Nordlandssykehuset HF
Bodø, Nordland, 8092, Norway
NCT Number: NCT06110468
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.
This study is active but is not currently recruiting participants.
18 year–67 year
All sexes
Interventional
Not applicable
Bodø, Nordland, 8092, Norway
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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).
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
Time frame: Baseline, 9, 16 and 52 weeks post baseline
Walking distance (meters) within six minutes
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
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).
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.
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.
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.
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.
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.
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.
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.
Nordlandssykehuset HF
Other
Tailored Follow-up for Persons With Multiple Sclerosis to Optimize Physical Functions, Health and Employment: a Prospective Single-blinded Randomized Controlled Trial
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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