Multiple Sclerosis
Conditions
Keywords
lifestyle, multiple sclerosis, nutrition, rehabilitation, motivation, adherence
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.
Interventions
BEHAVIORALB-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.
Sponsors
Fondazione Don Carlo Gnocchi Onlus
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FS-36 Health Related Quality of Life (HRQoL) | Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1) | Questionnaire to Measure Health-Related Quality of Life |
| The Fatigue Severity Scale (FSS) | Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1) | Questionnaire to Measure the fatigue |
| Food frequency questionnaire (FFQ) | Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1) | Questionnaire to evaluate usual frequency of foods and beverages |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Six minute walking test (6MWT) | Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1) | An exercise test used to assess aerobic capacity and endurance |
| MSIS29- Multiple Sclerosis Impact Scale | Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1) | A scale for the evaluation of the impact of MS on day-to-day life |
| Hospital Anxiety and Depression Scale (HADS) | Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1) | A self-assessment scale for detecting states of depression and anxiety |
| MOS Sleep Scale (MOSS) | Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1) | A scale for the evaluation of the quality and the quantity of sleep |
| Restless Legs Scale (RLS) | Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1) | A scale for the evaluation of the restless legs syndrome |
Countries
Italy
Contacts
Primary ContactLaura LM Mendozzi, MD
Outcome results
None listed