The Feasibility of Frame Running as an Exercise Option for People With Multiple Sclerosis

NCT05234879 | Completed

• 1 other identifier: PM1951QMU
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

There is ample evidence that regular exercise can reduce MS specific symptoms and improve health and wellbeing in people with MS. However, for people with MS to engage in exercise activities long term, it is important that they are offered a range of exercise opportunities that are safe, feasible and potentially effective to reduce MS symptom. This will allow people to select an activity they enjoy, is adapted to their needs and thus are more sustainable long-term. Frame Running (FR) provides an opportunity for people with walking and balance problems to walk or run safely without the risk of falling. The frame consists of three wheels and has a saddle and handlebars like a trike without pedals. The proposed mixed methods study aims to examine the feasibility and acceptability of FR as a sustainable aerobic exercise option for people with MS and the feasibility of conducting a future definite trial into the impact of FR on functional mobility, fatigue, cardiorespiratory function and psychosocial outcomes. People who experience problems with their walking and/or balance will be eligible to take part in this study which consists of a 12 weekly group FR training sessions led by a qualified coach. FR training attendance, recruitment, retention, outcome measure completion and adverse events will be recorded and the participant views on the feasibility, acceptability and impact of FR will be explored through the use of focus groups. Physical function, physical activity and psychosocial outcomes will be assessed at baseline, 6 and 12 weeks.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (22)

• Exercise Self Efficacy Scale

  questionnaire (range 10-40) higher scores indicate higher self-efficacy

  baseline

• Exercise Self Efficacy Scale

  questionnaire (range 10-40) higher scores indicate higher self-efficacy

  12 weeks

• Psychological Impact of Assistive Devices Scale

  questionnaire (range -3 to 3) higher score indicate improvement in psychosocial impact

  baseline

• Psychological Impact of Assistive Devices Scale

  questionnaire (range -3 to 3) higher score indicate improvement in psychosocial impact

  12 weeks

• Five times sit-to-stand test

  measurer of functional strength, Duration, measured in seconds

  baseline

• Five times sit-to-stand test

  measurer of functional strength, Duration, measured in seconds

  12 weeks

• Canadian Occupational Performance Measure

  semi-structured interview (ratings range from 1 to 10, higher scores indicate higher perceived improvement in function

  baseline

• Canadian Occupational Performance Measure

  semi-structured interview (ratings range from 1 to 10, higher scores indicate higher perceived improvement in function

  12 weeks

• Resting blood pressure

  resting blood pressure in mmHg

  baseline

• Resting blood pressure

  resting blood pressure in mmHg

  12 weeks

• six minute Frame Running test

  measured in meters travelled during 6 minutes, test conducted on a running track

  baseline

• six minute Frame Running test

  measured in meters travelled during 6 minutes, test conducted on a running track

  11 weeks

• Frame Running shuttle run/walk test

  test conducting on the running track, outcome is number of shuttles performed

  baseline

• Frame Running shuttle run/walk test

  test conducting on the running track, outcome is number of shuttles performed

  12 weeks

• weekly step count

  Measured using an ActivPAL activity monitor

  baseline

• weekly step count

  Measured using an ActivPAL activity monitor

  11 weeks

• Fatigue Scale for Motor and Cognitive Functions (FSMC)

  questionnaire (range 20 to 100) higher scores indicate higher self-reported fatigue

  baseline

• Fatigue Scale for Motor and Cognitive Functions (FSMC)

  questionnaire (range 20 to 100) higher scores indicate higher self-reported fatigue

  12 weeks

• Multiple Sclerosis Walking Scale

  questionnaire (range 12-60) higher scores indicate higher self-reported limitation in walking ability

  baseline

• Multiple Sclerosis Walking Scale

  questionnaire (range 12-60) higher scores indicate higher self-reported limitation in walking ability

  12 weeks

• Godin Leisure time exercise questionnaire

  questionnaire (range 0-119) higher scores indicate higher level of leisure time exercise participation

  baseline

• Godin Leisure time exercise questionnaire

  questionnaire (range 0-119) higher scores indicate higher level of leisure time exercise participation

  12 weeks

Secondary Outcomes (3)

• number of weekly training session attended

  12 weeks

• Heart rate during the training session

  3 weeks

• Heart rate during the training session

  8 weeks

Other Outcomes (1)

• focus groups

  12 weeks

Study Arms (1)

Frame Running intervention

EXPERIMENTAL

Participants will be invited to 12 Frame Running training sessions

Other: Frame Running

Interventions

Frame Running OTHER

Frame Running (FR) provides an opportunity for people with walking and balance problems to walk or run safely without the risk of falling. The frame consists of three wheels and has a saddle and handlebars like a trike without pedals.

Frame Running intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• People with a definite diagnosis of MS according to the revised MacDonald criteria, aged 18 and over, experiencing walking or balance difficulties but able to transfer independently will be eligible to take part in this study. This equates to people with an EDSS of 3.5 to 7. In order to be eligible for taking part in the Frame Running sessions, people should also be able comprehend and follow instructions relating to participation training as well as have sufficient understanding of the English language to complete the consent forms and questionnaires

Sponsors & Collaborators

• Queen Margaret University: lead
• Multiple Sclerosis Society of Great Britain: collaborator

Study Sites (1)

Queen Margaret University

Musselburgh, East Lothian, EH21 6UU, United Kingdom

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Marietta L van der Linden, PhD

  Queen Margaret University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior research fellow

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: February 10, 2022
• Study Start: May 4, 2022
• Primary Completion: September 29, 2024
• Study Completion: September 29, 2024
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: The data will be available as part of a publication which expected to be 31/12/2023 the latest

Locations

GB (1)