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

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: B-HIPE (Brief High Impact Preparatory Experience)

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura LM Mendozzi, MD; Phone Number: +39 02 40308571; Email: lmendozzi@dongnocchi.it

Study Locations

• Italy
  • Milan, Italy
    • Recruiting
    • IRCCS Fondazione Don Carlo Gnocchi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Experimental group; 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); 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Fondazione Don Carlo Gnocchi Onlus

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2018
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: April 28, 2021
• First Submitted That Met QC Criteria: May 5, 2021
• First Posted (Actual): May 11, 2021

Study Record Updates

• Last Update Posted (Actual): May 11, 2021
• Last Update Submitted That Met QC Criteria: May 5, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: rehabilitation; adherence; nutrition; multiple sclerosis; motivation; lifestyle
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 07_23/05/2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No