Multiple Sclerosis
Conditions
Keywords
Physiotherapy, Employment, Physical activity, Health related quality of life, Cost-benefit
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.
Interventions
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.
Sponsors
The Royal Norwegian Ministry of Health
University Hospital of North Norway
Nord University
UiT The Arctic University of Norway
Helgeland Hospital Trust
University of Tasmania
Norwegian Labour and Welfare Administration
Nordlandssykehuset HF
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 67 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
| 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. |
| 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. |
| 6 meter walk test | Baseline, 9, 16 and 52 weeks post baseline | Walking distance (meters) within six minutes |
| 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. |
| 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. |
| 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. |
| 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 |
Countries
Norway
Outcome results
None listed