The Feasibility of Frame Running as an Exercise Option for People With Multiple Sclerosis With Impaired Balance and Mobility
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Frame Running shuttle run/walk test
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Frame Running intervention
Participants will be invited to 12 Frame Running training sessions
干预措施: Frame Running (Other)
结局指标
主要结局
Frame Running shuttle run/walk test
时间窗: 12 weeks
test conducting on the running track, outcome is number of shuttles performed
Fatigue Scale for Motor and Cognitive Functions (FSMC)
时间窗: 12 weeks
questionnaire (range 20 to 100) higher scores indicate higher self-reported fatigue
Resting blood pressure
时间窗: 12 weeks
resting blood pressure in mmHg
weekly step count
时间窗: 11 weeks
Measured using an ActivPAL activity monitor
Five times sit-to-stand test
时间窗: 12 weeks
measurer of functional strength, Duration, measured in seconds
Psychological Impact of Assistive Devices Scale
时间窗: 12 weeks
questionnaire (range -3 to 3) higher score indicate improvement in psychosocial impact
Canadian Occupational Performance Measure
时间窗: 12 weeks
semi-structured interview (ratings range from 1 to 10, higher scores indicate higher perceived improvement in function
Godin Leisure time exercise questionnaire
时间窗: 12 weeks
questionnaire (range 0-119) higher scores indicate higher level of leisure time exercise participation
Exercise Self Efficacy Scale
时间窗: 12 weeks
questionnaire (range 10-40) higher scores indicate higher self-efficacy
six minute Frame Running test
时间窗: 11 weeks
measured in meters travelled during 6 minutes, test conducted on a running track
Multiple Sclerosis Walking Scale
时间窗: 12 weeks
questionnaire (range 12-60) higher scores indicate higher self-reported limitation in walking ability
Psychological Impact of Assistive Devices Scale
时间窗: baseline
questionnaire (range -3 to 3) higher score indicate improvement in psychosocial impact
Exercise Self Efficacy Scale
时间窗: baseline
questionnaire (range 10-40) higher scores indicate higher self-efficacy
Five times sit-to-stand test
时间窗: baseline
measurer of functional strength, Duration, measured in seconds
Canadian Occupational Performance Measure
时间窗: baseline
semi-structured interview (ratings range from 1 to 10, higher scores indicate higher perceived improvement in function
Resting blood pressure
时间窗: baseline
resting blood pressure in mmHg
six minute Frame Running test
时间窗: baseline
measured in meters travelled during 6 minutes, test conducted on a running track
Frame Running shuttle run/walk test
时间窗: baseline
test conducting on the running track, outcome is number of shuttles performed
weekly step count
时间窗: baseline
Measured using an ActivPAL activity monitor
Fatigue Scale for Motor and Cognitive Functions (FSMC)
时间窗: baseline
questionnaire (range 20 to 100) higher scores indicate higher self-reported fatigue
Multiple Sclerosis Walking Scale
时间窗: baseline
questionnaire (range 12-60) higher scores indicate higher self-reported limitation in walking ability
Godin Leisure time exercise questionnaire
时间窗: baseline
questionnaire (range 0-119) higher scores indicate higher level of leisure time exercise participation
次要结局
- number of weekly training session attended(12 weeks)
- Heart rate during the training session(8 weeks)
- Heart rate during the training session(3 weeks)
研究者
Marietta van der Linden
Senior research fellow
Queen Margaret University