An interventional study of Frame Running in Multiple Sclerosis, sponsored by Queen Margaret University. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-18.
Sponsored by Queen Margaret University · Not applicable, Interventional, and Other
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.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 10 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Queen Margaret University is the lead sponsor of 34 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Exercise Self Efficacy Scale
questionnaire (range 10-40) higher scores indicate higher self-efficacy
Time frame: baseline
Exercise Self Efficacy Scale
questionnaire (range 10-40) higher scores indicate higher self-efficacy
Time frame: 12 weeks
Psychological Impact of Assistive Devices Scale
questionnaire (range -3 to 3) higher score indicate improvement in psychosocial impact
Time frame: baseline
Psychological Impact of Assistive Devices Scale
questionnaire (range -3 to 3) higher score indicate improvement in psychosocial impact
Time frame: 12 weeks
Five times sit-to-stand test
measurer of functional strength, Duration, measured in seconds
Time frame: baseline
Five times sit-to-stand test
measurer of functional strength, Duration, measured in seconds
Time frame: 12 weeks
Canadian Occupational Performance Measure
semi-structured interview (ratings range from 1 to 10, higher scores indicate higher perceived improvement in function
Time frame: baseline
Canadian Occupational Performance Measure
semi-structured interview (ratings range from 1 to 10, higher scores indicate higher perceived improvement in function
Time frame: 12 weeks
Resting blood pressure
resting blood pressure in mmHg
Time frame: baseline
Resting blood pressure
resting blood pressure in mmHg
Time frame: 12 weeks
six minute Frame Running test
measured in meters travelled during 6 minutes, test conducted on a running track
Time frame: baseline
six minute Frame Running test
measured in meters travelled during 6 minutes, test conducted on a running track
Time frame: 11 weeks
Frame Running shuttle run/walk test
test conducting on the running track, outcome is number of shuttles performed
Time frame: baseline
Frame Running shuttle run/walk test
test conducting on the running track, outcome is number of shuttles performed
Time frame: 12 weeks
weekly step count
Measured using an ActivPAL activity monitor
Time frame: baseline
weekly step count
Measured using an ActivPAL activity monitor
Time frame: 11 weeks
Fatigue Scale for Motor and Cognitive Functions (FSMC)
questionnaire (range 20 to 100) higher scores indicate higher self-reported fatigue
Time frame: baseline
Fatigue Scale for Motor and Cognitive Functions (FSMC)
questionnaire (range 20 to 100) higher scores indicate higher self-reported fatigue
Time frame: 12 weeks
Multiple Sclerosis Walking Scale
questionnaire (range 12-60) higher scores indicate higher self-reported limitation in walking ability
Time frame: baseline
Multiple Sclerosis Walking Scale
questionnaire (range 12-60) higher scores indicate higher self-reported limitation in walking ability
Time frame: 12 weeks
Godin Leisure time exercise questionnaire
questionnaire (range 0-119) higher scores indicate higher level of leisure time exercise participation
Time frame: baseline
Godin Leisure time exercise questionnaire
questionnaire (range 0-119) higher scores indicate higher level of leisure time exercise participation
Time frame: 12 weeks
number of weekly training session attended
range 0 to 12
Time frame: 12 weeks
Heart rate during the training session
maximum HR and time spent in HR zones
Time frame: 3 weeks
Heart rate during the training session
maximum HR and time spent in HR zones
Time frame: 8 weeks
focus groups
insights into participant's views on positive and negative experiences or impacts and thoughts on ongoing participation
Time frame: 12 weeks
Plan to share: Yes — overall study outcomes will be shared
Supporting information: Study protocol, Sap, Csr
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Queen Margaret University