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| Name | Class |
|---|---|
| Multiple Sclerosis Society of Great Britain | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Frame Running intervention | Experimental | Participants will be invited to 12 Frame Running training sessions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marietta L van der Linden, PhD | Queen Margaret University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Margaret University | Musselburgh | East Lothian | EH21 6UU | United Kingdom |
overall study outcomes will be shared
The data will be available as part of a publication which expected to be 31/12/2023 the latest
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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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 |
| 3 weeks |
| Heart rate during the training session | maximum HR and time spent in HR zones | 8 weeks |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |