Multi-modal Training Program to Promote Physical Activity After Stroke

NCT06409351 | Recruiting DMC

• 2 other identifiers: 2024/201506/FY2023/P1/21-A36
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Physical Inactivity

Keywords

Physical activity; Behavioural change; Implementation Science; Stroke

Outcome Measures

Primary Outcomes (1)

• Duration of moderate to vigorous physical activity

  Average minutes/day, measured by Fitbit Inspire 3 tracker

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

Secondary Outcomes (16)

• Number of steps per day

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

• International Physical Activity Questionnaire Short Form (IPAQ-SF)

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

• Modified Rankin Scale

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

• Functional Ambulation Category

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

• Comfortable gait speed

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

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

Intervention group BEHAVIORAL

Please refer to arm descriptions

Also known as: MOTIVATE

Control group; Intervention group

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Singapore General Hospital: lead
• Singapore Institute of Technology: collaborator
• National Neuroscience Institute: collaborator

Study Sites (1)

Singapore General Hospital

Singapore, Singapore, 169608, Singapore

RECRUITING

Related Publications (15)

• 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.

  PMID: 14764929 BACKGROUND

• 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.

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• 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.

  PMID: 33951930 BACKGROUND

• WHO Guidelines on Physical Activity and Sedentary Behaviour. Geneva: World Health Organization; 2020. Available from http://www.ncbi.nlm.nih.gov/books/NBK566045/

  PMID: 33369898 BACKGROUND

• 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.

  PMID: 24846875 BACKGROUND

• 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.

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• 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.

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• 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.

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• 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.

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MeSH Terms

Conditions

Stroke; Sedentary Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Shamala Thilarajah, PhD

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juliana Wang, MSc

CONTACT

+6597124823; juliana.wang.y.y@sgh.com.sg

Shamala Thilarajah, PhD

CONTACT

+6591160364; shamala.thilarajah@sgh.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Only the outcomes assessor is masked. No other parties are masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are assigned to either treatment or control group only during the duration of the study

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 10, 2024
• Study Start: June 11, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: To be published ahead of the completion of the trial
• Access Criteria: The protocol will be available as per the publishing journal's options.

Locations

SG (1)