LEAP-MS Single-Arm Feasibility Study
Research type
Research Study
Full title
A Single-Arm Feasibility Study of the Life-Style Exercise and Activity Package for People Living with Progressive Multiple Sclerosis
IRAS ID
263430
Contact name
Monica Busse
Contact email
Sponsor organisation
Cardiff University
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 4 months, 28 days
Research summary
Research Summary
We know that many people with multiple sclerosis (MS) require support to remain physically active and often do not receive any or enough support. We know that this is particularly the case for People with Progressive MS (PwPMS) with moderate to severe disability – those who require assistance to mobilise (i.e. using a stick, frame or wheelchair) and/or have other MS related symptoms such as fatigue and difficulties remembering.Summary of Results
: People with advanced Multiple Sclerosis often struggle to access appropriate and inclusive support for regular physical activity. The Lifestyle, Exercise and Activity Package (LEAP-MS) intervention (https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.leapms.org%2F&data=04%7C01%7Capprovals%40hra.nhs.uk%7C3993614afe1349157be708da1d5d1456%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637854582844381249%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000&sdata=4FBFxr73ZN63Exi57RB3Rl8V8YF2hoFb2Q%2F5w4i7q84%3D&reserved=0) is a co-designed web-based physical activity intervention for People with advanced MS. It consists of two key components: (1) web-based coaching with physiotherapists using self-management support strategies to promote physical activity and 2) an interactive web-based platform including a physical activity information suite, an activity selection and planning tool and a participant-physiotherapist messaging system.
Our novel intervention encourages people with advanced MS to learn more about aspects of their condition and about physical activity via an information suite including advice from experts, short videos and reflections from peers. Through our ‘Activity Suite’ - an extensive library of activities, people using LEAP-MS are able to build their own bespoke programme of activity. The LEAP-MS platform provides a multitude of ideas for remaining physically active – not just traditional ‘exercises’- which have been selected or developed especially for people with advanced disability. As well as building their own plans, participants can set goals, log and monitor their progress.
Uniquely, the LEAP MS intervention has a paired account function in which people with MS can be paired with their NHS physiotherapist to respond to participants’ requests and to view participant activity and goal setting.
We tested the LEAP-MS intervention in a small study with 21 individuals with advanced MS who need assistance to walk or require a wheelchair to get around over a period of 12 weeks using an entirely remote (online) evaluation. The secure, encrypted multi-user web-based platform was accessible to both participants, physiotherapists and researchers with data input options via desktop computers, laptops, tablets or smart phones. Participants used the platform to register, complete eligibility forms, consent, baseline and follow -up measures and to access the intervention. Physiotherapists had access and editing permissions to review goals and activities and keep records.
After the intervention, 75% of participants reported improvements in their day-to-day activities as well as their mood and fatigue levels. Some improvements were maintained at 6 months. LEAP-MS provided people with advanced MS and physiotherapists with a new way of working in partnership. Both groups developed valuable skills in supported self-management by focussing on enhancing physical activity to support overall wellbeing. This study has laid the foundations for a large-scale evaluation of a co-designed intervention with potential for far reaching impact on the lives of people with advanced MS who are urgently in need.
In Phase 1 of the LEAP-MS study we collected information about the barriers to and facilitators of physical activity (PA) that PwPMS experience, their current levels and type of physical activity and their perceptions of the role physical activity plays in managing MS symptoms from both them and their families – or people that support them. This provided us with important information about why physical activity might be important for PwPMS, the challenges they face in doing physical activity or accessing it, and ways which they have found to overcome any barriers. We also collected information from physiotherapists who specialise in treating people with MS, about their understanding of self-management and their needs for training about using self-management approaches with PwPMS.
We used this information to co-produce (with the involvement of PwPMS patients and physiotherapists/healthcare professionals) a personalised intervention; Life-style, exercise and activity package for people living with progressive multiple sclerosis (LEAP-MS) to facilitate on-going physical activity for people with PwPMS and a training package about self-management with PwPMS for physiotherapists. The intervention is made up of face-face physiotherapy consultations and an online resource.
In this feasibility study we will evaluate the acceptability of the LEAP-MS intervention. We will also evaluate feasibility of conducting a future trial of the intervention in terms of recruitment, retention, adherence (usage), outcome measures and safety evaluation and establishing fidelity of intervention delivery.
REC name
Wales REC 6
REC reference
19/WA/0195
Date of REC Opinion
25 Jun 2019
REC opinion
Favourable Opinion