Physical Function, Health and Employment for People With Multiple Sclerosis
- Conditions
- Multiple Sclerosis
- Interventions
- Other: CoreDISTParticipation
- Registration Number
- NCT06110468
- Lead Sponsor
- Nordlandssykehuset HF
- 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 114
- 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).
- Pregnancy at enrolment.
- Exacerbation of symptoms (i.e. relapse) within two weeks prior to enrolment.
- Other serious conditions.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention, CoreDISTParticpation CoreDISTParticipation 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
- Primary Outcome Measures
Name Time Method Multiple Sclerosis Work Difficulties Questionnaire -23 Norwegian version Baseline, 9, 16 and 52 weeks post baseline 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).
Levels of physical activity measured 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 % of time in mild, moderate, intensive physical activity and sedate time
- Secondary Outcome Measures
Name Time Method Trunk Impairment Scale-modified Norwegian version (TISmodNV) Baseline, 9, 16 and 52 weeks post baseline 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.
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 Daily average number of steps
Fatigue Severity Scale -Norwegian version Baseline, 9, 16 and 52 weeks post baseline Self-report, 9 items: physical, social and cognitive effects of fatigue, scale:1-7 (high score indicates higher levels of fatigue).
Mini Balance Evaluation Systems Test (MiniBESTest) Baseline, 9, 16 and 52 weeks post baseline 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.
Postural control measured by AccuGait Optimized force platforms Baseline, 9, 16 and 52 weeks post baseline Measures postural control in standing, tandem, one-leg standing: postural sway of center of pressure.
European Quality of Life 5-Dimension (EQ-5D-5L) + Complementary questions Baseline, 9, 16 and 52 weeks post baseline 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.6 meter walk test Baseline, 9, 16 and 52 weeks post baseline Walking distance (meters) within six minutes
Multiple Sclerosis Walking Scale-12 Baseline, 9, 16 and 52 weeks post baseline 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.
Multiple Sclerosis Impact Scale 29-Norwegian version Baseline, 9, 16 and 52 weeks post baseline 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.
Patient Global Impression of Change - physical activity and balance Baseline, 9, 16 and 52 weeks post baseline A global index that is used to rate the response of a condition to a therapy (transition scale). Higher score indicate improvement.
Trial Locations
- Locations (1)
Nordlandssykehuset HF
🇳🇴Bodø, Nordland, Norway