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

NCT05057338 | Unknown

• 1 other identifier: CoreDISTparticipation
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Multiple Sclerosis

Keywords

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

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (37)

• Trunk Impairment Scale Norwegian Version

  Baseline

• Mini Balance Evaluation Systems Test

  Baseline

• Force Platform

  Baseline

• Activity monitors outcome 1

  Baseline

• Activity monitors outcome 2

  Baseline

Study Arms (2)

CoreDISTparticipation

EXPERIMENTAL

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

Standard care

ACTIVE COMPARATOR

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

Interventions

CoreDISTparticipation BEHAVIORAL

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.

CoreDISTparticipation

Standard care BEHAVIORAL

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.

Standard care

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Retired, pregnancy at enrolment, exacerbation within two weeks prior to enrolment and other serious conditions compromising balance, walking or work capacity.

Sponsors & Collaborators

• Nordlandssykehuset HF: lead
• Nord University: collaborator
• Hasselt University: collaborator
• Helse Nord: collaborator

Study Sites (2)

Bodø Municipality

Bodø, Norway

Location

Physiotherapy department, Nordlandssykehuset HF

Bodø, Norway

Location

Related Publications (1)

• Arntzen EC, Braaten T, Fikke HK, Normann B. Feasibility of a new intervention addressing group-based balance and high-intensity training, physical activity, and employment in individuals with multiple sclerosis: a pilot randomized controlled trial. Front Rehabil Sci. 2024 Jan 8;4:1258737. doi: 10.3389/fresc.2023.1258737. eCollection 2023.

  PMID: 38259873 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Petter Oien, PhD

  Nordlandssykehuset HF

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessor is masked for group allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: RCT with two arms: intervention group and control group.

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: September 27, 2021
• Study Start: August 27, 2021
• Primary Completion: December 31, 2021
• Study Completion: August 30, 2022
• Last Updated: September 27, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)