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

5. maj 2021 opdateret af: Fondazione Don Carlo Gnocchi Onlus

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Italien
      • Milan, Italien
        • Rekruttering
        • IRCCS Fondazione Don Carlo Gnocchi

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Experimental group
A group of pwMS participate in a multidimensional integrate high-motivating rehabilitation program for the change of lifestyle and bad habits.
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
FS-36 Health Related Quality of Life (HRQoL)
Tidsramme: 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
Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
The Fatigue Severity Scale (FSS)
Tidsramme: Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
Questionnaire to Measure the fatigue
Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
Food frequency questionnaire (FFQ)
Tidsramme: 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
Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
MSIS29- Multiple Sclerosis Impact Scale
Tidsramme: 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
Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
MOS Sleep Scale (MOSS)
Tidsramme: 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
Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
Restless Legs Scale (RLS)
Tidsramme: 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
Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
Six minute walking test (6MWT)
Tidsramme: 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
Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
Hospital Anxiety and Depression Scale (HADS)
Tidsramme: 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
Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Fondazione Don Carlo Gnocchi Onlus

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. juli 2018

Primær færdiggørelse (Forventet)

31. december 2021

Studieafslutning (Forventet)

30. juni 2022

Datoer for studieregistrering

Først indsendt

28. april 2021

Først indsendt, der opfyldte QC-kriterier

5. maj 2021

Først opslået (Faktiske)

11. maj 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. maj 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. maj 2021

Sidst verificeret

1. april 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 07_23/05/2018

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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