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

Not Applicable

• Conditions: Multiple Sclerosis

• 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

Study Timeline

• Study Start: 2018-07-15
• Status Verified: 2021-04
• Study First Submitted: 2021-04-28
• Study First Submitted QC: 2021-05-05
• Last Update Submitted: 2021-05-05
• Study First Posted: 2021-05-11
• Last Update Posted: 2021-05-11
• Primary Completion: 2021-12-31
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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