Life-Style Exercise and Activity Package for People Living With Progre
A Single-Arm Feasibility Study of the Life-Style Exercise and Activity Package for People Living With Progressive Multiple Sclerosis
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- LEAP-MS
What it measured
Main measures
Recruitment rate
6 months
Disability progressionSafetyFeasibilityRetention rate
6 months
FeasibilityIntervention uptake
6 months
Costs associated with intervention delivery
6 months
Incidence of Treatment-Emergent Adverse Events
6 months
SafetyAcceptability assessment (process evaluation)
6 months
FeasibilityFidelity of intervention delivery
6 months
Who could take part
Progressive MS · 18 and over
Show the full criteria
Inclusion criteria
* People aged 18 and over * With progressive MS * Having an Expanded Disability Status Scale (EDSS) score of 6, 6.5, 7, 7.5 or 8.
Exclusion criteria
* aged under 18 * an EDSS \<6 or >8 * relapsing-remitting or non-progressive MS * unable to understand written and spoken English * lacking capacity to consent on their own behalf * pregnant or planning a pregnancy
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The investigators know that many people with multiple sclerosis (MS) require support to remain physically active and often do not receive any or enough support. 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. In Phase 1 of the LEAP-MS study the investigators 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 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. The investigators also collected information from physiotherapists and other health care professionals 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. The investigators 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. In this feasibility study the investigators will evaluate the acceptability of the LEAP-MS intervention. The investigators 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.
Papers
Results
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.Trials · 2021
Results
Latchem-Hastings J, Randell E, Button K, Jones F, Lowe R, Dawes H, Wood F, Davies F, Poile V, O'Halloran R, Stensland B, Tallantyre E, Playle R, Edwards A, Busse M. Lifestyle, exercise and activity package for people living with progressive multiple sclerosis (LEAP-MS): protocol for a single-arm feasibility study. Pilot Feasibility Stud. 2021 May 22;7(1):111. doi: 10.1186/s40814-021-00852-w.
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History
Started
Aug 2020
Main results due
Apr 2021
Finished
Apr 2021