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Completed

NCT Number: NCT05234879

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Margaret University

Musselburgh, East Lothian, EH21 6UU, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Frame Running

Other

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.

Primary outcomes

  1. Exercise Self Efficacy Scale

    Time frame: baseline

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

  2. Exercise Self Efficacy Scale

    Time frame: 12 weeks

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

  3. Psychological Impact of Assistive Devices Scale

    Time frame: baseline

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

  4. Psychological Impact of Assistive Devices Scale

    Time frame: 12 weeks

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

  5. Five times sit-to-stand test

    Time frame: baseline

    measurer of functional strength, Duration, measured in seconds

  6. Five times sit-to-stand test

    Time frame: 12 weeks

    measurer of functional strength, Duration, measured in seconds

  7. Canadian Occupational Performance Measure

    Time frame: baseline

    semi-structured interview (ratings range from 1 to 10, higher scores indicate higher perceived improvement in function

  8. 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

  9. Resting blood pressure

    Time frame: baseline

    resting blood pressure in mmHg

  10. Resting blood pressure

    Time frame: 12 weeks

    resting blood pressure in mmHg

  11. six minute Frame Running test

    Time frame: baseline

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

  12. six minute Frame Running test

    Time frame: 11 weeks

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

  13. Frame Running shuttle run/walk test

    Time frame: baseline

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

  14. Frame Running shuttle run/walk test

    Time frame: 12 weeks

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

  15. weekly step count

    Time frame: baseline

    Measured using an ActivPAL activity monitor

  16. weekly step count

    Time frame: 11 weeks

    Measured using an ActivPAL activity monitor

  17. Fatigue Scale for Motor and Cognitive Functions (FSMC)

    Time frame: baseline

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

  18. Fatigue Scale for Motor and Cognitive Functions (FSMC)

    Time frame: 12 weeks

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

  19. Multiple Sclerosis Walking Scale

    Time frame: baseline

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

  20. Multiple Sclerosis Walking Scale

    Time frame: 12 weeks

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

  21. Godin Leisure time exercise questionnaire

    Time frame: baseline

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

  22. Godin Leisure time exercise questionnaire

    Time frame: 12 weeks

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

Secondary outcomes

  1. number of weekly training session attended

    Time frame: 12 weeks

    range 0 to 12

  2. Heart rate during the training session

    Time frame: 3 weeks

    maximum HR and time spent in HR zones

  3. Heart rate during the training session

    Time frame: 8 weeks

    maximum HR and time spent in HR zones

Other outcomes

  1. focus groups

    Time frame: 12 weeks

    insights into participant's views on positive and negative experiences or impacts and thoughts on ongoing participation

Sponsors and collaborators

Lead sponsor

Queen Margaret University

Other

Collaborators

  • Multiple Sclerosis Society of Great Britain

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 10, 2022
Registry last updated
Oct 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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