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Active, Not Recruiting

NCT Number: NCT06110468

Physical Function, Health and Employment for People With Multiple Sclerosis

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–67 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nordlandssykehuset HF

Bodø, Nordland, 8092, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CoreDISTParticipation

Other

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.

Primary outcomes

  1. Multiple Sclerosis Work Difficulties Questionnaire -23 Norwegian version

    Time frame: 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).

  2. Levels of physical activity measured using ActiGraph wGT3x-BT monitors

    Time frame: 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 outcomes

  1. 6 meter walk test

    Time frame: Baseline, 9, 16 and 52 weeks post baseline

    Walking distance (meters) within six minutes

  2. Step count using ActiGraph wGT3x-BT monitors

    Time frame: 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

  3. Fatigue Severity Scale -Norwegian version

    Time frame: 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).

  4. Multiple Sclerosis Walking Scale-12

    Time frame: 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.

  5. Mini Balance Evaluation Systems Test (MiniBESTest)

    Time frame: 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.

  6. Trunk Impairment Scale-modified Norwegian version (TISmodNV)

    Time frame: 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.

  7. Postural control measured by AccuGait Optimized force platforms

    Time frame: Baseline, 9, 16 and 52 weeks post baseline

    Measures postural control in standing, tandem, one-leg standing: postural sway of center of pressure.

  8. European Quality of Life 5-Dimension (EQ-5D-5L) + Complementary questions

    Time frame: 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.

  9. Multiple Sclerosis Impact Scale 29-Norwegian version

    Time frame: 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.

  10. Patient Global Impression of Change - physical activity and balance

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Nordlandssykehuset HF

Other

Collaborators

  • Helgeland Hospital Trust
  • Nord University
  • Norwegian Labour and Welfare Administration
  • The Royal Norwegian Ministry of Health
  • UiT The Arctic University of Norway
  • University Hospital of North Norway
  • University of Tasmania

Registry information

Official study title

Tailored Follow-up for Persons With Multiple Sclerosis to Optimize Physical Functions, Health and Employment: a Prospective Single-blinded Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2035
First posted
Oct 31, 2023
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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