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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: CoreDISTparticipation
* Behavioral: Standard care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 68 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: RCT with two arms: intervention group and control group.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CoreDISTparticipation<br>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. | Behavioral: CoreDISTparticipation<br>* 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.<br>|
| Active Comparator: Standard care<br>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. | Behavioral: Standard care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MS Work Difficulties Questionnaire-23 | 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 | Walking distance within six minutes | Baseline | 
| MS Work Difficulties Questionnaire-23 | 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 | Walking distance within six minutes | 5 weeks post-test | 
| MS Work Difficulties Questionnaire-23 | 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 | Walking distance within six minutes | 10 week post-test | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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employment, Multiple sclerosis, Physiotherapy, neurology, MS nurse, coordination of care, balance, walking, physical activity