Physical Function, Health and Employment for People With Multiple Sclerosis

Tailored Follow-up for Persons With Multiple Sclerosis to Optimize Physical Functions, Health and Employment: a Prospective Single-blinded Randomized Controlled Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: CoreDISTParticipation

Detailed Description

Physiotherapy and physical activity interventions can reduce fatigue, improve balance, walking, HRQoL, and may improve neuromuscular and physical functioning in people with MS. However, these interventions lack coordination between health care levels and sectors and rarely address vital employment adaptations. Optimizing function and physical activity, when disability is low and neuroplasticity is optimal, can be valuable for maintaining work as levels of fatigue, mobility related symptoms and cognitive disturbances are associated with current employment.

People with an MS-diagnosis who reside in the North of Norway will be identified from patient lists from the neurological out-patient clinics in the participating hospitals. Upon the provision of written informed consent, all participants will undergo baseline testing prior to randomization into either the intervention or the control group. The intervention group will receive a physiotherapy assessment at the hospitals focusing on opportunities for change. Following this assessment they will participate in group training with a municipality physiotherapist twice weekly for six weeks followed by independent training for six weeks. In addition, both participants and their employers will get access to information films on opportunities for work adaptations and the importance of physical activity. Structured meetings with a specially trained employment consultant, the participant and their employer will be held to discuss possible work adaptations. Goals will be set and formally evaluated. Retests will be carried out at week 9, 16 and 52. Registry data on employment will be obtained from the Norwegian labour and welfare administration as a part of a cost-benefit analysis of the intervention.

• Study Type: Interventional
• Enrollment (Estimated): 114
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Nordland
    • Bodø, Nordland, Norway, 8092
      • Nordlandssykehuset HF

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention, CoreDISTParticpation; 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; 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.
No Intervention: Control, usual care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 meter walk test	Walking distance (meters) within six minutes	Baseline, 9, 16 and 52 weeks post baseline
Step count using ActiGraph wGT3x-BT monitors	Daily average number of steps	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	Self-report, 9 items: physical, social and cognitive effects of fatigue, scale:1-7 (high score indicates higher levels of fatigue).	Baseline, 9, 16 and 52 weeks post baseline
Multiple Sclerosis Walking Scale-12	Self-reported perception of walking, 12 items, score on a 5-point scale. Higher score indicate higher impact of MS on the individuals walking ability.	Baseline, 9, 16 and 52 weeks post baseline
Mini Balance Evaluation Systems Test (MiniBESTest)	Pro-and reactive balance, dual task and involving sit to stand, standing and walking, 14 items on a 3-point scale. Higher score indicate better performance.	Baseline, 9, 16 and 52 weeks post baseline
Trunk Impairment Scale-modified Norwegian version (TISmodNV)	Trunk control in sitting. 6 items, score on a 2- or 3-point scale, sum range 0-16 points. Higher score indicates higher levels of trunk control.	Baseline, 9, 16 and 52 weeks post baseline
Postural control measured by AccuGait Optimized force platforms	Measures postural control in standing, tandem, one-leg standing: postural sway of center of pressure.	Baseline, 9, 16 and 52 weeks post baseline
European Quality of Life 5-Dimension (EQ-5D-5L) + Complementary questions	Self-perceived HRQoL regarding five domains, and a VAS scale (0-100) on overall health. Complementary questions on sleep, wellbeing, emotions, social relations (advocated by the Norwegian Health Institute). Higher score indicate better self-perveived health.	Baseline, 9, 16 and 52 weeks post baseline
Multiple Sclerosis Impact Scale 29-Norwegian version	Self-perceived physical (13 items), psychological (9 items) impact on HRQoL, a 5-point scale. Higher score indicate increased impact of MS on the individuals day-to-day life.	Baseline, 9, 16 and 52 weeks post baseline
Patient Global Impression of Change - physical activity and balance	A global index that is used to rate the response of a condition to a therapy (transition scale). Higher score indicate improvement.	Baseline, 9, 16 and 52 weeks post baseline

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2035

Study Registration Dates

• First Submitted: October 24, 2023
• First Submitted That Met QC Criteria: October 30, 2023
• First Posted (Actual): October 31, 2023

Study Record Updates

• Last Update Posted (Estimated): November 21, 2024
• Last Update Submitted That Met QC Criteria: November 18, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Physical activity; Physiotherapy; Employment; Health related quality of life; Cost-benefit
• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: HNF1687-23

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