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

CompletedNot a drug-phase studyMS (type not specified)NCT05234879

We could not find results for this trial

What it found

No results found

We found no results in the registry or in papers.

This trial finished 2 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Frame Running

What it measured

Main measures

  • Exercise Self Efficacy Scale

    baseline

    Physical function
  • Exercise Self Efficacy Scale

    12 weeks

    Physical function
  • Psychological Impact of Assistive Devices Scale

    baseline

  • Psychological Impact of Assistive Devices Scale

    12 weeks

  • Five times sit-to-stand test

    baseline

    Physical function
  • Five times sit-to-stand test

    12 weeks

    Physical function
  • Canadian Occupational Performance Measure

    baseline

  • Canadian Occupational Performance Measure

    12 weeks

  • Resting blood pressure

    baseline

  • Resting blood pressure

    12 weeks

  • six minute Frame Running test

    baseline

    Walking and mobility
  • six minute Frame Running test

    11 weeks

    Walking and mobility
  • Frame Running shuttle run/walk test

    baseline

    Walking and mobility
  • Frame Running shuttle run/walk test

    12 weeks

    Walking and mobility
  • weekly step count

    baseline

  • weekly step count

    11 weeks

  • Fatigue Scale for Motor and Cognitive Functions (FSMC)

    baseline

    Thinking and memoryFatigue
  • Fatigue Scale for Motor and Cognitive Functions (FSMC)

    12 weeks

    Thinking and memoryFatigue
  • Multiple Sclerosis Walking Scale

    baseline

    Walking and mobility
  • Multiple Sclerosis Walking Scale

    12 weeks

    Walking and mobility
  • Godin Leisure time exercise questionnaire

    baseline

    Physical function
  • Godin Leisure time exercise questionnaire

    12 weeks

    Physical function

Other measures (3)

  • number of weekly training session attended

    12 weeks

  • Heart rate during the training session

    3 weeks

  • Heart rate during the training session

    8 weeks

Who could take part

MS (type not specified) · 18 and over · EDSS 3.5 to 7

Show the full 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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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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History

    1. Started

      May 2022

    2. Main results due

      Sept 2024

    3. Finished

      Sept 2024

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