Physical Function, Health and Employment for People With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06110468
• Other study ID #: HNF1687-23
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: December 2035

Study information

• Verified date: October 2023
• Source: Nordlandssykehuset HF
• Contact: Britt Normann, Phd
• Phone: +4799614941
• Email: britt.normann[@]nord.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 114
• Est. completion date: December 2035
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 67 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (8)

Lead Sponsor	Collaborator
Nordlandssykehuset HF	Helgeland Hospital Trust, Nord University, Norwegian Labour and Welfare Administration, The Royal Norwegian Ministry of Health, UiT The Arctic University of Norway, University Hospital of North Norway, University of Tasmania

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	6 meter walk test	Walking distance (meters) within six minutes	Baseline, 9, 16 and 52 weeks post baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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