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

NCT04881422 | Unknown

• 1 other identifier: 07_23/05/2018
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

lifestyle; multiple sclerosis; nutrition; rehabilitation; motivation; adherence

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• 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)

Study Arms (1)

Experimental group

EXPERIMENTAL

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)

Interventions

B-HIPE (Brief High Impact Preparatory Experience) BEHAVIORAL

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.

Experimental group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (1)

IRCCS Fondazione Don Carlo Gnocchi

Milan, Italy

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Laura LM Mendozzi, MD

CONTACT

02 40308571; lmendozzi@dongnocchi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 11, 2021
• Study Start: July 15, 2018
• Primary Completion: December 31, 2021
• Study Completion: June 30, 2022
• Last Updated: May 11, 2021

Record last verified: 2021-04

Locations

IT (1)