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

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Other: Frame Running

• Registration Number: NCT05234879
• Lead Sponsor: Queen Margaret University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-20
• Study First Submitted QC: 2022-02-01
• Study First Posted: 2022-02-10
• Study Start: 2022-05-04
• Primary Completion: 2024-09-29
• Study Completion: 2024-09-29
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Frame Running intervention	Frame Running	Participants will be invited to 12 Frame Running training sessions

Primary Outcome Measures

Name	Time	Method
weekly step count	11 weeks	Measured using an ActivPAL activity monitor
Frame Running shuttle run/walk test	12 weeks	test conducting on the running track, outcome is number of shuttles performed
Fatigue Scale for Motor and Cognitive Functions (FSMC)	12 weeks	questionnaire (range 20 to 100) higher scores indicate higher self-reported fatigue
Resting blood pressure	12 weeks	resting blood pressure in mmHg
Five times sit-to-stand test	12 weeks	measurer of functional strength, Duration, measured in seconds
Psychological Impact of Assistive Devices Scale	12 weeks	questionnaire (range -3 to 3) higher score indicate improvement in psychosocial impact
Canadian Occupational Performance Measure	12 weeks	semi-structured interview (ratings range from 1 to 10, higher scores indicate higher perceived improvement in function
Godin Leisure time exercise questionnaire	12 weeks	questionnaire (range 0-119) higher scores indicate higher level of leisure time exercise participation
Exercise Self Efficacy Scale	12 weeks	questionnaire (range 10-40) higher scores indicate higher self-efficacy
six minute Frame Running test	11 weeks	measured in meters travelled during 6 minutes, test conducted on a running track
Multiple Sclerosis Walking Scale	12 weeks	questionnaire (range 12-60) higher scores indicate higher self-reported limitation in walking ability

Secondary Outcome Measures

Name	Time	Method
number of weekly training session attended	12 weeks	range 0 to 12
Heart rate during the training session	8 weeks	maximum HR and time spent in HR zones

Trial Locations

Locations (1)

Queen Margaret University; 🇬🇧 Musselburgh, East Lothian, United Kingdom