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

2021. szeptember 15. frissítette: 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.

A tanulmány áttekintése

Állapot

Jelentkezés meghívóval

Körülmények

Beavatkozás / kezelés

Részletes leírás

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.

Tanulmány típusa

Beavatkozó

Beiratkozás (Várható)

30

Fázis

  • Nem alkalmazható

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi helyek

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

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

18 év (Felnőtt, Idősebb felnőtt)

Egészséges önkénteseket fogad

Nem

Tanulmányozható nemek

Összes

Leírás

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.

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Kezelés
  • Kiosztás: Véletlenszerűsített
  • Beavatkozó modell: Párhuzamos hozzárendelés
  • Maszkolás: Egyetlen

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Kísérleti: 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.
Viselkedési: 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.
Aktív összehasonlító: 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.
Viselkedési: 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.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
MS Work Difficulties Questionnaire-23
Időkeret: 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
Időkeret: Baseline
Walking distance within six minutes
Baseline
MS Work Difficulties Questionnaire-23
Időkeret: 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
Időkeret: 5 weeks post-test
Walking distance within six minutes
5 weeks post-test
MS Work Difficulties Questionnaire-23
Időkeret: 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
Időkeret: 10 week post-test
Walking distance within six minutes
10 week post-test

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Trunk Impairment Scale Norwegian Version
Időkeret: Baseline
Dynamic sitting balance, 6 items, top score 16.
Baseline
Mini Balance Evaluation Systems Test
Időkeret: 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
Időkeret: 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
Időkeret: Baseline
The monitors measure Physical activity levels (inactive, light, moderate, vigorous) within 7 days
Baseline
Activity monitors outcome 2
Időkeret: Baseline
The monitors measure number of steps within 7 days
Baseline
European Quality of Life 5-Dimension-3 Level
Időkeret: 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
Időkeret: Baseline
Limitations in walking due to MS on 12 items with a scale 1-5, best score 12
Baseline
Multiple Sclerosis Impact Scale-29
Időkeret: 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
Időkeret: baseline
Self reported weight by kilogram
baseline
Height
Időkeret: baseline
Self reported height by centimetre
baseline
age
Időkeret: baseline
Self reported age by years
baseline
Social status
Időkeret: baseline
Self reported social status; married, cohabitant, living alone
baseline
Type of multiple sclerosis
Időkeret: baseline
Self reported main types: relapsing remitting, primary progressive, secondary progressive
baseline
Year of diagnosis multiple sclerosis
Időkeret: baseline
Self reported by year
baseline
Medications
Időkeret: baseline
Self reported by type of medications
baseline
Expanded disability status scale
Időkeret: baseline
Self reported or from journal functional status at last yearly control by a neurologist
baseline
Occupation
Időkeret: baseline
Self reported
baseline
Percentage of work
Időkeret: baseline
Self reported percentage of work the previous month
baseline
Length of education
Időkeret: baseline
Self reported choices: elementary school; high school; bachelor; masters degree; Doctor of philosophy degree
baseline
Trunk Impairment Scale Norwegian Version
Időkeret: 5 weeks post-test
Dynamic sitting balance, 6 items, top score 16.
5 weeks post-test
Mini Balance Evaluation Systems Test
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 5 weeks post-test
Self-perceived health related quality of life regarding
5 weeks post-test
Multiple Sclerosis Walking Scale-12
Időkeret: 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
Időkeret: 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
Időkeret: 5 weeks post-test
Self reported percentage of work
5 weeks post-test
Trunk Impairment Scale Norwegian Version
Időkeret: 10 weeks post-test
Dynamic sitting balance, 6 items, top score 16.
10 weeks post-test
Mini Balance Evaluation Systems Test
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 10 weeks post-test
Self-perceived health related quality of life regarding
10 weeks post-test
Multiple Sclerosis Walking Scale-12
Időkeret: 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
Időkeret: 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
Időkeret: 10 weeks post-test
Self reported percentage of work
10 weeks post-test

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Nordlandssykehuset HF

Együttműködők

Hasselt University
Helse Nord
Nord University

Nyomozók

  • Tanulmányi igazgató: Petter Oien, PhD, Nordlandssykehuset HF

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Tényleges)

2021. augusztus 27.

Elsődleges befejezés (Várható)

2021. december 31.

A tanulmány befejezése (Várható)

2022. augusztus 30.

Tanulmányi regisztráció dátumai

Először benyújtva

2021. augusztus 27.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2021. szeptember 15.

Első közzététel (Tényleges)

2021. szeptember 27.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2021. szeptember 27.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2021. szeptember 15.

Utolsó ellenőrzés

2021. szeptember 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Kulcsszavak

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • CoreDISTparticipation

Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

NEM

Gyógyszer- és eszközinformációk, tanulmányi dokumentumok

Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz

Nem

Egy amerikai FDA által szabályozott eszközterméket tanulmányoz

Nem

Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .

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