Mobile health to promote physical activity in people post stroke or transient ischemic attack - study protocol for a feasibility randomised controlled trial

Charlotte Thurston; Lucian Bezuidenhout; Sophia Humphries; Sverker Johansson; Lena von Koch; Charlotte K Häger; Lisa Holmlund; Carl Johan Sundberg; Sara Garcia-Ptacek; Lydia Kwak; Michael Nilsson; Coralie English; David Moulaee Conradsson

doi:10.1186/s12883-023-03163-0

Mobile health to promote physical activity in people post stroke or transient ischemic attack - study protocol for a feasibility randomised controlled trial

BMC Neurol. 2023 Mar 28;23(1):124. doi: 10.1186/s12883-023-03163-0.

Authors

Charlotte Thurston¹, Lucian Bezuidenhout¹, Sophia Humphries¹, Sverker Johansson^{1

2}, Lena von Koch^{3

4}, Charlotte K Häger⁵, Lisa Holmlund⁶, Carl Johan Sundberg^{7

8}, Sara Garcia-Ptacek^{9

10}, Lydia Kwak¹¹, Michael Nilsson^{12

13

14

15}, Coralie English^#^{12

13

14}, David Moulaee Conradsson^#^{16

17}

Affiliations

¹ Department of Neurobiology, Care Sciences and Society, Division of Physiotherapy, Karolinska Institutet, 23100, Stockholm, Sweden.
² Women's Health and Allied Health Professionals Theme, Medical Unit Occupational Therapy and Physiotherapy, Karolinska University Hospital, Stockholm, Sweden.
³ Department of Neurobiology, Care Science and Society, Division of Family Medicine and Primary Care, Karolinska Institutet, Stockholm, Sweden.
⁴ Theme Heart & Vascular and Neuro, Karolinska University Hospital, Stockholm, Sweden.
⁵ Department of Community Medicine and Rehabilitation - Physiotherapy Section, Umeå University, Umeå, Sweden.
⁶ Department of Neurobiology, Care Science and Society, Division of Occupational Therapy, Karolinska Institutet, Stockholm, Sweden.
⁷ Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden.
⁸ Department of Learning, Informatics, Management and Ethics, Karolinska Institutet, Stockholm, Sweden.
⁹ Department of Neurobiology, Care Sciences and Society, Center for Alzheimer Research, Division of Clinical Geriatrics, Karolinska Institutet, Stockholm, Sweden.
¹⁰ Theme Inflammation and Aging, Karolinska University Hospital, Stockholm, Sweden.
¹¹ Institute of Environmental Medicine, Unit of Intervention and Implementation Research for Worker Health, Karolinska Institutet, Stockholm, Sweden.
¹² Heart and Stroke Research Program, Hunter Medical Research Institute, Newcastle, NSW, Australia.
¹³ Centre for Research Excellence in Stroke Recovery and Rehabilitation, Florey Institute of Neuroscience and Mental Health, Melbourne, VIC, Australia.
¹⁴ The Centre for Rehab Innovations (CRI), College of Health, Medicine and Wellbeing, University of Newcastle, Newcastle, Australia.
¹⁵ Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, Singapore.
¹⁶ Department of Neurobiology, Care Sciences and Society, Division of Physiotherapy, Karolinska Institutet, 23100, Stockholm, Sweden. david.m.conradsson@ki.se.
¹⁷ Women's Health and Allied Health Professionals Theme, Medical Unit Occupational Therapy and Physiotherapy, Karolinska University Hospital, Stockholm, Sweden. david.m.conradsson@ki.se.

^# Contributed equally.

Abstract

Background: Physical activity is essential to improve health and reduce the risk of recurrence of stroke or transient ischemic attack (TIA). Still, people post stroke or TIA are often physically inactive and the availability of physical activity promotion services are often limited. This study builds on an existing Australian telehealth-delivered programme (i-REBOUND- Let's get moving) which provides support for home-based physical activity for people post stroke or TIA. The aim of this study is to test the feasibility, acceptability, and preliminary effects of a mobile Health (mHealth) version of the i-REBOUND programme for the promotion of physical activity in people post stroke or TIA living in Sweden.

Methods: One hundred and twenty participants with stroke or TIA will be recruited via advertisement. A parallel-group feasibility randomised controlled trial design with a 1:1 allocation ratio to 1) i-REBOUND programme receiving physical exercise and support for sustained engagement in physical activity through behavioural change techniques, or 2) behavioural change techniques for physical activity. Both interventions will proceed for six months and be delivered digitally through a mobile app. The feasibility outcomes (i.e., reach, adherence, safety and fidelity) will be monitored throughout the study. Acceptability will be assessed using the Telehealth Usability Questionnaire and further explored through qualitative interviews with a subset of both study participants and the physiotherapists delivering the intervention. Clinical outcomes on preliminary effects of the intervention will include blood pressure, engagement in physical activity, self-perceived exercise self-efficacy, fatigue, depression, anxiety, stress and health-related quality of life and will be measured at baseline and at 3, 6 and 12 months after the baseline assessments.

Discussion: We hypothesise that the mHealth delivery of the i-REBOUND programme will be feasible and acceptable in people post stroke/TIA living in rural and urban regions of Sweden. The results of this feasibility trial will inform the development of full-scale and appropriately powered trial to test the effects and costs of mHealth delivered physical activity for people after stroke or TIA.

Trial registration: ClinicalTrials.gov Identifier: NCT05111951. Registered November 8, 2021.

Keywords: Behaviour change; Complex interventions; E-Health; Feasibility; Physical exercise; Secondary prevention.

Publication types

Clinical Trial Protocol

MeSH terms

Australia
Exercise
Feasibility Studies
Humans
Ischemic Attack, Transient*
Quality of Life
Randomized Controlled Trials as Topic
Stroke*

Associated data

ClinicalTrials.gov/NCT05111951

Abstract

Publication types

MeSH terms

Associated data

Grants and funding