Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03951181
Recruitment Status : Active, not recruiting
First Posted : May 15, 2019
Last Update Posted : March 4, 2021
Sponsor:
Information provided by (Responsible Party):
Cardiff University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: LEAP-MS Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Single-Arm Feasibility Study of the Life-Style Exercise and Activity Package for People Living With Progressive Multiple Sclerosis
Actual Study Start Date : August 13, 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LEAP-MS Intervention
This is a single arm study.
Behavioral: LEAP-MS
The LEAP-MS intervention is a co-produced, digital interactive education and activity tool, specifically developed for PwPMS. The tool includes multimedia education about being active with PMS, tailored physical activity ideas and interactive functions enabling the development of personalised activity programmes, goal setting and activity logs. The digital tool works in conjunction with support from trained physiotherapists. The feasibility study will evaluate how the LEAP-MS intervention can be used in practice.




Primary Outcome Measures :
  1. Recruitment rate [ Time Frame: 6 months ]

    assessed as the percentage of those submitting online permission to contact forms who are eligible and who consent to participation.

    The primary outcome will be based on the feasibility of the study in terms of quantitative measures of recruitment, retention and intervention uptake. These proportions will be tabulated with 95% confidence intervals alongside the CONSORT chart. No formal hypothesis tests will be carried out in the analysis. Intervention uptake data will be summarised based on the proportion of participants engaging with the intervention. Factors such as disease severity (as represented by EDSS scores) and self-efficacy that may plausibly impact on intervention uptake and retention will be explored. Safety data will be collected through self-reporting by the participant on the digital interactive education and activity tool. Acceptability of the intervention to both PwPMS and physiotherapists (usability, content, design, and language) and fidelity will be assessed.


  2. Retention rate [ Time Frame: 6 months ]
    will be measured as the percentage of individuals who complete the 3 and 6 month follow-up assessments

  3. Intervention uptake [ Time Frame: 6 months ]
    will be defined as percentage of intervention sessions completed which may be reflected as number of completed physiotherapy led coaching sessions and number of remote physiotherapist contacts, website log in rates, length of time between each log in episode and duration of logged activity.

  4. Costs associated with intervention delivery [ Time Frame: 6 months ]
    potential therapist travel and contact time will be recorded

  5. Incidence of Treatment-Emergent Adverse Events [ Time Frame: 6 months ]
    will be assessed by an online process of self-reporting by the participant

  6. Acceptability assessment (process evaluation) [ Time Frame: 6 months ]
    will focus on content, design, language and adaptability to personal needs and will be assessed through use of any remote contact facility and semi-structured interviews (either face to face or by telephone) with participants who completed the intervention and physiotherapists who delivered the intervention

  7. Fidelity of intervention delivery [ Time Frame: 6 months ]
    will be assessed through sampled observations of interactive physiotherapy consultations.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03951181


Locations
Layout table for location information
United Kingdom
Centre for Trials Research
Cardiff, United Kingdom, CF144YS
Sponsors and Collaborators
Cardiff University
Investigators
Layout table for investigator information
Principal Investigator: Monica Busse Cardiff Unviersity
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Cardiff University
ClinicalTrials.gov Identifier: NCT03951181    
Other Study ID Numbers: SPON1666-18
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: March 4, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases