Physical Function, Health and Employment for People With Multiple Sclerosis

Nordlandssykehuset HF

Status: Active, not recruiting

Conditions: Multiple Sclerosis

Treatments: Other: CoreDISTParticipation

Study type: Interventional

Funder types: Other

Identifiers

NCT06110468

HNF1687-23

Details and patient eligibility

About

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.

Full 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.

Enrollment: 114 estimated patients

Sex: All

Ages: 18 to 67 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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114 participants in 2 patient groups

Intervention, CoreDISTParticpation

Experimental group

Description:

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

Treatment:

Other: CoreDISTParticipation

Control, usual care

No Intervention group

Description:

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.