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

Multiple Sclerosis Clinical Trial

Official title:

Sport, Rehabilitation and Nutrition in Multiple Sclerosis: An Innovative Multidisciplinary High Impact Intervention for the Lifestyle Change

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04881422
• Other study ID #: 07_23/05/2018
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2018
• Est. completion date: June 30, 2022

Study information

• Verified date: April 2021
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: Laura LM Mendozzi, MD
• Phone: 02 40308571
• Email: lmendozzi[@]dongnocchi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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.

Locations

Country	Name	City	State
Italy	IRCCS Fondazione Don Carlo Gnocchi	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)