Sport, Rehabilitation and Nutrition in Multiple Sclerosis: An Innovative Multidisciplinary High Impact Intervention for the Lifestyle Change
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- FS-36 Health Related Quality of Life (HRQoL)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •aged 18 to 70 years
- •EDSS ranging from 1 to 7.
- •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)
Outcomes
Primary Outcomes
FS-36 Health Related Quality of Life (HRQoL)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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 Outcomes
- MSIS29- Multiple Sclerosis Impact Scale(Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1))
- MOS Sleep Scale (MOSS)(Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1))
- Restless Legs Scale (RLS)(Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1))
- Six minute walking test (6MWT)(Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1))
- Hospital Anxiety and Depression Scale (HADS)(Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1))