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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05057338
Acronym
CoreDISTp
Enrollment
30
Registered
2021-09-27
Start date
2021-08-27
Completion date
2022-08-30
Last updated
2021-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis, Physiotherapy, neurology, MS nurse, coordination of care, balance, walking, physical activity, employment

Brief summary

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.

Detailed description

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.

Interventions

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.

BEHAVIORALStandard 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.

Sponsors

Nord University
CollaboratorOTHER
Hasselt University
CollaboratorOTHER
Helse Nord
CollaboratorINDUSTRY
Nordlandssykehuset HF
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Assessor is masked for group allocation

Intervention model description

RCT with two arms: intervention group and control group.

Eligibility

Sex/Gender
ALL
Age
18 Years to 68 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
MS Work Difficulties Questionnaire-23BaselineHow 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).
Six-Minutes Walk TestBaselineWalking distance within six minutes

Secondary

MeasureTime frameDescription
Trunk Impairment Scale Norwegian VersionBaselineDynamic sitting balance, 6 items, top score 16.
Mini Balance Evaluation Systems TestBaselinePro-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
Force PlatformBaselineThe 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.
European Quality of Life 5-Dimension-3 LevelBaselineSelf-perceived health related quality of life regarding five domains, each with three items, and a Visual Analog Scale (0-100) recording perceived health.
Multiple Sclerosis Walking Scale-12BaselineLimitations in walking due to MS on 12 items with a scale 1-5, best score 12
Multiple Sclerosis Impact Scale-29baselineSelf-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)
WeightbaselineSelf reported weight by kilogram
HeightbaselineSelf reported height by centimetre
Activity monitors outcome 1BaselineThe monitors measure Physical activity levels (inactive, light, moderate, vigorous) within 7 days
Social statusbaselineSelf reported social status; married, cohabitant, living alone
Type of multiple sclerosisbaselineSelf reported main types: relapsing remitting, primary progressive, secondary progressive
Year of diagnosis multiple sclerosisbaselineSelf reported by year
MedicationsbaselineSelf reported by type of medications
Expanded disability status scalebaselineSelf reported or from journal functional status at last yearly control by a neurologist
OccupationbaselineSelf reported
Percentage of workbaselineSelf reported percentage of work the previous month
Length of educationbaselineSelf reported choices: elementary school; high school; bachelor; masters degree; Doctor of philosophy degree
agebaselineSelf reported age by years
Activity monitors outcome 2BaselineThe monitors measure number of steps within 7 days

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026