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

Study Overview
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Brief Summary
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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.

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

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Other: Frame Running


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Frame Running intervention<br>Participants will be invited to 12 Frame Running training sessions | Other: Frame Running<br>* 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.<br>|

What is the study measuring?
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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 |