Multiple SclerosisNCT05234879
The Feasibility of Frame Running as an Exercise Option for People With Multiple Sclerosis
A study testing Frame Running in people with Multiple Sclerosis, run by Queen Margaret University at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Frame Running
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 May 2022to 29 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen Margaret University
Musselburgh, East Lothian, EH21 6UU
About this study
Official title: 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Frame Running
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frame RunningOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Frame Running intervention | Experimental | Participants will be invited to 12 Frame Running training sessions Receives: Other: Frame Running |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Self Efficacy Scale
questionnaire (range 10-40) higher scores indicate higher self-efficacy
Measured: baseline
Exercise Self Efficacy Scale
questionnaire (range 10-40) higher scores indicate higher self-efficacy
Measured: 12 weeks
Psychological Impact of Assistive Devices Scale
questionnaire (range -3 to 3) higher score indicate improvement in psychosocial impact
Measured: baseline
Psychological Impact of Assistive Devices Scale
questionnaire (range -3 to 3) higher score indicate improvement in psychosocial impact
Measured: 12 weeks
Five times sit-to-stand test
measurer of functional strength, Duration, measured in seconds
Measured: baseline
Five times sit-to-stand test
measurer of functional strength, Duration, measured in seconds
Measured: 12 weeks
Canadian Occupational Performance Measure
semi-structured interview (ratings range from 1 to 10, higher scores indicate higher perceived improvement in function
Measured: baseline
Canadian Occupational Performance Measure
semi-structured interview (ratings range from 1 to 10, higher scores indicate higher perceived improvement in function
Measured: 12 weeks
Resting blood pressure
resting blood pressure in mmHg
Measured: baseline
Resting blood pressure
resting blood pressure in mmHg
Measured: 12 weeks
six minute Frame Running test
measured in meters travelled during 6 minutes, test conducted on a running track
Measured: baseline
six minute Frame Running test
measured in meters travelled during 6 minutes, test conducted on a running track
Measured: 11 weeks
Frame Running shuttle run/walk test
test conducting on the running track, outcome is number of shuttles performed
Measured: baseline
Frame Running shuttle run/walk test
test conducting on the running track, outcome is number of shuttles performed
Measured: 12 weeks
weekly step count
Measured using an ActivPAL activity monitor
Measured: baseline
weekly step count
Measured using an ActivPAL activity monitor
Measured: 11 weeks
Fatigue Scale for Motor and Cognitive Functions (FSMC)
questionnaire (range 20 to 100) higher scores indicate higher self-reported fatigue
Measured: baseline
Fatigue Scale for Motor and Cognitive Functions (FSMC)
questionnaire (range 20 to 100) higher scores indicate higher self-reported fatigue
Measured: 12 weeks
Multiple Sclerosis Walking Scale
questionnaire (range 12-60) higher scores indicate higher self-reported limitation in walking ability
Measured: baseline
Multiple Sclerosis Walking Scale
questionnaire (range 12-60) higher scores indicate higher self-reported limitation in walking ability
Measured: 12 weeks
Godin Leisure time exercise questionnaire
questionnaire (range 0-119) higher scores indicate higher level of leisure time exercise participation
Measured: baseline
Godin Leisure time exercise questionnaire
questionnaire (range 0-119) higher scores indicate higher level of leisure time exercise participation
Measured: 12 weeks
Secondary outcomes (3)
number of weekly training session attended
range 0 to 12
Measured: 12 weeks
Heart rate during the training session
maximum HR and time spent in HR zones
Measured: 3 weeks
Heart rate during the training session
maximum HR and time spent in HR zones
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start4 May 2022
- Primary completion29 Sep 2024
- Study completion29 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Margaret University
- Sponsor type
- University, hospital or other
- Collaborators
- Multiple Sclerosis Society of Great Britain
- Responsible party
- Principal investigator, Marietta van der Linden, Queen Margaret University
- Investigators
- Marietta L van der Linden, PhD, Principal investigator, Queen Margaret University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05234879
- Sponsor's protocol ID
- PM1951QMU
- Status last verified
- Oct 2024
- First submitted
- 20 Jan 2022
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: overall study outcomes will be shared
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of Frame Running as an Exercise Option for People With Multiple Sclerosis With Impaired Balance and Mobility
- ClinicalTrials.gov ID
- NCT05234879
- Acronym / sponsor ID
- PM1951QMU
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Queen Margaret UniversityUniversity, hospital or other
- Collaborators
- Multiple Sclerosis Society of Great Britain
- Study start
- 4 May 2022 (actual)
- Primary completion
- 29 Sep 2024 (actual)
- Study completion
- 29 Sep 2024 (actual)
- First posted
- 10 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Frame Running intervention | Experimental | Other: Frame RunningParticipants will be invited to 12 Frame Running training sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Frame RunningFrame 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. | Other | Frame Running intervention |
Primary outcome
Exercise Self Efficacy Scale
Time frame: baseline
questionnaire (range 10-40) higher scores indicate higher self-efficacy
Exercise Self Efficacy Scale
Time frame: 12 weeks
questionnaire (range 10-40) higher scores indicate higher self-efficacy
Psychological Impact of Assistive Devices Scale
Time frame: baseline
questionnaire (range -3 to 3) higher score indicate improvement in psychosocial impact
Psychological Impact of Assistive Devices Scale
Time frame: 12 weeks
questionnaire (range -3 to 3) higher score indicate improvement in psychosocial impact
Five times sit-to-stand test
Time frame: baseline
measurer of functional strength, Duration, measured in seconds
Five times sit-to-stand test
Time frame: 12 weeks
measurer of functional strength, Duration, measured in seconds
Canadian Occupational Performance Measure
Time frame: baseline
semi-structured interview (ratings range from 1 to 10, higher scores indicate higher perceived improvement in function
Canadian Occupational Performance Measure
Time frame: 12 weeks
semi-structured interview (ratings range from 1 to 10, higher scores indicate higher perceived improvement in function
Resting blood pressure
Time frame: baseline
resting blood pressure in mmHg
Resting blood pressure
Time frame: 12 weeks
resting blood pressure in mmHg
six minute Frame Running test
Time frame: baseline
measured in meters travelled during 6 minutes, test conducted on a running track
six minute Frame Running test
Time frame: 11 weeks
measured in meters travelled during 6 minutes, test conducted on a running track
Frame Running shuttle run/walk test
Time frame: baseline
test conducting on the running track, outcome is number of shuttles performed
Frame Running shuttle run/walk test
Time frame: 12 weeks
test conducting on the running track, outcome is number of shuttles performed
weekly step count
Time frame: baseline
Measured using an ActivPAL activity monitor
weekly step count
Time frame: 11 weeks
Measured using an ActivPAL activity monitor
Fatigue Scale for Motor and Cognitive Functions (FSMC)
Time frame: baseline
questionnaire (range 20 to 100) higher scores indicate higher self-reported fatigue
Fatigue Scale for Motor and Cognitive Functions (FSMC)
Time frame: 12 weeks
questionnaire (range 20 to 100) higher scores indicate higher self-reported fatigue
Multiple Sclerosis Walking Scale
Time frame: baseline
questionnaire (range 12-60) higher scores indicate higher self-reported limitation in walking ability
Multiple Sclerosis Walking Scale
Time frame: 12 weeks
questionnaire (range 12-60) higher scores indicate higher self-reported limitation in walking ability
Godin Leisure time exercise questionnaire
Time frame: baseline
questionnaire (range 0-119) higher scores indicate higher level of leisure time exercise participation
Godin Leisure time exercise questionnaire
Time frame: 12 weeks
questionnaire (range 0-119) higher scores indicate higher level of leisure time exercise participation
3 secondary outcomes
number of weekly training session attended
Time frame: 12 weeks
Heart rate during the training session
Time frame: 3 weeks
Heart rate during the training session
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Individual participant dataSharing planned: Yes. overall study outcomes will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marietta L van der Linden, PhD principal investigator
Queen Margaret University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Frame Running in people with Multiple Sclerosis, run by Queen Margaret University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise Self Efficacy Scale (time frame: baseline). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.