Sport, Rehabilitation and Nutrition in Multiple Sclerosis: The LINUS Project
- Conditions
- Multiple Sclerosis
- Interventions
- Behavioral: B-HIPE (Brief High Impact Preparatory Experience)
- Registration Number
- NCT04881422
- Lead Sponsor
- Fondazione Don Carlo Gnocchi Onlus
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Experimental group B-HIPE (Brief High Impact Preparatory Experience) A group of pwMS participate in a multidimensional integrate high-motivating rehabilitation program for the change of lifestyle and bad habits.
- Primary Outcome Measures
Name Time Method FS-36 Health Related Quality of Life (HRQoL) 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) 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) 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
- Secondary Outcome Measures
Name Time Method MSIS29- Multiple Sclerosis Impact Scale Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1) A scale for the evaluation of the impact of MS on day-to-day life
MOS Sleep Scale (MOSS) Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1) A scale for the evaluation of the quality and the quantity of sleep
Restless Legs Scale (RLS) Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1) A scale for the evaluation of the restless legs syndrome
Six minute walking test (6MWT) Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1) An exercise test used to assess aerobic capacity and endurance
Hospital Anxiety and Depression Scale (HADS) Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1) A self-assessment scale for detecting states of depression and anxiety
Trial Locations
- Locations (1)
IRCCS Fondazione Don Carlo Gnocchi
🇮🇹Milan, Italy