Multiple Sclerosis
Conditions
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.
Interventions
OTHERFrame 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.
Sponsors
Multiple Sclerosis Society of Great Britain
Queen Margaret University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Godin Leisure time exercise questionnaire | baseline | questionnaire (range 0-119) higher scores indicate higher level of leisure time exercise participation |
| weekly step count | baseline | Measured using an ActivPAL activity monitor |
| Fatigue Scale for Motor and Cognitive Functions (FSMC) | baseline | questionnaire (range 20 to 100) higher scores indicate higher self-reported fatigue |
| Multiple Sclerosis Walking Scale | baseline | questionnaire (range 12-60) higher scores indicate higher self-reported limitation in walking ability |
| Exercise Self Efficacy Scale | baseline | questionnaire (range 10-40) higher scores indicate higher self-efficacy |
| Psychological Impact of Assistive Devices Scale | baseline | questionnaire (range -3 to 3) higher score indicate improvement in psychosocial impact |
| Five times sit-to-stand test | baseline | measurer of functional strength, Duration, measured in seconds |
| Canadian Occupational Performance Measure | baseline | semi-structured interview (ratings range from 1 to 10, higher scores indicate higher perceived improvement in function |
| Resting blood pressure | baseline | resting blood pressure in mmHg |
| six minute Frame Running test | baseline | measured in meters travelled during 6 minutes, test conducted on a running track |
| Frame Running shuttle run/walk test | baseline | test conducting on the running track, outcome is number of shuttles performed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number of weekly training session attended | 12 weeks | range 0 to 12 |
| Heart rate during the training session | 3 weeks | maximum HR and time spent in HR zones |
Other
| Measure | Time frame | Description |
|---|---|---|
| focus groups | 12 weeks | insights into participant's views on positive and negative experiences or impacts and thoughts on ongoing participation |
Countries
United Kingdom
Outcome results
None listed