The Feasibility of Frame Running as an Exercise Option for People With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

The Feasibility of Frame Running as an Exercise Option for People With Multiple Sclerosis With Impaired Balance and Mobility

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05234879
• Other study ID #: PM1951QMU
• Status: Recruiting
• Phase: N/A
• Start date: May 4, 2022
• Est. completion date: March 31, 2024

Study information

• Verified date: November 2023
• Source: Queen Margaret University
• Contact: Marietta L van der Linden, PhD
• Phone: +44 131 470000
• Email: mvanderlinden[@]qmu.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 31, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Queen Margaret University	Musselburgh	East Lothian

Sponsors (2)

Lead Sponsor	Collaborator
Queen Margaret University	Multiple Sclerosis Society of Great Britain

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	focus groups	insights into participant's views on positive and negative experiences or impacts and thoughts on ongoing participation	12 weeks
Primary	Exercise Self Efficacy Scale	questionnaire (range 10-40) higher scores indicate higher self-efficacy	baseline
Primary	Exercise Self Efficacy Scale	questionnaire (range 10-40) higher scores indicate higher self-efficacy	12 weeks
Primary	Psychological Impact of Assistive Devices Scale	questionnaire (range -3 to 3) higher score indicate improvement in psychosocial impact	baseline
Primary	Psychological Impact of Assistive Devices Scale	questionnaire (range -3 to 3) higher score indicate improvement in psychosocial impact	12 weeks
Primary	Five times sit-to-stand test	measurer of functional strength, Duration, measured in seconds	baseline
Primary	Five times sit-to-stand test	measurer of functional strength, Duration, measured in seconds	12 weeks
Primary	Canadian Occupational Performance Measure	semi-structured interview (ratings range from 1 to 10, higher scores indicate higher perceived improvement in function	baseline
Primary	Canadian Occupational Performance Measure	semi-structured interview (ratings range from 1 to 10, higher scores indicate higher perceived improvement in function	12 weeks
Primary	Resting blood pressure	resting blood pressure in mmHg	baseline
Primary	Resting blood pressure	resting blood pressure in mmHg	12 weeks
Primary	six minute Frame Running test	measured in meters travelled during 6 minutes, test conducted on a running track	baseline
Primary	six minute Frame Running test	measured in meters travelled during 6 minutes, test conducted on a running track	11 weeks
Primary	Frame Running shuttle run/walk test	test conducting on the running track, outcome is number of shuttles performed	baseline
Primary	Frame Running shuttle run/walk test	test conducting on the running track, outcome is number of shuttles performed	12 weeks
Primary	weekly step count	Measured using an ActivPAL activity monitor	baseline
Primary	weekly step count	Measured using an ActivPAL activity monitor	11 weeks
Primary	Fatigue Scale for Motor and Cognitive Functions (FSMC)	questionnaire (range 20 to 100) higher scores indicate higher self-reported fatigue	baseline
Primary	Fatigue Scale for Motor and Cognitive Functions (FSMC)	questionnaire (range 20 to 100) higher scores indicate higher self-reported fatigue	12 weeks
Primary	Multiple Sclerosis Walking Scale	questionnaire (range 12-60) higher scores indicate higher self-reported limitation in walking ability	baseline
Primary	Multiple Sclerosis Walking Scale	questionnaire (range 12-60) higher scores indicate higher self-reported limitation in walking ability	12 weeks
Primary	Godin Leisure time exercise questionnaire	questionnaire (range 0-119) higher scores indicate higher level of leisure time exercise participation	baseline
Primary	Godin Leisure time exercise questionnaire	questionnaire (range 0-119) higher scores indicate higher level of leisure time exercise participation	12 weeks
Secondary	number of weekly training session attended	range 0 to 12	12 weeks
Secondary	Heart rate during the training session	maximum HR and time spent in HR zones	3 weeks
Secondary	Heart rate during the training session	maximum HR and time spent in HR zones	8 weeks