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

D

Don Carlo Gnocchi Onlus Foundation

Status

Unknown

Conditions

Multiple Sclerosis

Treatments

Behavioral: B-HIPE (Brief High Impact Preparatory Experience)

Study type

Interventional

Funder types

Other

Identifiers

NCT04881422
07_23/05/2018

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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)

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Experimental group
Experimental group
Description:
A group of pwMS participate in a multidimensional integrate high-motivating rehabilitation program for the change of lifestyle and bad habits.
Treatment:
Behavioral: B-HIPE (Brief High Impact Preparatory Experience)

Trial contacts and locations

1

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Central trial contact

Laura LM Mendozzi, MD

Data sourced from clinicaltrials.gov

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