scholarly journals Safety, feasibility, acceptability and effects of a behaviour-change intervention to change physical activity behaviour among people with multiple sclerosis: Results from the iStep-MS randomised controlled trial

2019 ◽  
Vol 26 (14) ◽  
pp. 1907-1918 ◽  
Author(s):  
Jennifer M Ryan ◽  
Jennifer Fortune ◽  
Andrea Stennett ◽  
Cherry Kilbride ◽  
Grace Lavelle ◽  
...  

Background: There is limited information regarding the safety, feasibility and acceptability of behaviour-change interventions to increase physical activity (PA) and reduce sedentary behaviour among people with multiple sclerosis (MS). Prior to evaluating efficacy, it is important to identify problems with feasibility and acceptability, which may undermine effectiveness. Objective: To examine the safety, feasibility and acceptability of a behaviour-change intervention to increase PA and reduce sedentary behaviour among people with MS. Methods: Sixty people received a 3-month intervention or usual care. Fatigue, pain and adverse events (AEs) were assessed. Feasibility and acceptability were explored through focus groups with physiotherapists and interviews with participants. Fidelity to intervention content, delivery skills, programme receipt and programme task were assessed. Results: There was no difference in AE rate between groups ( p = 0.965). Fatigue and pain were not higher in the intervention group at 3 or 9 months. Therapists reported the intervention was feasible to deliver and fidelity was acceptable. Twenty-nine participants (97%) attended at least 75% of sessions. Participants found the intervention acceptable but suggested some amendments were required to intervention components. Conclusions: The intervention was safe, feasible and acceptable. Although modifications are required to intervention components, the intervention warrants further evaluation in a future trial.

BMJ Open ◽  
2020 ◽  
Vol 10 (3) ◽  
pp. e029831 ◽  
Author(s):  
Jennifer Fortune ◽  
Meriel Norris ◽  
Andrea Stennett ◽  
Cherry Kilbride ◽  
Grace Lavelle ◽  
...  

ObjectivesThe purpose of this study was to explore the experiences of people with multiple sclerosis (MS) who participated in iStep-MS, a feasibility randomised controlled trial of a behaviour change intervention that aimed to increase physical activity and reduce sedentary behaviour.DesignA qualitative approach was undertaken embedded in the feasibility randomised controlled trial. One-to-one semi-structured interviews were conducted and analysed using Framework analysis.SettingParticipants were recruited from a single MS therapy centre in the southeast of England, UK.ParticipantsSixty people with MS were randomly allocated in a 1:1 ratio to the intervention or usual care. Following a purposive sampling strategy, 15 participants from the intervention arm undertook 1:1 semi-structured interviews.InterventionsThe iStep-MS intervention consisted of four therapist-led sessions over 12 weeks, supported by a handbook and pedometer.ResultsThree themes were identified from the data.“I can do this”: developing competence in physical activityhighlights the enhanced physical activity confidence gained through goal setting and accomplishment. “I felt valued”: the nurturing cultureprovides an overview of the supportive and non-judgemental environment created by the programme structure and therapeutic relationship. Finally, “What can I do?”: empowered enactmentdescribes the transition from the supported iStep-MS intervention to intrinsically motivated physical activity enactment.ConclusionsOverall, this study supports the acceptability of the iStep-MS intervention and identified key areas that supported participants to be physically active.Trial registration numberISRCTN15343862.


Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Farren L. Goulding ◽  
Charity D. Evans ◽  
Katherine B. Knox ◽  
Hyun J. Lim ◽  
Michael C. Levin ◽  
...  

Abstract Background Multiple sclerosis (MS) is a chronic, degenerative disease of the central nervous system. Because of the long-term and unpredictable nature of the disease, the burden of MS is significant from both a patient and societal perspective. Despite a recent influx of disease-modifying therapies to treat MS, many individuals continue to experience disability that negatively affects productivity and quality of life. Previous research indicates that physical activity has a positive impact on walking function in individuals with MS, in addition to the usual beneficial effects on overall health. However, most people with MS are not active enough to gain these benefits, and a lack of support to initiate and maintain physical activity has been identified as a major barrier. This study will evaluate the impact of a novel intervention involving individualised behaviour change strategies delivered by neurophysiotherapists on increasing physical activity levels in individuals with MS who are currently inactive. Methods/design This single-blind, parallel-group, randomised controlled trial will be conducted in Saskatchewan, Canada. Eligible participants include individuals with MS who are ambulatory but identified as currently inactive by the self-reported Godin Leisure-Time Exercise Questionnaire (GLTEQ). The intervention will be delivered by neurophysiotherapists and includes individualised behaviour change strategies aimed at increasing physical activity over a 12-month period. The control group will receive usual care during the 12-month study period. The primary outcome is the change in physical activity level, as measured by the change in the GLTEQ score from baseline to 12 months. Secondary outcomes include the change in patient-reported outcome measures assessing MS-specific symptoms, confidence and quality of life. Discussion Physical activity has been identified as a top research priority by the MS community. Findings from this novel study may result in new knowledge that could significantly impact the management and overall health of individuals with MS. Trial registration ClinicalTrials.gov, NCT04027114. Registered on 10 July 2019.


BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e040479
Author(s):  
Kacie Patterson ◽  
Rachel Davey ◽  
Richard Keegan ◽  
Theophile Niyonsenga ◽  
Itismita Mohanty ◽  
...  

IntroductionCardiac rehabilitation (CR) is recommended for secondary prevention of cardiovascular disease and reducing the risk of repeat cardiac events. Physical activity is a core component of CR; however, studies show that participants remain largely sedentary. Sedentary behaviour is an independent risk factor for all-cause mortality. Strategies to encourage sedentary behaviour change are needed. This study will explore the effectiveness and costs of a smartphone application (Vire) and an individualised online behaviour change program (ToDo-CR) in reducing sedentary behaviour, all-cause hospital admissions and emergency department visits over 12 months after commencing CR.Methods and analysisA multicentre, assessor-blind parallel randomised controlled trial will be conducted with 144 participants (18+ years). Participants will be recruited from three phase-II CR centres. They will be assessed on admission to CR and randomly assigned (1:1) to one of two groups: CR plus the ToDo-CR 6-month programme or usual care CR. Both groups will be re-assessed at 6 months and 12 months for the primary outcome of all-cause hospital admissions and presentations to the emergency department. Accelerometer-measured changes in sedentary behaviour and physical activity will also be assessed. Logistic regression models will be used for the primary outcome of hospital admissions and emergency department visits. Methods for repeated measures analysis will be used for all other outcomes. A cost-effectiveness analysis will be conducted to evaluate the effects of the intervention on the rates of hospital admissions and emergency department visits within the 12 months post commencing CR.Ethics and disseminationThis study received ethical approval from the Australian Capital Territory Health (2019.ETH.00162), Calvary Public Hospital Bruce (20–2019) and the University of Canberra (HREC-2325) Human Research Ethics Committees (HREC). Results will be disseminated through peer-reviewed academic journals. Results will be made available to participants on request.Trial registration numberACTRN12619001223123.


Sign in / Sign up

Export Citation Format

Share Document