Functions, Physical Activity and Employment for Individuals With MS: A Pilot Feasibility Study
- Conditions
- Multiple Sclerosis
- Interventions
- Behavioral: CoreDISTparticipationBehavioral: Standard care
- Registration Number
- NCT05057338
- Lead Sponsor
- Nordlandssykehuset HF
- Brief Summary
Multiple Sclerosis (MS) is a chronic disease affecting young adults. Impaired balance, walking, reduced physical activity and participation in employment are common, however, less integrated in the health care. The researchers have developed a multidisciplinary intervention and pathway delivered across health care levels targeting the promotion of balance, walking, physical activity and participation in employment. The research team will perform a pilot feasibility Randomized Controlled Trial (RCT) and interviews to investigate the feasibility of the new intervention compared to a standard care for individuals with lower levels of disability.
- Detailed Description
The study addresses core elements in the health services for individuals with MS, constituting approximately 11000 in Norway. The two-armed pilot feasibility-RCT will be performed across the MS-outpatient (MS-OP) clinic, Nordland Hospital Trust, Bodø (NLSH), and in two surrounding municipalities, including 30 employed participants who will be followed for 10-weeks. The new intervention and pathway, CoreDISTparticipation, builds on GroupCoreDIST, which is previously found effective short and long term compared to standard care. CoreDISTparticipation consists of three phases: a) at the MS-OP clinic, in addition to the regular consultations, the patient will have a structured digital conversation with the MS-nurse addressing work related issues and a session with a physiotherapist exploring possibilities for change in balance and walking; b) in the municipality, a physiotherapist will continue exploration of improvements, followed by four weeks of GroupCoreDIST for 60 minutes, 2 times per week supplemented with home exercise programs focusing on balance, walking and physical activity. The participants will have access to exercise programs on videos through an open website at Nord University to digitally support home training.
To promote participation in employment, a structured digital meeting between each patient, the MS-nurse, the patient's employer, and the physiotherapist (who leads the group trainings) will take place in phase b; followed by phase c) which include four weeks of outdoor group based exercises and physical activity led by a physiotherapist, for 60 minutes, 2 times per week supplemented with the same home exercise programs as in phase b.
Evaluation of employment and physical activity will be conducted using an evaluation form.
The control group will receive usual consultations at the MS-OP clinic, as well as a session with a physiotherapist at the MS-OP clinic, exploring possibilities for change in balance and walking. In the municipality the control group will follow standard care (their usual follow-up).
The research team will examine feasibility, preliminary between-group differences regarding balance, walking, physical activity level, health related quality of life and barriers in employment, as well as the users' experiences with participation in the CoreDISTparticipation.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- Diagnosed with MS (Mc Donald's criteria), Expanded Disability Status Scale ≤3.5 (no disability-fully ambulatory with moderate disability), ≥18 years, being employed. By these criteria the study will include individuals most accessible for the intervention and who have the best prospects to maintain/improve balance, walking, physical activity and participation in employment.
- Retired, pregnancy at enrolment, exacerbation within two weeks prior to enrolment and other serious conditions compromising balance, walking or work capacity.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CoreDISTparticipation CoreDISTparticipation a) at the MS-OP clinic, in addition to the regular consultations, the patient will have a structured digital conversation with the MS-nurse addressing work related issues and a session with a physiotherapist exploring possibilities for change in balance and walking; b) in the municipality, a physiotherapist will continue exploration of improvements, followed by four weeks of GroupCoreDIST focusing on balance, walking and physical activity and conducted in groups of 3-5 individuals with MS and led by a physiotherapist. To promote participation in employment, a structured digital meeting between each patient, the MS-nurse, the patient's employer, and the physiotherapist will take place; followed by c) four weeks of outdoor group based exercises and physical activity led by a physiotherapist, complemented with an evaluation form regarding employment and physical activity. Standard care Standard care The control group will receive the usual consultations at the MS-OP clinic including exploration of possibilities for change in balance and walking together with physiotherapist at the MS-OP clinic. The control group will furthermore follow standard care (their usual follow-up) in the municipality.
- Primary Outcome Measures
Name Time Method Six-Minutes Walk Test 10 week post-test Walking distance within six minutes
MS Work Difficulties Questionnaire-23 10 week post-test How frequently individuals with MS perceive psychological/cognitive (11 items)-, physical (8 items)- and external barriers (4 items) related to their current or most recent job, and is scored by a five point scale (best score 0). (Recently translated to Norwegian).
- Secondary Outcome Measures
Name Time Method Occupation baseline Self reported
Mini Balance Evaluation Systems Test 10 weeks post-test Pro-and reactive balance, dual task and involving sit to stand, standing and walking, 14 items on a 3 point with a top score of 28
Trunk Impairment Scale Norwegian Version 10 weeks post-test Dynamic sitting balance, 6 items, top score 16.
Force Platform 10 weeks post-test The force platform measures control in standing: symmetry/asymmetry of weight bearing with eyes open/closed, postural sway of center of pressure, and weight transfer which all together will present an outcome for standing balance.
Activity monitors outcome 1 10 weeks post-test The monitors measure Physical activity levels (inactive, light, moderate, vigorous) within 7 days
Activity monitors outcome 2 10 weeks post-test The monitors measure number of steps within 7 days
European Quality of Life 5-Dimension-3 Level 10 weeks post-test Self-perceived health related quality of life regarding
Multiple Sclerosis Walking Scale-12 10 weeks post-test Limitations in walking due to MS on 12 items with a scale 1-5, best score 12
Multiple Sclerosis Impact Scale-29 10 weeks post-test Self-perceived physical (13 items) and psychological (9 items) impact due to MS on health related quality of life recorded by a five point scale (best score 29)
Weight baseline Self reported weight by kilogram
Height baseline Self reported height by centimetre
age baseline Self reported age by years
Social status baseline Self reported social status; married, cohabitant, living alone
Type of multiple sclerosis baseline Self reported main types: relapsing remitting, primary progressive, secondary progressive
Year of diagnosis multiple sclerosis baseline Self reported by year
Medications baseline Self reported by type of medications
Expanded disability status scale baseline Self reported or from journal functional status at last yearly control by a neurologist
Percentage of work 10 weeks post-test Self reported percentage of work
Length of education baseline Self reported choices: elementary school; high school; bachelor; masters degree; Doctor of philosophy degree
Trial Locations
- Locations (2)
Physiotherapy department, Nordlandssykehuset HF
🇳🇴Bodø, Norway
Bodø Municipality
🇳🇴Bodø, Norway