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Published in: Trials 1/2021

Open Access 01-12-2021 | Multiple Sclerosis | Commentary

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

Authors: Rachel Lowe, Christy Barlow, Barry Lloyd, Julie Latchem-Hastings, Vincent Poile, Charlotte Scoble, Andrew Dean-Young, Kate Button, Rebecca Playle, Monica Busse

Published in: Trials | Issue 1/2021

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Abstract

The LEAP-MS (Lifestyle, Exercise and Activity Package for People living with Progressive Multiple Sclerosis) study has developed an individualised supported self-management approach for physical activity for people with progressive multiple sclerosis (MS) and severe disability. The intervention has been evaluated in a single-arm feasibility study with embedded process evaluation. The feasibility study was due to open to recruitment during the COVID-19 2020–2021 pandemic, 1 month into the first UK-wide lockdown. We worked rapidly to implement adaptions to the trial procedures and intervention delivery that we believe are applicable to randomised controlled trials.
Recruitment became predominantly via self-referral. Electronic consent was employed, with consent discussions occurring over the telephone. Registration, consent, eligibility assessment and data collection as well as the intervention (online physical activity tool) were via a secure, encrypted multi-user web-based platform for participants, physiotherapists and researchers accessible via various hardware. Physiotherapy consultations, as well as the process evaluation, were conducted remotely using video conferencing software or the telephone. A remote training package for physiotherapists and site initiations was also developed and electronic site files employed.
Our adaptions are extremely topical given the COVID-19 situation, and whilst not what we had originally planned, have enabled successful delivery of the feasibility study and are relevant to conducting randomised controlled trials and meeting the needs of people with MS who are far more isolated than ever before.

Trial registration

ClinicalTrials.​govNCT03951181. Registered on 15 May 2019.
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Metadata
Title
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
Authors
Rachel Lowe
Christy Barlow
Barry Lloyd
Julie Latchem-Hastings
Vincent Poile
Charlotte Scoble
Andrew Dean-Young
Kate Button
Rebecca Playle
Monica Busse
Publication date
01-12-2021
Publisher
BioMed Central
Published in
Trials / Issue 1/2021
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-021-05245-1

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