Multiple Sclerosis Fitness Intervention Training With Pilates Exercises
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Change in Timed Up & Go (TUG)
研究概览
简要总结
To date, despite recent advances in MS care including rehabilitation interventions, many PwMS are unable to access these developments due to limited mobility, fatigue and related issues, and costs associated with travel.
Thus, physical activity at home could be a new way to deliver exercises to the patients. Although Pilates did not show any significant advantage over standardized physical therapy in the current literature, it is a good method to promote physical activity, sensorimotor integration and cognitive stimulation. Thus, it could be a treatment option to improve fatigue, balance and walking abilities in PwMS; consequently, Pilates could be suggested by the clinician as a physical activity to be integrated in the daily life.
This possibility could be made more feasible using new tools such as those offered by low cost devices.
The main MS-FIT project purposes are to provide and to test a tool based on serious game concept of Pilates-inspired exercises for daily use at home, by mixing the entertainment aspects typical of the videogames and the possibility to perform physical activity.
The MS-FIT tool does not pursue therapeutic aims as rehabilitation does, but it could have a positive impact on prevention and health in MS.
MS-FIT, by using the Microsoft Kinect Motion Controller Xbox or similar to deliver adapted physical activity, offers the possibility to transform the Pilates exercises into a virtual reality game.
MS-FIT, through a multicentre approach, would provide:
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a feasibility study in order to:
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refine the tool for the final customized version to be used in a RCT MS study
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assess the tool for PwMS in terms of technology acceptability and satisfaction-to-use
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assess the process of recruitment, the adherence to the intervention, the dropout rate and identify potential issues
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assess human resources necessary for the RCT
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estimate the effect of the intervention and its variance necessary to calculate the appropriate sample size for the RCT
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a RCT study in order to evaluate the effect of a physical activity intervention of exercises inspired to Pilates self-managed at home in terms on PwMS
详细描述
Devices and technologies for at-home interventions could provide to PwMS with mild disability useful tools to successfully maintain own physical, cognitive and emotional status by performing at-home physical activity/exercises and avoiding outpatient interventions. Together, new devices and technologies could help in overcoming all barriers (i.e. transportations, working time, etc.) hindering the adherence to and, consequently, efficacy of the outpatient treatments.
Although Pilates did not show any significant advantage over standardized physical therapy in the current literature, it is a good method to promote physical activity, sensorimotor integration and cognitive stimulation. Thus, it could be a treatment option to improve fatigue, balance and walking abilities in PwMS; consequently, Pilates could be suggested by the clinician as a physical activity to be integrated in the daily life.
This possibility could be made more feasible using new tools such as those offered by low cost devices.
The main MS-FIT project purposes are to provide and to test a tool based on serious game concept of Pilates-inspired exercises for daily use at home, by mixing the entertainment aspects typical of the videogames and the possibility to perform physical activity.
The MS-FIT tool does not pursue therapeutic aims as rehabilitation does, but it could have a positive impact on prevention and health in MS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •All disease courses of MS
- •Expanded Disability Status Scale (EDSS) 2-4
- •Hospital Anxiety and Depression Scale (HADS) < 10 in the two subset of anxiety and depression
- •Berg Balance Scale (BBS) > 46
- •Mini-Mental State Examination (MMSE) > 24
- •At least 1 month without having been treated with rehabilitation
- •Willingness to sign informed consent
排除标准
- •Visual deficits that could compromise the use of MS-FIT
- •Relapses in the last 3 months
研究组 & 干预措施
CTRL
No rehabilitative interventions except sphincter and speech rehabilitation and psychological support, are admitted for the 12 weeks of participation to the project and the following 6 weeks before Follow-up evaluations (a total of 18 weeks). The execution of unspecific physical activities, if not already practiced, will be suggested to the participants.
MSFIT
The MSFIT group will self-manage Pilates exercises at-home through a tool based on XBox Kinect for 12 weeks, performing at least 3 sessions/week for a total of 30 minutes of exercises for each session(also distributed during the day with a minimum slot of 10 minutes). No rehabilitative interventions except sphincter and speech rehabilitation and psychological support, are admitted for the 12 weeks of participation to the project and the following 6 weeks before Follow-up evaluations (a total of 18 weeks). The execution of unspecific physical activities, if not already practiced, will be suggested to the participants.
干预措施: MSFIT (Other)
结局指标
主要结局
Change in Timed Up & Go (TUG)
时间窗: T0: before intervention; T1: after 12 weeks of intervention; T2: 6 weeks after T1
The Timed "Up and Go" Test measures, in seconds, the time taken by an individual to stand up from a standard arm chair (approximate seat height of 46 cm, arm height 65 cm), walk a distance of 3 meters (approximately 10 feet), turn, walk back to the chair, and sit down.
次要结局
- Change in 2-Minutes Walking Test (2WT)(T0: before intervention; T1: after 12 weeks of intervention; T2: 6 weeks after T1)
- Change in Technology Acceptance Model (TAM)(T0: before intervention; T1: after 12 weeks of intervention; T2: 6 weeks after T1)
- Change in Client Satisfaction Questionnaire-8 (CSQ-8)(T0: before intervention; T1: after 12 weeks of intervention; T2: 6 weeks after T1)
- Adherence to the intervention based on sessions(T1: after 12 weeks of intervention)
- Change in Visual Analogue Scale (VAS) (0-10) for balance performance(T0: before intervention; T1: after 12 weeks of intervention; T2: 6 weeks after T1)
- Change in Nine-Hole Peg Test (9HPT)(T0: before intervention; T1: after 12 weeks of intervention; T2: 6 weeks after T1)
- Change in Brief International Cognitive Assessment for MS (BICAMS)(T0: before intervention; T1: after 12 weeks of intervention; T2: 6 weeks after T1)
- Change in Psychological Well-Being Scales (PWB)(T0: before intervention; T1: after 12 weeks of intervention; T2: 6 weeks after T1)
- Change in Twelve Item MS Walking Scale (MSWS-12)(T0: before intervention; T1: after 12 weeks of intervention; T2: 6 weeks after T1)
- Change in International Physical Activity Questionnaire (IPAQ)(T0: before intervention; T1: after 12 weeks of intervention; T2: 6 weeks after T1)
- Adherence to the intervention based on drop-out(T1: after 12 weeks of intervention)
- Change in Patient Global Impression of Change (PGIC) with a 7-points scale(T1: after 12 weeks of intervention; T2: 6 weeks after T1)
- Change in Multiple Sclerosis Quality of Life-54 (MSQoL54)(T0: before intervention; T1: after 12 weeks of intervention; T2: 6 weeks after T1)
- Change in Timed 25-Foot Walk (T25FW)(T0: before intervention; T1: after 12 weeks of intervention; T2: 6 weeks after T1)
- Change in Ambulation Index (AI)(T0: before intervention; T1: after 12 weeks of intervention; T2: 6 weeks after T1)
- Change in Telehealth Satisfaction Scale (TeSS)(T0: before intervention; T1: after 12 weeks of intervention; T2: 6 weeks after T1)
- Change in Modified Fatigue Impact Scale (MFIS)(T0: before intervention; T1: after 12 weeks of intervention; T2: 6 weeks after T1)
- Change in Minnesota Leisure-Time Physical Activity Questionnaire(T0: before intervention; T1: after 12 weeks of intervention; T2: 6 weeks after T1)
- Correlation between genetic polymorphisms and response to protocol(T0: before intervention)