Functions, Physical Activity and Employment for Individuals With MS: A Pilot Feasibility Study

Multiple Sclerosis Clinical Trial

— CoreDISTp  

Official title:

Innovative Follow-up Across Health Care Levels to Optimize Functions, Physical Activity and Employment for Individuals With MS: A Pilot Feasibility Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05057338
• Other study ID #: CoreDISTparticipation
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 27, 2021
• Est. completion date: August 30, 2022

Study information

• Verified date: September 2021
• Source: Nordlandssykehuset HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: August 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 68 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• CoreDISTparticipation
CoreDISTparticipation is a thorough intervention that contains coordination of services (physiotherapy, MS-nursing and work adaptations) between the MS-OP clinic and the municipality aiming to improve function, physical activity and employment in individuals with MS.
• Standard care
The standard care group will follow regular consultations at the MS-outpatient clinic including a session with the physiotherapist. Furthermore, this group will follow usual care in the municipality which might include other forms of physiotherapy or physical activity. These will be registered.

Locations

Country	Name	City	State
Norway	Bodø Municipality	Bodø
Norway	Physiotherapy department, Nordlandssykehuset HF	Bodø

Sponsors (4)

Lead Sponsor	Collaborator
Nordlandssykehuset HF	Hasselt University, Helse Nord, Nord University

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MS Work Difficulties Questionnaire-23	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).	Baseline
Primary	Six-Minutes Walk Test	Walking distance within six minutes	Baseline
Primary	MS Work Difficulties Questionnaire-23	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).	5 weeks post-test
Primary	Six-Minutes Walk Test	Walking distance within six minutes	5 weeks post-test
Primary	MS Work Difficulties Questionnaire-23	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).	10 week post-test
Primary	Six-Minutes Walk Test	Walking distance within six minutes	10 week post-test
Secondary	Trunk Impairment Scale Norwegian Version	Dynamic sitting balance, 6 items, top score 16.	Baseline
Secondary	Mini Balance Evaluation Systems 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	Baseline
Secondary	Force Platform	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.	Baseline
Secondary	Activity monitors outcome 1	The monitors measure Physical activity levels (inactive, light, moderate, vigorous) within 7 days	Baseline
Secondary	Activity monitors outcome 2	The monitors measure number of steps within 7 days	Baseline
Secondary	European Quality of Life 5-Dimension-3 Level	Self-perceived health related quality of life regarding five domains, each with three items, and a Visual Analog Scale (0-100) recording perceived health.	Baseline
Secondary	Multiple Sclerosis Walking Scale-12	Limitations in walking due to MS on 12 items with a scale 1-5, best score 12	Baseline
Secondary	Multiple Sclerosis Impact Scale-29	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)	baseline
Secondary	Weight	Self reported weight by kilogram	baseline
Secondary	Height	Self reported height by centimetre	baseline
Secondary	age	Self reported age by years	baseline
Secondary	Social status	Self reported social status; married, cohabitant, living alone	baseline
Secondary	Type of multiple sclerosis	Self reported main types: relapsing remitting, primary progressive, secondary progressive	baseline
Secondary	Year of diagnosis multiple sclerosis	Self reported by year	baseline
Secondary	Medications	Self reported by type of medications	baseline
Secondary	Expanded disability status scale	Self reported or from journal functional status at last yearly control by a neurologist	baseline
Secondary	Occupation	Self reported	baseline
Secondary	Percentage of work	Self reported percentage of work the previous month	baseline
Secondary	Length of education	Self reported choices: elementary school; high school; bachelor; masters degree; Doctor of philosophy degree	baseline
Secondary	Trunk Impairment Scale Norwegian Version	Dynamic sitting balance, 6 items, top score 16.	5 weeks post-test
Secondary	Mini Balance Evaluation Systems 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	5 weeks post-test
Secondary	Force Platform	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.	5 weeks post-test
Secondary	Activity monitors outcome 1	The monitors measure Physical activity levels (inactive, light, moderate, vigorous) within 7 days	5 weeks post-test
Secondary	Activity monitors outcome 2	The monitors measure number of steps within 7 days	5 weeks post-test
Secondary	European Quality of Life 5-Dimension-3 Level	Self-perceived health related quality of life regarding	5 weeks post-test
Secondary	Multiple Sclerosis Walking Scale-12	Limitations in walking due to MS on 12 items with a scale 1-5, best score 12	5 weeks post-test
Secondary	Multiple Sclerosis Impact Scale-29	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)	5 weeks post-test
Secondary	Percentage of work	Self reported percentage of work	5 weeks post-test
Secondary	Trunk Impairment Scale Norwegian Version	Dynamic sitting balance, 6 items, top score 16.	10 weeks post-test
Secondary	Mini Balance Evaluation Systems 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	10 weeks post-test
Secondary	Force Platform	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.	10 weeks post-test
Secondary	Activity monitors outcome 1	The monitors measure Physical activity levels (inactive, light, moderate, vigorous) within 7 days	10 weeks post-test
Secondary	Activity monitors outcome 2	The monitors measure number of steps within 7 days	10 weeks post-test
Secondary	European Quality of Life 5-Dimension-3 Level	Self-perceived health related quality of life regarding	10 weeks post-test
Secondary	Multiple Sclerosis Walking Scale-12	Limitations in walking due to MS on 12 items with a scale 1-5, best score 12	10 weeks post-test
Secondary	Multiple Sclerosis Impact Scale-29	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)	10 weeks post-test
Secondary	Percentage of work	Self reported percentage of work	10 weeks post-test