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Clinical Trials/NCT05234879
NCT05234879
Completed
Not Applicable

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

Queen Margaret University1 site in 1 country10 target enrollmentMay 4, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
Queen Margaret University
Enrollment
10
Locations
1
Primary Endpoint
Frame Running shuttle run/walk test
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 4, 2022
End Date
September 29, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Marietta van der Linden

Senior research fellow

Queen Margaret University

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
  • 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.

Outcomes

Primary Outcomes

Frame Running shuttle run/walk test

Time Frame: 12 weeks

test conducting on the running track, outcome is number of shuttles performed

Fatigue Scale for Motor and Cognitive Functions (FSMC)

Time Frame: 12 weeks

questionnaire (range 20 to 100) higher scores indicate higher self-reported fatigue

Resting blood pressure

Time Frame: 12 weeks

resting blood pressure in mmHg

weekly step count

Time Frame: 11 weeks

Measured using an ActivPAL activity monitor

Five times sit-to-stand test

Time Frame: 12 weeks

measurer of functional strength, Duration, measured in seconds

Psychological Impact of Assistive Devices Scale

Time Frame: 12 weeks

questionnaire (range -3 to 3) higher score indicate improvement in psychosocial impact

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

Godin Leisure time exercise questionnaire

Time Frame: 12 weeks

questionnaire (range 0-119) higher scores indicate higher level of leisure time exercise participation

Exercise Self Efficacy Scale

Time Frame: 12 weeks

questionnaire (range 10-40) higher scores indicate higher self-efficacy

six minute Frame Running test

Time Frame: 11 weeks

measured in meters travelled during 6 minutes, test conducted on a running track

Multiple Sclerosis Walking Scale

Time Frame: 12 weeks

questionnaire (range 12-60) higher scores indicate higher self-reported limitation in walking ability

Secondary Outcomes

  • number of weekly training session attended(12 weeks)
  • Heart rate during the training session(8 weeks)

Study Sites (1)

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