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

Primary Purpose

Multiple Sclerosis

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
B-HIPE (Brief High Impact Preparatory Experience)
Sponsored by
Fondazione Don Carlo Gnocchi Onlus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring lifestyle, multiple sclerosis, nutrition, rehabilitation, motivation, adherence

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • IRCCS Fondazione Don Carlo GnocchiRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental group

Arm Description

A group of pwMS participate in a multidimensional integrate high-motivating rehabilitation program for the change of lifestyle and bad habits.

Outcomes

Primary Outcome Measures

FS-36 Health Related Quality of Life (HRQoL)
Questionnaire to Measure Health-Related Quality of Life
The Fatigue Severity Scale (FSS)
Questionnaire to Measure the fatigue
Food frequency questionnaire (FFQ)
Questionnaire to evaluate usual frequency of foods and beverages

Secondary Outcome Measures

MSIS29- Multiple Sclerosis Impact Scale
A scale for the evaluation of the impact of MS on day-to-day life
MOS Sleep Scale (MOSS)
A scale for the evaluation of the quality and the quantity of sleep
Restless Legs Scale (RLS)
A scale for the evaluation of the restless legs syndrome
Six minute walking test (6MWT)
An exercise test used to assess aerobic capacity and endurance
Hospital Anxiety and Depression Scale (HADS)
A self-assessment scale for detecting states of depression and anxiety

Full Information

First Posted
April 28, 2021
Last Updated
May 5, 2021
Sponsor
Fondazione Don Carlo Gnocchi Onlus
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1. Study Identification

Unique Protocol Identification Number
NCT04881422
Brief Title
Sport, Rehabilitation and Nutrition in Multiple Sclerosis: The LINUS Project
Official Title
Sport, Rehabilitation and Nutrition in Multiple Sclerosis: An Innovative Multidisciplinary High Impact Intervention for the Lifestyle Change
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 15, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Don Carlo Gnocchi Onlus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
lifestyle, multiple sclerosis, nutrition, rehabilitation, motivation, adherence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
A group of pwMS participate in a multidimensional integrate high-motivating rehabilitation program for the change of lifestyle and bad habits.
Intervention Type
Behavioral
Intervention Name(s)
B-HIPE (Brief High Impact Preparatory Experience)
Intervention Description
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.
Primary Outcome Measure Information:
Title
FS-36 Health Related Quality of Life (HRQoL)
Description
Questionnaire to Measure Health-Related Quality of Life
Time Frame
Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
Title
The Fatigue Severity Scale (FSS)
Description
Questionnaire to Measure the fatigue
Time Frame
Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
Title
Food frequency questionnaire (FFQ)
Description
Questionnaire to evaluate usual frequency of foods and beverages
Time Frame
Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
Secondary Outcome Measure Information:
Title
MSIS29- Multiple Sclerosis Impact Scale
Description
A scale for the evaluation of the impact of MS on day-to-day life
Time Frame
Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
Title
MOS Sleep Scale (MOSS)
Description
A scale for the evaluation of the quality and the quantity of sleep
Time Frame
Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
Title
Restless Legs Scale (RLS)
Description
A scale for the evaluation of the restless legs syndrome
Time Frame
Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
Title
Six minute walking test (6MWT)
Description
An exercise test used to assess aerobic capacity and endurance
Time Frame
Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
Title
Hospital Anxiety and Depression Scale (HADS)
Description
A self-assessment scale for detecting states of depression and anxiety
Time Frame
Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura LM Mendozzi, MD
Phone
02 40308571
Ext
+39
Email
lmendozzi@dongnocchi.it
Facility Information:
Facility Name
IRCCS Fondazione Don Carlo Gnocchi
City
Milan
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Mendozzi, MD
Email
lmendozzi@dongnocchi.it

12. IPD Sharing Statement

Learn more about this trial

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

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