Functions, Physical Activity and Employment for Individuals With MS: A Pilot Feasibility Study (CoreDISTp)
Innovative Follow-up Across Health Care Levels to Optimize Functions, Physical Activity and Employment for Individuals With MS: A Pilot Feasibility Study
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Odotettu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
-
-
-
Bodø, Norja
- Physiotherapy department, Nordlandssykehuset HF
-
Bodø, Norja
- Bodø Municipality
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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. |
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.
|
|
Active Comparator: 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.
|
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.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
MS Work Difficulties Questionnaire-23
Aikaikkuna: 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
Aikaikkuna: Baseline
|
Walking distance within six minutes
|
Baseline
|
|
MS Work Difficulties Questionnaire-23
Aikaikkuna: 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
Aikaikkuna: 5 weeks post-test
|
Walking distance within six minutes
|
5 weeks post-test
|
|
MS Work Difficulties Questionnaire-23
Aikaikkuna: 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
Aikaikkuna: 10 week post-test
|
Walking distance within six minutes
|
10 week post-test
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Trunk Impairment Scale Norwegian Version
Aikaikkuna: Baseline
|
Dynamic sitting balance, 6 items, top score 16.
|
Baseline
|
|
Mini Balance Evaluation Systems Test
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: Baseline
|
The monitors measure Physical activity levels (inactive, light, moderate, vigorous) within 7 days
|
Baseline
|
|
Activity monitors outcome 2
Aikaikkuna: Baseline
|
The monitors measure number of steps within 7 days
|
Baseline
|
|
European Quality of Life 5-Dimension-3 Level
Aikaikkuna: 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
Aikaikkuna: Baseline
|
Limitations in walking due to MS on 12 items with a scale 1-5, best score 12
|
Baseline
|
|
Multiple Sclerosis Impact Scale-29
Aikaikkuna: 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
Aikaikkuna: baseline
|
Self reported weight by kilogram
|
baseline
|
|
Height
Aikaikkuna: baseline
|
Self reported height by centimetre
|
baseline
|
|
age
Aikaikkuna: baseline
|
Self reported age by years
|
baseline
|
|
Social status
Aikaikkuna: baseline
|
Self reported social status; married, cohabitant, living alone
|
baseline
|
|
Type of multiple sclerosis
Aikaikkuna: baseline
|
Self reported main types: relapsing remitting, primary progressive, secondary progressive
|
baseline
|
|
Year of diagnosis multiple sclerosis
Aikaikkuna: baseline
|
Self reported by year
|
baseline
|
|
Medications
Aikaikkuna: baseline
|
Self reported by type of medications
|
baseline
|
|
Expanded disability status scale
Aikaikkuna: baseline
|
Self reported or from journal functional status at last yearly control by a neurologist
|
baseline
|
|
Occupation
Aikaikkuna: baseline
|
Self reported
|
baseline
|
|
Percentage of work
Aikaikkuna: baseline
|
Self reported percentage of work the previous month
|
baseline
|
|
Length of education
Aikaikkuna: baseline
|
Self reported choices: elementary school; high school; bachelor; masters degree; Doctor of philosophy degree
|
baseline
|
|
Trunk Impairment Scale Norwegian Version
Aikaikkuna: 5 weeks post-test
|
Dynamic sitting balance, 6 items, top score 16.
|
5 weeks post-test
|
|
Mini Balance Evaluation Systems Test
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 5 weeks post-test
|
Self-perceived health related quality of life regarding
|
5 weeks post-test
|
|
Multiple Sclerosis Walking Scale-12
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 5 weeks post-test
|
Self reported percentage of work
|
5 weeks post-test
|
|
Trunk Impairment Scale Norwegian Version
Aikaikkuna: 10 weeks post-test
|
Dynamic sitting balance, 6 items, top score 16.
|
10 weeks post-test
|
|
Mini Balance Evaluation Systems Test
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 10 weeks post-test
|
Self-perceived health related quality of life regarding
|
10 weeks post-test
|
|
Multiple Sclerosis Walking Scale-12
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 10 weeks post-test
|
Self reported percentage of work
|
10 weeks post-test
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Opintojohtaja: Petter Oien, PhD, Nordlandssykehuset HF
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Odotettu)
Opintojen valmistuminen (Odotettu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- CoreDISTparticipation
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .