A Single-Arm Feasibility Study of the Life-Style Exercise and Activity Package for People Living With Progressive Multiple Sclerosis

CompletedNot a drug-phase studyProgressive MSNCT03951181

What it found

Paper found, not read

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 progressionSafetyFeasibility
  • Retention rate

    6 months

    Feasibility
  • Intervention uptake

    6 months

  • Costs associated with intervention delivery

    6 months

  • Incidence of Treatment-Emergent Adverse Events

    6 months

    Safety
  • Acceptability assessment (process evaluation)

    6 months

    Feasibility
  • Fidelity 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

Loading reviews and guidelines…

History

    1. Started

      Aug 2020

    2. Main results due

      Apr 2021

    3. Finished

      Apr 2021

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