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Functions, Physical Activity and Employment for Individuals With MS: A Pilot Feasibility Study (CoreDISTp)

15 settembre 2021 aggiornato da: Nordlandssykehuset HF

Innovative Follow-up Across Health Care Levels to Optimize Functions, Physical Activity and Employment for Individuals With MS: A Pilot Feasibility Study

Multiple Sclerosis (MS) is a chronic disease affecting young adults. Impaired balance, walking, reduced physical activity and participation in employment are common, however, less integrated in the health care. The researchers have developed a multidisciplinary intervention and pathway delivered across health care levels targeting the promotion of balance, walking, physical activity and participation in employment. The research team will perform a pilot feasibility Randomized Controlled Trial (RCT) and interviews to investigate the feasibility of the new intervention compared to a standard care for individuals with lower levels of disability.

Panoramica dello studio

Stato

Iscrizione su invito

Condizioni

Intervento / Trattamento

Descrizione dettagliata

The study addresses core elements in the health services for individuals with MS, constituting approximately 11000 in Norway. The two-armed pilot feasibility-RCT will be performed across the MS-outpatient (MS-OP) clinic, Nordland Hospital Trust, Bodø (NLSH), and in two surrounding municipalities, including 30 employed participants who will be followed for 10-weeks. The new intervention and pathway, CoreDISTparticipation, builds on GroupCoreDIST, which is previously found effective short and long term compared to standard care. CoreDISTparticipation consists of three phases: a) at the MS-OP clinic, in addition to the regular consultations, the patient will have a structured digital conversation with the MS-nurse addressing work related issues and a session with a physiotherapist exploring possibilities for change in balance and walking; b) in the municipality, a physiotherapist will continue exploration of improvements, followed by four weeks of GroupCoreDIST for 60 minutes, 2 times per week supplemented with home exercise programs focusing on balance, walking and physical activity. The participants will have access to exercise programs on videos through an open website at Nord University to digitally support home training.

To promote participation in employment, a structured digital meeting between each patient, the MS-nurse, the patient's employer, and the physiotherapist (who leads the group trainings) will take place in phase b; followed by phase c) which include four weeks of outdoor group based exercises and physical activity led by a physiotherapist, for 60 minutes, 2 times per week supplemented with the same home exercise programs as in phase b.

Evaluation of employment and physical activity will be conducted using an evaluation form.

The control group will receive usual consultations at the MS-OP clinic, as well as a session with a physiotherapist at the MS-OP clinic, exploring possibilities for change in balance and walking. In the municipality the control group will follow standard care (their usual follow-up).

The research team will examine feasibility, preliminary between-group differences regarding balance, walking, physical activity level, health related quality of life and barriers in employment, as well as the users' experiences with participation in the CoreDISTparticipation.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

30

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Norvegia
      • Bodø, Norvegia
        • Physiotherapy department, Nordlandssykehuset HF
      • Bodø, Norvegia
        • Bodø Municipality

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 68 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Diagnosed with MS (Mc Donald's criteria), Expanded Disability Status Scale ≤3.5 (no disability-fully ambulatory with moderate disability), ≥18 years, being employed. By these criteria the study will include individuals most accessible for the intervention and who have the best prospects to maintain/improve balance, walking, physical activity and participation in employment.

Exclusion Criteria:

  • Retired, pregnancy at enrolment, exacerbation within two weeks prior to enrolment and other serious conditions compromising balance, walking or work capacity.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: CoreDISTparticipation

a) at the MS-OP clinic, in addition to the regular consultations, the patient will have a structured digital conversation with the MS-nurse addressing work related issues and a session with a physiotherapist exploring possibilities for change in balance and walking; b) in the municipality, a physiotherapist will continue exploration of improvements, followed by four weeks of GroupCoreDIST focusing on balance, walking and physical activity and conducted in groups of 3-5 individuals with MS and led by a physiotherapist.

To promote participation in employment, a structured digital meeting between each patient, the MS-nurse, the patient's employer, and the physiotherapist will take place; followed by c) four weeks of outdoor group based exercises and physical activity led by a physiotherapist, complemented with an evaluation form regarding employment and physical activity.
Comportamentale: CoreDISTparticipation
CoreDISTparticipation is a thorough intervention that contains coordination of services (physiotherapy, MS-nursing and work adaptations) between the MS-OP clinic and the municipality aiming to improve function, physical activity and employment in individuals with MS.
Comparatore attivo: Standard care
The control group will receive the usual consultations at the MS-OP clinic including exploration of possibilities for change in balance and walking together with physiotherapist at the MS-OP clinic. The control group will furthermore follow standard care (their usual follow-up) in the municipality.
Comportamentale: Standard care
The standard care group will follow regular consultations at the MS-outpatient clinic including a session with the physiotherapist. Furthermore, this group will follow usual care in the municipality which might include other forms of physiotherapy or physical activity. These will be registered.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
MS Work Difficulties Questionnaire-23
Lasso di tempo: Baseline
How frequently individuals with MS perceive psychological/cognitive (11 items)-, physical (8 items)- and external barriers (4 items) related to their current or most recent job, and is scored by a five point scale (best score 0). (Recently translated to Norwegian).
Baseline
Six-Minutes Walk Test
Lasso di tempo: Baseline
Walking distance within six minutes
Baseline
MS Work Difficulties Questionnaire-23
Lasso di tempo: 5 weeks post-test
How frequently individuals with MS perceive psychological/cognitive (11 items)-, physical (8 items)- and external barriers (4 items) related to their current or most recent job, and is scored by a five point scale (best score 0). (Recently translated to Norwegian).
5 weeks post-test
Six-Minutes Walk Test
Lasso di tempo: 5 weeks post-test
Walking distance within six minutes
5 weeks post-test
MS Work Difficulties Questionnaire-23
Lasso di tempo: 10 week post-test
How frequently individuals with MS perceive psychological/cognitive (11 items)-, physical (8 items)- and external barriers (4 items) related to their current or most recent job, and is scored by a five point scale (best score 0). (Recently translated to Norwegian).
10 week post-test
Six-Minutes Walk Test
Lasso di tempo: 10 week post-test
Walking distance within six minutes
10 week post-test

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Trunk Impairment Scale Norwegian Version
Lasso di tempo: Baseline
Dynamic sitting balance, 6 items, top score 16.
Baseline
Mini Balance Evaluation Systems Test
Lasso di tempo: Baseline
Pro-and reactive balance, dual task and involving sit to stand, standing and walking, 14 items on a 3 point with a top score of 28
Baseline
Force Platform
Lasso di tempo: Baseline
The force platform measures control in standing: symmetry/asymmetry of weight bearing with eyes open/closed, postural sway of center of pressure, and weight transfer which all together will present an outcome for standing balance.
Baseline
Activity monitors outcome 1
Lasso di tempo: Baseline
The monitors measure Physical activity levels (inactive, light, moderate, vigorous) within 7 days
Baseline
Activity monitors outcome 2
Lasso di tempo: Baseline
The monitors measure number of steps within 7 days
Baseline
European Quality of Life 5-Dimension-3 Level
Lasso di tempo: Baseline
Self-perceived health related quality of life regarding five domains, each with three items, and a Visual Analog Scale (0-100) recording perceived health.
Baseline
Multiple Sclerosis Walking Scale-12
Lasso di tempo: Baseline
Limitations in walking due to MS on 12 items with a scale 1-5, best score 12
Baseline
Multiple Sclerosis Impact Scale-29
Lasso di tempo: baseline
Self-perceived physical (13 items) and psychological (9 items) impact due to MS on health related quality of life recorded by a five point scale (best score 29)
baseline
Weight
Lasso di tempo: baseline
Self reported weight by kilogram
baseline
Height
Lasso di tempo: baseline
Self reported height by centimetre
baseline
age
Lasso di tempo: baseline
Self reported age by years
baseline
Social status
Lasso di tempo: baseline
Self reported social status; married, cohabitant, living alone
baseline
Type of multiple sclerosis
Lasso di tempo: baseline
Self reported main types: relapsing remitting, primary progressive, secondary progressive
baseline
Year of diagnosis multiple sclerosis
Lasso di tempo: baseline
Self reported by year
baseline
Medications
Lasso di tempo: baseline
Self reported by type of medications
baseline
Expanded disability status scale
Lasso di tempo: baseline
Self reported or from journal functional status at last yearly control by a neurologist
baseline
Occupation
Lasso di tempo: baseline
Self reported
baseline
Percentage of work
Lasso di tempo: baseline
Self reported percentage of work the previous month
baseline
Length of education
Lasso di tempo: baseline
Self reported choices: elementary school; high school; bachelor; masters degree; Doctor of philosophy degree
baseline
Trunk Impairment Scale Norwegian Version
Lasso di tempo: 5 weeks post-test
Dynamic sitting balance, 6 items, top score 16.
5 weeks post-test
Mini Balance Evaluation Systems Test
Lasso di tempo: 5 weeks post-test
Pro-and reactive balance, dual task and involving sit to stand, standing and walking, 14 items on a 3 point with a top score of 28
5 weeks post-test
Force Platform
Lasso di tempo: 5 weeks post-test
The force platform measures control in standing: symmetry/asymmetry of weight bearing with eyes open/closed, postural sway of center of pressure, and weight transfer which all together will present an outcome for standing balance.
5 weeks post-test
Activity monitors outcome 1
Lasso di tempo: 5 weeks post-test
The monitors measure Physical activity levels (inactive, light, moderate, vigorous) within 7 days
5 weeks post-test
Activity monitors outcome 2
Lasso di tempo: 5 weeks post-test
The monitors measure number of steps within 7 days
5 weeks post-test
European Quality of Life 5-Dimension-3 Level
Lasso di tempo: 5 weeks post-test
Self-perceived health related quality of life regarding
5 weeks post-test
Multiple Sclerosis Walking Scale-12
Lasso di tempo: 5 weeks post-test
Limitations in walking due to MS on 12 items with a scale 1-5, best score 12
5 weeks post-test
Multiple Sclerosis Impact Scale-29
Lasso di tempo: 5 weeks post-test
Self-perceived physical (13 items) and psychological (9 items) impact due to MS on health related quality of life recorded by a five point scale (best score 29)
5 weeks post-test
Percentage of work
Lasso di tempo: 5 weeks post-test
Self reported percentage of work
5 weeks post-test
Trunk Impairment Scale Norwegian Version
Lasso di tempo: 10 weeks post-test
Dynamic sitting balance, 6 items, top score 16.
10 weeks post-test
Mini Balance Evaluation Systems Test
Lasso di tempo: 10 weeks post-test
Pro-and reactive balance, dual task and involving sit to stand, standing and walking, 14 items on a 3 point with a top score of 28
10 weeks post-test
Force Platform
Lasso di tempo: 10 weeks post-test
The force platform measures control in standing: symmetry/asymmetry of weight bearing with eyes open/closed, postural sway of center of pressure, and weight transfer which all together will present an outcome for standing balance.
10 weeks post-test
Activity monitors outcome 1
Lasso di tempo: 10 weeks post-test
The monitors measure Physical activity levels (inactive, light, moderate, vigorous) within 7 days
10 weeks post-test
Activity monitors outcome 2
Lasso di tempo: 10 weeks post-test
The monitors measure number of steps within 7 days
10 weeks post-test
European Quality of Life 5-Dimension-3 Level
Lasso di tempo: 10 weeks post-test
Self-perceived health related quality of life regarding
10 weeks post-test
Multiple Sclerosis Walking Scale-12
Lasso di tempo: 10 weeks post-test
Limitations in walking due to MS on 12 items with a scale 1-5, best score 12
10 weeks post-test
Multiple Sclerosis Impact Scale-29
Lasso di tempo: 10 weeks post-test
Self-perceived physical (13 items) and psychological (9 items) impact due to MS on health related quality of life recorded by a five point scale (best score 29)
10 weeks post-test
Percentage of work
Lasso di tempo: 10 weeks post-test
Self reported percentage of work
10 weeks post-test

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Nordlandssykehuset HF

Collaboratori

Hasselt University
Helse Nord
Nord University

Investigatori

  • Direttore dello studio: Petter Oien, PhD, Nordlandssykehuset HF

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

27 agosto 2021

Completamento primario (Anticipato)

31 dicembre 2021

Completamento dello studio (Anticipato)

30 agosto 2022

Date di iscrizione allo studio

Primo inviato

27 agosto 2021

Primo inviato che soddisfa i criteri di controllo qualità

15 settembre 2021

Primo Inserito (Effettivo)

27 settembre 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

27 settembre 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 settembre 2021

Ultimo verificato

1 settembre 2021

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CoreDISTparticipation

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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