.1212/WNL.0000000000003534. Epub 2016 Dec 21.
Fini NA, Bernhardt J, Said CM, Billinger SA. How to Address Physical Activity Participation After Stroke in Research and Clinical Practice. Stroke. 2021 Jun;52(6):e274-e277. doi: 10.1161/STROKEAHA.121.034557. Epub 2021 May 6. No abstract available.
WHO Guidelines on Physical Activity and Sedentary Behaviour. Geneva: World Health Organization; 2020. Available from http://www.ncbi.nlm.nih.gov/books/NBK566045/
Billinger SA, Arena R, Bernhardt J, Eng JJ, Franklin BA, Johnson CM, MacKay-Lyons M, Macko RF, Mead GE, Roth EJ, Shaughnessy M, Tang A; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Lifestyle and Cardiometabolic Health; Council on Epidemiology and Prevention; Council on Clinical Cardiology. Physical activity and exercise recommendations for stroke survivors: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014 Aug;45(8):2532-53. doi: 10.1161/STR.0000000000000022. Epub 2014 May 20.
Thilarajah S, Bower KJ, Pua YH, Tan D, Williams G, Larik A, Bok CW, Koh G, Clark RA. Modifiable Factors Associated With Poststroke Physical Activity at Discharge From Rehabilitation: Prospective Cohort Study. Phys Ther. 2020 May 18;100(5):818-828. doi: 10.1093/ptj/pzaa022.
Fini NA, Holland AE, Keating J, Simek J, Bernhardt J. How Physically Active Are People Following Stroke? Systematic Review and Quantitative Synthesis. Phys Ther. 2017 Jul 1;97(7):707-717. doi: 10.1093/ptj/pzx038.
Thilarajah S, Mentiplay BF, Bower KJ, Tan D, Pua YH, Williams G, Koh G, Clark RA. Factors Associated With Post-Stroke Physical Activity: A Systematic Review and Meta-Analysis. Arch Phys Med Rehabil. 2018 Sep;99(9):1876-1889. doi: 10.1016/j.apmr.2017.09.117. Epub 2017 Oct 19.
Moncion K, Biasin L, Jagroop D, Bayley M, Danells C, Mansfield A, Salbach NM, Inness E, Tang A. Barriers and Facilitators to Aerobic Exercise Implementation in Stroke Rehabilitation: A Scoping Review. J Neurol Phys Ther. 2020 Jul;44(3):179-187. doi: 10.1097/NPT.0000000000000318.
Committee for Proprietary Medicinal Products. Points to consider on switching between superiority and non-inferiority. Br J Clin Pharmacol. 2001 Sep;52(3):223-8. doi: 10.1046/j.0306-5251.2001.01397-3.x. No abstract available.
Yarnell CJ, Abrams D, Baldwin MR, Brodie D, Fan E, Ferguson ND, Hua M, Madahar P, McAuley DF, Munshi L, Perkins GD, Rubenfeld G, Slutsky AS, Wunsch H, Fowler RA, Tomlinson G, Beitler JR, Goligher EC. Clinical trials in critical care: can a Bayesian approach enhance clinical and scientific decision making? Lancet Respir Med. 2021 Feb;9(2):207-216. doi: 10.1016/S2213-2600(20)30471-9. Epub 2020 Nov 20.
Chang BH, Pocock S. Analyzing data with clumping at zero. An example demonstration. J Clin Epidemiol. 2000 Oct;53(10):1036-43. doi: 10.1016/s0895-4356(00)00223-7.
Thorn JC, Coast J, Cohen D, Hollingworth W, Knapp M, Noble SM, Ridyard C, Wordsworth S, Hughes D. Resource-use measurement based on patient recall: issues and challenges for economic evaluation. Appl Health Econ Health Policy. 2013 Jun;11(3):155-61. doi: 10.1007/s40258-013-0022-4.
Hodgson TA. Costs of illness in cost-effectiveness analysis. A review of the methodology. Pharmacoeconomics. 1994 Dec;6(6):536-52. doi: 10.2165/00019053-199406060-00007.
Stinnett AA, Mullahy J. Net health benefits: a new framework for the analysis of uncertainty in cost-effectiveness analysis. Med Decis Making. 1998 Apr-Jun;18(2 Suppl):S68-80. doi: 10.1177/0272989X98018002S09.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
06/FY2023/P1/21-A36
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2024/2015
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.