Clinical trial NCT04881422: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Keywords: lifestyle
multiple sclerosis
nutrition
rehabilitation
motivation
adherence
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2021-05-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: FS-36 Health Related Quality of Life (HRQoL)
timeFrame: Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
measure: The Fatigue Severity Scale (FSS)
timeFrame: Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
measure: Food frequency questionnaire (FFQ)
timeFrame: Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
Secondary outcomes:
measure: MSIS29- Multiple Sclerosis Impact Scale
timeFrame: Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
measure: MOS Sleep Scale (MOSS)
timeFrame: Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
measure: Restless Legs Scale (RLS)
timeFrame: Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
measure: Six minute walking test (6MWT)
timeFrame: Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Fondazione Don Carlo Gnocchi
Study officials:
References: