- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04881422
Sport, Rehabilitation and Nutrition in Multiple Sclerosis: The LINUS Project
Sport, Rehabilitation and Nutrition in Multiple Sclerosis: An Innovative Multidisciplinary High Impact Intervention for the Lifestyle Change
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Laura LM Mendozzi, MD
- Numéro de téléphone: +39 02 40308571
- E-mail: lmendozzi@dongnocchi.it
Lieux d'étude
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Milan, Italie
- Recrutement
- Irccs Fondazione Don Carlo Gnocchi
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Experimental group
A group of pwMS participate in a multidimensional integrate high-motivating rehabilitation program for the change of lifestyle and bad habits.
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
FS-36 Health Related Quality of Life (HRQoL)
Délai: Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
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Questionnaire to Measure Health-Related Quality of Life
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Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
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The Fatigue Severity Scale (FSS)
Délai: Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
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Questionnaire to Measure the fatigue
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Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
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Food frequency questionnaire (FFQ)
Délai: Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
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Questionnaire to evaluate usual frequency of foods and beverages
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Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
MSIS29- Multiple Sclerosis Impact Scale
Délai: Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
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A scale for the evaluation of the impact of MS on day-to-day life
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Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
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MOS Sleep Scale (MOSS)
Délai: Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
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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)
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Restless Legs Scale (RLS)
Délai: Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
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A scale for the evaluation of the restless legs syndrome
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Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
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Six minute walking test (6MWT)
Délai: Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
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An exercise test used to assess aerobic capacity and endurance
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Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
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Hospital Anxiety and Depression Scale (HADS)
Délai: Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
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A self-assessment scale for detecting states of depression and anxiety
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Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 07_23/05/2018
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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