Multi-modal Training Program to Promote Physical Activity After Stroke

Official title

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

Overview

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.

Interventions

• Behavioral Intervention group
  Please refer to arm descriptions

Primary outcome measures

• Duration of moderate to vigorous physical activity [Time frame: Initial assessment (month 1), month 3 and 6 follow-up.]

Secondary outcome measures (12)

• Number of steps per day [Time frame: Initial assessment (month 1), month 3 and 6 follow-up.]
• International Physical Activity Questionnaire Short Form (IPAQ-SF) [Time frame: Initial assessment (month 1), month 3 and 6 follow-up.]
• Modified Rankin Scale [Time frame: Initial assessment (month 1), month 3 and 6 follow-up.]
• Functional Ambulation Category [Time frame: Initial assessment (month 1), month 3 and 6 follow-up.]
• Comfortable gait speed [Time frame: Initial assessment (month 1), month 3 and 6 follow-up.]
• Fast gait speed [Time frame: Initial assessment (month 1), month 3 and 6 follow-up.]
• Life-space Assessment Measure [Time frame: Initial assessment (month 1), month 3 and 6 follow-up.]
• Fall Efficacy Scale International (FES-I) [Time frame: Initial assessment (month 1), month 3 and 6 follow-up.]
• Self-Efficacy for Exercise Scale (SEES) [Time frame: Initial assessment (month 1), month 3 and 6 follow-up.]
• Fatigue Severity Scale - 7 item (FSS-7) [Time frame: Initial assessment (month 1), month 3 and 6 follow-up.]
• Fatigue screening tool (SF-CAT) [Time frame: Initial assessment (month 1), month 3 and 6 follow-up.]
• Depression and Anxiety (PHQ-4) [Time frame: Initial assessment (month 1), month 3 and 6 follow-up.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Singapore · 1 center

• Singapore General Hospital — Singapore

Publications

• 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
• 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. PMID 28003500
• 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
• 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
• 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 str PMID 24846875
• 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. PMID 31995190
• 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. PMID 28444348
• 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. PMID 29056502

Identifiers

NCT: NCT06409351 · 2024/2015 · 06/FY2023/P1/21-A36

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗