NCT03951181: LEAP-MS

Life-Style Exercise and Activity Package for People Living With Progressive MS

Completed NA Last updated 2 July 2021

What this trial tests

NA trial testing LEAP-MS in Multiple Sclerosis in 21 participants. Completed in 19 April 2021.

Timeline

13 August 2020

Primary endpoint
19 April 2021

19 April 2021

Quick facts

Lead sponsor	Cardiff University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	21
Start date	13 August 2020
Primary completion	19 April 2021
Estimated completion	19 April 2021
Sites	1 location across United Kingdom

Drugs / interventions tested

• LEAP-MS

Conditions studied

• Multiple Sclerosis — all drugs for Multiple Sclerosis →

Sponsor

Cardiff University

Who can join

18 and older, any sex, with Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Lowe R, Barlow C, Lloyd B, Latchem-Hastings J, et al · · 2021 · cited 14× · PMID 33863342 · DOI 10.1186/s13063-021-05245-1
2. Web-based physical activity intervention for people with progressive multiple sclerosis: application of consensus-based intervention development guidance.
   Busse M, Latchem-Hastings J, Button K, Poile V, et al · · 2021 · cited 8× · PMID 33727274 · DOI 10.1136/bmjopen-2020-045378
3. Lifestyle, exercise and activity package for people living with progressive multiple sclerosis (LEAP-MS): protocol for a single-arm feasibility study.
   Latchem-Hastings J, Randell E, Button K, Jones F, et al · · 2021 · cited 5× · PMID 34022955 · DOI 10.1186/s40814-021-00852-w
4. Lifestyle, exercise and activity package for people living with progressive multiple sclerosis (LEAP-MS): Protocol for a Single-Arm Feasibility Study.
   Latchem-Hastings J, Randell E, Button K, Jones F, et al · · 2020 · DOI 10.21203/rs.3.rs-30578/v1