Sport, Rehabilitation and Nutrition in Multiple Sclerosis: The LINUS Project
2021年5月5日 更新者：Fondazione Don Carlo Gnocchi Onlus
Sport, Rehabilitation and Nutrition in Multiple Sclerosis: An Innovative Multidisciplinary High Impact Intervention for the Lifestyle Change
Only a limited percentage of persons with MS (pwMS) participate to multidisciplinary rehabilitation because of poor support, knowledge and motivation. The investigators reasoned that pwMS should be more effectively prepared to increase their adherence. This study propose the implementation of an innovative collaborative approach, called "brief high-impact preparatory experience" (b-HIPE), inspired by an overarching model based on the interplay between competence, motivation and opportunity to increase in a short time awareness and motivation of pwMS.
The aim of the study is the evaluation of its feasibility. For this pilot study the investigator chose a single-group design with repeated measurements at baseline and post intervention.
研究概览
研究类型
介入性
注册 (预期的)
30
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Laura LM Mendozzi, MD
- 电话号码：+39 02 40308571
- 邮箱：lmendozzi@dongnocchi.it
学习地点
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Milan、意大利
- 招聘中
- IRCCS Fondazione Don Carlo Gnocchi
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- aged 18 to 70 years
- EDSS ranging from 1 to 7.5.
- pwMS with who are on a western diet
- stabilized medical therapy and clinical conditions
- pwMS with a motor control of upper limbs sufficient to maneuver a tiller
Exclusion Criteria:
- Heavy smoking, alcohol and drugs abuse
- severe cognitive impairment
- dysphagia and/or comorbidities requiring protected environments and specific medical assistance
- blindness and severe visual disturbances (included severe nystagmus)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Experimental group
A group of pwMS participate in a multidimensional integrate high-motivating rehabilitation program for the change of lifestyle and bad habits.
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The intervention consists in a one-week intensive rehabilitation in which participants underwent to a multidimensional rehabilitation composed by physical rehabilitation, mental wellbeing, a proper diet and engaging physical activity (a sail course).
Digital motivating reinforcements are proposed to the participants with the aim to maintain the correct lifestyle learned in the B-HIPE program.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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FS-36 Health Related Quality of Life (HRQoL)
大体时间：Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
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Questionnaire to Measure Health-Related Quality of Life
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Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
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The Fatigue Severity Scale (FSS)
大体时间：Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
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Questionnaire to Measure the fatigue
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Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
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Food frequency questionnaire (FFQ)
大体时间：Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
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Questionnaire to evaluate usual frequency of foods and beverages
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Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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MSIS29- Multiple Sclerosis Impact Scale
大体时间：Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
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A scale for the evaluation of the impact of MS on day-to-day life
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Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
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MOS Sleep Scale (MOSS)
大体时间：Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
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A scale for the evaluation of the quality and the quantity of sleep
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Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
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Restless Legs Scale (RLS)
大体时间：Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
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A scale for the evaluation of the restless legs syndrome
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Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
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Six minute walking test (6MWT)
大体时间：Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
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An exercise test used to assess aerobic capacity and endurance
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Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
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Hospital Anxiety and Depression Scale (HADS)
大体时间：Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
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A self-assessment scale for detecting states of depression and anxiety
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Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年7月15日
初级完成 (预期的)
2021年12月31日
研究完成 (预期的)
2022年6月30日
研究注册日期
首次提交
2021年4月28日
首先提交符合 QC 标准的
2021年5月5日
首次发布 (实际的)
2021年5月11日
研究记录更新
最后更新发布 (实际的)
2021年5月11日
上次提交的符合 QC 标准的更新
2021年5月5日
最后验证
2021年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.