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

The Feasibility of Frame Running as an Exercise Option for People With Multiple Sclerosis With Impaired Balance and Mobility

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Frame Running

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • East Lothian
    • Musselburgh, East Lothian, United Kingdom, EH21 6UU
      • Queen Margaret University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Those with contraindications to exercise, those unable to safely propel the frame for any distance on their own using the try-out sessions and those with more than 10 hours of FR experience will be excluded from participation in this study. Other exclusion criteria are lower limb surgery less than 3 months prior to the start of the study, having started disease modifying and/or spasticity treatment less than 3 months prior to the start of the study and severe visual impairment affecting the ability to safely take part in Frame Running training sessions.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Frame Running intervention; Participants will be invited to 12 Frame Running training sessions	Other: Frame Running; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of weekly training session attended	range 0 to 12	12 weeks
Heart rate during the training session	maximum HR and time spent in HR zones	3 weeks
Heart rate during the training session	maximum HR and time spent in HR zones	8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
focus groups	insights into participant's views on positive and negative experiences or impacts and thoughts on ongoing participation	12 weeks

Collaborators and Investigators

• Sponsor: Queen Margaret University
• Collaborators: Multiple Sclerosis Society of Great Britain
• Investigators: Principal Investigator: Marietta L van der Linden, PhD, Queen Margaret University

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2022
• Primary Completion (Actual): September 29, 2024
• Study Completion (Actual): September 29, 2024

Study Registration Dates

• First Submitted: January 20, 2022
• First Submitted That Met QC Criteria: February 1, 2022
• First Posted (Actual): February 10, 2022

Study Record Updates

• Last Update Posted (Actual): October 18, 2024
• Last Update Submitted That Met QC Criteria: October 16, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: PM1951QMU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: overall study outcomes will be shared
• IPD Sharing Time Frame: The data will be available as part of a publication which expected to be 31/12/2023 the latest
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No