Lifestyle, exercise and activity package for people living with progressive multiple sclerosis (LEAP-MS): Protocol for a Single-Arm Feasibility Study.

Abstract

Background. We have co-designed a tailored blended physiotherapy intervention for people with Progressive Multiple Sclerosis (MS) who often struggle to access support for physical activity. Underpinned by self-management principles, the Lifestyle, Exercise and Activity Package for people with MS intervention, which we call the LEAP-MS intervention, incorporates face-to-face or online physiotherapy coaching sessions with an accompanying online physical activity platform. The LEAP-MS platform is a multi-user system enabling user and physiotherapist to co-create activity plans. The LEAP-MS platform consists of an information and activity suite, interactive components enabling selection of exercises into an activity programme, goal setting, and activity logging. The platform also facilitates online remote support from a physiotherapist through an embedded online messaging function. We aim to evaluate the LEAP-MS platform in a feasibility trial. Methods. LEAP-MS will be evaluated within a single arm feasibility study with embedded process evaluation. After registration and initial eligible screening, 21 participants will be required to complete baseline self-completion measures. This will be followed by an initial home-based or online coaching session with a physiotherapist (who has received tailored self-management and digital resource training) and access to the online intervention for an initial three-month period. During this period participants are given the option to request up to five further home-based or online physiotherapy coaching sessions. Follow-up questionnaires and semi-structured interviews will be administered three months after baseline with participants and intervention physiotherapists. The LEAP-MS platform will be available to participants for a further three months. Usage of the LEAP-MS platform will be tracked during the full six-month period and final follow up will be conducted six months after baseline. Discussion. Feasibility outcomes (recruitment, retention, intervention uptake and safety) will be reported. The process evaluation will be undertaken to identify possible mechanisms for any observed effects. The data here will inform full scale evaluations of this co-produced, blended physiotherapy intervention. Trial registration: ClinicalTrials.gov NCT03951181. Registered 15th May 2019 https://clinicaltrials.gov/ct2/show/NCT03951181

Web-based physical activity intervention for people with progressive multiple sclerosis: application of consensus-based intervention development guidance

“…A bespoke LEAP-MS training package 43 which ensures skill development in provision of self-management support skills for physiotherapist 42 alongside the appropriate use of technology in coaching sessions and application of physical activity and exercise guidelines for neurological conditions has been developed. 44 The initial content was achieved through the conduct of a 2 day interactive training session, attended by physiotherapists likely to deliver the intervention in the subsequent evaluation, underpinned by Bridges Self-Management principles and delivered by Bridges Social Enterprise ( http://www.bridgesselfmanagement.org.uk/ ).…”

“…In line with the Medical Research Council Framework for Development and Evaluation of complex interventions, 48 49 LEAP-MS will be evaluated within a single arm feasibility study with embedded process evaluation. 43 After registration and initial eligible screening, 21 participants will be required to complete baseline self-report measures after which they will be able to access the intervention for an initial 3-month period. During this period, participants are given the option to request up to five further home-based or online physiotherapy coaching sessions as found acceptable in previous physical activity interventions using components of this intervention.…”

Impact of the COVID-19 Pandemic on Physical Activity and Associated Technology Use in Persons With Multiple Sclerosis: An International RIMS-SIG Mobility Survey Study

“…The Lifestyle, Exercise, and Activity Package for People Living With Progressive Multiple Sclerosis study is an example of good practice in public patient involvement in intervention and trial design. 37…”

Lifestyle, Exercise and Activity Package for People living with Progressive Multiple Sclerosis (LEAP-MS): adaptions during the COVID-19 pandemic and remote delivery for improved efficiency

“…We sought to evaluate the feasibility and acceptability of the intervention and trial procedures in a single-arm feasibility study with embedded process evaluation [ 21 ]. The study was due to open to recruitment in April 2020, 1 month into the first UK wide lockdown during the COVID-19 2020–2021 pandemic [ 22 ].…”

“…Given the impending start of recruitment we worked rapidly to implement amendments and succeeded in securing a 6-month no-cost extension from the funder (MS Society). The following amendments to the feasibility study protocol were classed as non-substantial amendments under the guidance issued by the Health Research Authority [ 36 ] and the revised protocol was submitted for publication (currently under review) [ 21 ].…”