Physical Function, Health and Employment for People With Multiple Sclerosis

NCT06110468 | Active Not Recruiting

• 1 other identifier: HNF1687-23
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

Employment is low in people with MS, even when physical levels of functioning are high. The purpose of this study is to investigate if an individually tailored intervention combining individualized physiotherapy and work adaptation works better than usual care in terms of reducing barriers for work and improving levels of physical activity. The utility of the intervention will be investigated in terms of quality adjusted life years, long-term employment status and work-related costs.

Conditions

Multiple Sclerosis

Keywords

Physiotherapy; Employment; Physical activity; Health related quality of life; Cost-benefit

Outcome Measures

Primary Outcomes (2)

• Multiple Sclerosis Work Difficulties Questionnaire -23 Norwegian version

  How frequently individuals with MS perceive psychological/cognitive (11 items), physical (8 items), external, (4 items) barriers related to work, scored by a 5-point scale (0=best).

  Baseline, 9, 16 and 52 weeks post baseline

• Levels of physical activity measured using ActiGraph wGT3x-BT monitors

  % of time in mild, moderate, intensive physical activity and sedate time

  Participants will wear device for one week after testing at baseline and at 9, 16 and 52 weeks post baseline

Secondary Outcomes (10)

• 6 meter walk test

  Baseline, 9, 16 and 52 weeks post baseline

• Step count using ActiGraph wGT3x-BT monitors

  Participants will wear device for one week after testing at baseline and at 9, 16 and 52 weeks post baseline

• Fatigue Severity Scale -Norwegian version

  Baseline, 9, 16 and 52 weeks post baseline

• Multiple Sclerosis Walking Scale-12

  Baseline, 9, 16 and 52 weeks post baseline

• Mini Balance Evaluation Systems Test (MiniBESTest)

  Baseline, 9, 16 and 52 weeks post baseline

Study Arms (2)

Intervention, CoreDISTParticpation

EXPERIMENTAL

Week 1-2: a)Videos for PwMS and employers on MS, possible work adaptations, physical activity (PA) and function. b)A meeting between PwMS and a work-consultant (WC). They will decide if the PwMS should discuss the work situation with their employer or if the WC and/or other professionals are needed. c)A clinical assessment with a trained MS-OP-PT to explore possibilities for optimalisation of movement. Week 3-8: a)A clinical assessment with the mPT building on previous assessment. Goal-setting for function and PA. b)CoreDIST-training in groups, 6 weeks, 1/week. indoors and 1/week outdoors. Independent training 1/week, CoreDISTvideos. c)A follow up meeting regarding work, evaluation of goals with mPT. New goal setting for week 10-15 Week 10-15, Self-administered, digitally supported home training: a)CoreDIST-videos 3x10 min/week b)Training of own choice including elements of high intensity and balance 2x30 minutes per week. c)Week 15: Evaluation of goals regarding work and PA

Other: CoreDISTParticipation

Control, usual care

NO INTERVENTION

Usual care (control group): These participants will continue with their regular routines and will be encouraged to obtain the national and MS-specific recommendation of 150-300 minutes of moderate physical activity or 75 minutes of high intensity physical activity per week or a combination of these, stay employed, continue medical treatment and seek any health care required, including physiotherapy.

Interventions

CoreDISTParticipation OTHER

CoreDISTparticipation is a multi-disciplinary individualized intervention that concurrently combine 1) providing PwMS and their employers with information on MS, possibilities for work-adaptations within the welfare system and the importance of physical activity 2) Structured goal-setting regarding reducing barriers for work and regarding physical function and activity for PwMS 3) A physiotherapy intervention focusing on improving the underlying prerequisites for balance and walking along with high intensive training and promotion of physical activity 4) structured evaluation and adjustment of goals.

Intervention, CoreDISTParticpation

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with Multiple Sclerosis according to the McDonald's criteria
• Extended Disability Status Scale (EDSS) 0-4
• Being employed, part time or full time, may include various degrees of sick leave, disability pension or AAP.
• Living in the participating 18 municipalities (Hammerfest, Alta, Senja, Målselv, Tromsø, Harstad, Narvik, Fauske, Bodø, Meløy, Vågan, Vestvågøy, Sortland, Hadsel, Rana, Vefsn, Alstadhaug, Brønnøy).

You may not qualify if:

• Pregnancy at enrolment.
• Exacerbation of symptoms (i.e. relapse) within two weeks prior to enrolment.
• Other serious conditions.

Sponsors & Collaborators

• Nordlandssykehuset HF: lead
• The Royal Norwegian Ministry of Health: collaborator
• University Hospital of North Norway: collaborator
• Nord University: collaborator
• UiT The Arctic University of Norway: collaborator
• Helgeland Hospital Trust: collaborator
• University of Tasmania: collaborator
• Norwegian Labour and Welfare Administration: collaborator

Study Sites (1)

Nordlandssykehuset HF

Bodø, Nordland, 8092, Norway

Location

Related Publications (1)

• Normann B, Sivertsen M, Braaten TB, Melberg HO, Fikke HK, Elvik M, Arntzen EC. A Comprehensive and Structured Follow-Up for Persons With Multiple Sclerosis (CoreDISTparticipation) to Optimize Physical Functions, Health, and Employment: Protocol for a Prospective, Single-Blinded Randomized Controlled Trial and Health Economic Evaluation. JMIR Res Protoc. 2025 Oct 8;14:e74988. doi: 10.2196/74988.

  PMID: 41061251 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: October 31, 2023
• Study Start: March 4, 2024
• Primary Completion: December 1, 2024
• Study Completion (Estimated): December 1, 2035
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)