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

NCT ID: NCT04881422

Last Updated: 2021-05-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-15
• Study Completion Date: 2022-06-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group

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

Group Type: EXPERIMENTAL

B-HIPE (Brief High Impact Preparatory Experience)

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Don Carlo Gnocchi Onlus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IRCCS Fondazione Don Carlo Gnocchi

Milan, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Laura LM Mendozzi, MD

Role: CONTACT

lmendozzi@dongnocchi.it

02 40308571 ext. +39

Facility Contacts

Laura Mendozzi, MD

Role: primary

lmendozzi@dongnocchi.it

Other Identifiers

07_23/05/2018

Identifier Type: -

Identifier Source: org_study_id