Sport, Rehabilitation and Nutrition in Multiple Sclerosis: An Innovative Multidisciplinary High Impact Intervention for the Lifestyle Change
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- FS-36 Health Related Quality of Life (HRQoL)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18 to 70 years
- •EDSS ranging from 1 to 7.
- •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
排除标准
- •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)
结局指标
主要结局
FS-36 Health Related Quality of Life (HRQoL)
时间窗: Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
Questionnaire to Measure Health-Related Quality of Life
The Fatigue Severity Scale (FSS)
时间窗: Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
Questionnaire to Measure the fatigue
Food frequency questionnaire (FFQ)
时间窗: Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
Questionnaire to evaluate usual frequency of foods and beverages
次要结局
- MSIS29- Multiple Sclerosis Impact Scale(Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1))
- MOS Sleep Scale (MOSS)(Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1))
- Restless Legs Scale (RLS)(Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1))
- Six minute walking test (6MWT)(Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1))
- Hospital Anxiety and Depression Scale (HADS)(Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1))