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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: CoreDISTparticipation; Behavioral: Standard care

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
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.	Behavioral: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nordlandssykehuset HF
• Collaborators: Hasselt University; Helse Nord; Nord University
• Investigators: Study Director: Petter Oien, PhD, Nordlandssykehuset HF

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2021
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): August 30, 2022

Study Registration Dates

• First Submitted: August 27, 2021
• First Submitted That Met QC Criteria: September 15, 2021
• First Posted (Actual): September 27, 2021

Study Record Updates

• Last Update Posted (Actual): September 27, 2021
• Last Update Submitted That Met QC Criteria: September 15, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: physical activity; Multiple sclerosis; walking; Physiotherapy; neurology; balance; employment; coordination of care; MS nurse
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: CoreDISTparticipation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No