Clinical trial NCT05057338: Functions, Physical Activity and Employment for Individuals With MS: A Pilot Feasibility Study
Official title: Innovative Follow-up Across Health Care Levels to Optimize Functions, Physical Activity and Employment for Individuals With MS: A Pilot Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis
Physiotherapy
neurology
MS nurse
coordination of care
balance
walking
physical activity
employment
Lead sponsor: Nordlandssykehuset HF
Sponsor class: OTHER
Collaborators: name: Nord University
name: Hasselt University
name: Helse Nord
First posted: 2021-09-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT with two arms: intervention group and control group.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Retired, pregnancy at enrolment, exacerbation within two weeks prior to enrolment and other serious conditions compromising balance, walking or work capacity.

Primary outcomes:
measure: MS Work Difficulties Questionnaire-23
timeFrame: Baseline
measure: Six-Minutes Walk Test
timeFrame: Baseline
measure: MS Work Difficulties Questionnaire-23
timeFrame: 5 weeks post-test
measure: Six-Minutes Walk Test
timeFrame: 5 weeks post-test
measure: MS Work Difficulties Questionnaire-23
timeFrame: 10 week post-test
measure: Six-Minutes Walk Test
timeFrame: 10 week post-test
Secondary outcomes:
measure: Trunk Impairment Scale Norwegian Version
timeFrame: Baseline
measure: Mini Balance Evaluation Systems Test
timeFrame: Baseline
measure: Force Platform
timeFrame: Baseline
measure: Activity monitors outcome 1
timeFrame: Baseline
measure: Activity monitors outcome 2
timeFrame: Baseline
measure: European Quality of Life 5-Dimension-3 Level
timeFrame: Baseline
measure: Multiple Sclerosis Walking Scale-12
timeFrame: Baseline
measure: Multiple Sclerosis Impact Scale-29
timeFrame: baseline
measure: Weight
timeFrame: baseline
measure: Height
timeFrame: baseline
measure: age
timeFrame: baseline
measure: Social status
timeFrame: baseline
measure: Type of multiple sclerosis
timeFrame: baseline
measure: Year of diagnosis multiple sclerosis
timeFrame: baseline
measure: Medications
timeFrame: baseline
measure: Expanded disability status scale
timeFrame: baseline
measure: Occupation
timeFrame: baseline
measure: Percentage of work
timeFrame: baseline
measure: Length of education
timeFrame: baseline
measure: Trunk Impairment Scale Norwegian Version
timeFrame: 5 weeks post-test
measure: Mini Balance Evaluation Systems Test
timeFrame: 5 weeks post-test
measure: Force Platform
timeFrame: 5 weeks post-test
measure: Activity monitors outcome 1
timeFrame: 5 weeks post-test
measure: Activity monitors outcome 2
timeFrame: 5 weeks post-test
measure: European Quality of Life 5-Dimension-3 Level
timeFrame: 5 weeks post-test
measure: Multiple Sclerosis Walking Scale-12
timeFrame: 5 weeks post-test
measure: Multiple Sclerosis Impact Scale-29
timeFrame: 5 weeks post-test
measure: Percentage of work
timeFrame: 5 weeks post-test
measure: Trunk Impairment Scale Norwegian Version
timeFrame: 10 weeks post-test
measure: Mini Balance Evaluation Systems Test
timeFrame: 10 weeks post-test
measure: Force Platform
timeFrame: 10 weeks post-test
measure: Activity monitors outcome 1
timeFrame: 10 weeks post-test
measure: Activity monitors outcome 2
timeFrame: 10 weeks post-test
measure: European Quality of Life 5-Dimension-3 Level
timeFrame: 10 weeks post-test
measure: Multiple Sclerosis Walking Scale-12
timeFrame: 10 weeks post-test
measure: Multiple Sclerosis Impact Scale-29
timeFrame: 10 weeks post-test
measure: Percentage of work
timeFrame: 10 weeks post-test
Other outcomes:
Locations:
city: Bodø
country: Norway
facility: Bodø Municipality
city: Bodø
country: Norway
facility: Physiotherapy department, Nordlandssykehuset HF
Study officials:
affiliation: Nordlandssykehuset HF
name: Petter Oien, PhD
role: STUDY_DIRECTOR
References: