Clinical trial NCT05234879: The Feasibility of Frame Running as an Exercise Option for People With Multiple Sclerosis
Official title: The Feasibility of Frame Running as an Exercise Option for People With Multiple Sclerosis With Impaired Balance and Mobility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Queen Margaret University
Sponsor class: OTHER
Collaborators: name: Multiple Sclerosis Society of Great Britain
First posted: 2022-02-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Exercise Self Efficacy Scale
timeFrame: baseline
measure: Exercise Self Efficacy Scale
timeFrame: 12 weeks
measure: Psychological Impact of Assistive Devices Scale
timeFrame: baseline
measure: Psychological Impact of Assistive Devices Scale
timeFrame: 12 weeks
measure: Five times sit-to-stand test
timeFrame: baseline
measure: Five times sit-to-stand test
timeFrame: 12 weeks
measure: Canadian Occupational Performance Measure
timeFrame: baseline
measure: Canadian Occupational Performance Measure
timeFrame: 12 weeks
measure: Resting blood pressure
timeFrame: baseline
measure: Resting blood pressure
timeFrame: 12 weeks
measure: six minute Frame Running test
timeFrame: baseline
measure: six minute Frame Running test
timeFrame: 11 weeks
measure: Frame Running shuttle run/walk test
timeFrame: baseline
measure: Frame Running shuttle run/walk test
timeFrame: 12 weeks
measure: weekly step count
timeFrame: baseline
measure: weekly step count
timeFrame: 11 weeks
measure: Fatigue Scale for Motor and Cognitive Functions (FSMC)
timeFrame: baseline
measure: Fatigue Scale for Motor and Cognitive Functions (FSMC)
timeFrame: 12 weeks
measure: Multiple Sclerosis Walking Scale
timeFrame: baseline
measure: Multiple Sclerosis Walking Scale
timeFrame: 12 weeks
measure: Godin Leisure time exercise questionnaire
timeFrame: baseline
measure: Godin Leisure time exercise questionnaire
timeFrame: 12 weeks
Secondary outcomes:
measure: number of weekly training session attended
timeFrame: 12 weeks
measure: Heart rate during the training session
timeFrame: 3 weeks
measure: Heart rate during the training session
timeFrame: 8 weeks
Other outcomes:
measure: focus groups
timeFrame: 12 weeks
Locations:
city: Musselburgh
country: United Kingdom
facility: Queen Margaret University
state: East Lothian
Study officials:
affiliation: Queen Margaret University
name: Marietta L van der Linden, PhD
role: PRINCIPAL_INVESTIGATOR
References: