Sport, Rehabilitation and Nutrition in Multiple Sclerosis: The LINUS Project

Study Overview
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Brief Summary
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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.

Official Title
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Sport, Rehabilitation and Nutrition in Multiple Sclerosis: An Innovative Multidisciplinary High Impact Intervention for the Lifestyle Change

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: B-HIPE (Brief High Impact Preparatory Experience)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>A group of pwMS participate in a multidimensional integrate high-motivating rehabilitation program for the change of lifestyle and bad habits. | Behavioral: B-HIPE (Brief High Impact Preparatory Experience)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FS-36 Health Related Quality of Life (HRQoL) | Questionnaire to Measure Health-Related Quality of Life | Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1) | 
| The Fatigue Severity Scale (FSS) | Questionnaire to Measure the fatigue | Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1) | 
| Food frequency questionnaire (FFQ) | Questionnaire to evaluate usual frequency of foods and beverages | Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MSIS29- Multiple Sclerosis Impact Scale | A scale for the evaluation of the impact of MS on day-to-day life | Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1) | 
| MOS Sleep Scale (MOSS) | A scale for the evaluation of the quality and the quantity of sleep | Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1) | 
| Restless Legs Scale (RLS) | A scale for the evaluation of the restless legs syndrome | Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1) | 
| Six minute walking test (6MWT) | An exercise test used to assess aerobic capacity and endurance | Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1) | 
| Hospital Anxiety and Depression Scale (HADS) | A self-assessment scale for detecting states of depression and anxiety | Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lifestyle, multiple sclerosis, nutrition, rehabilitation, motivation, adherence