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

2021年9月15日 更新者：Nordlandssykehuset HF

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

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.

研究概览

地位

邀请报名

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (预期的)

30

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 挪威
      • Bodø、挪威
        • Physiotherapy department, Nordlandssykehuset HF
      • Bodø、挪威
        • Bodø Municipality

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 68年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
行为的：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.
有源比较器：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.
行为的：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
MS Work Difficulties Questionnaire-23
大体时间：Baseline
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
Six-Minutes Walk Test
大体时间：Baseline
Walking distance within six minutes
Baseline
MS Work Difficulties Questionnaire-23
大体时间：5 weeks 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).
5 weeks post-test
Six-Minutes Walk Test
大体时间：5 weeks post-test
Walking distance within six minutes
5 weeks post-test
MS Work Difficulties Questionnaire-23
大体时间：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).
10 week post-test
Six-Minutes Walk Test
大体时间：10 week post-test
Walking distance within six minutes
10 week post-test

次要结果测量

结果测量
措施说明
大体时间
Trunk Impairment Scale Norwegian Version
大体时间：Baseline
Dynamic sitting balance, 6 items, top score 16.
Baseline
Mini Balance Evaluation Systems Test
大体时间：Baseline
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
Force Platform
大体时间：Baseline
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
Activity monitors outcome 1
大体时间：Baseline
The monitors measure Physical activity levels (inactive, light, moderate, vigorous) within 7 days
Baseline
Activity monitors outcome 2
大体时间：Baseline
The monitors measure number of steps within 7 days
Baseline
European Quality of Life 5-Dimension-3 Level
大体时间：Baseline
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
Multiple Sclerosis Walking Scale-12
大体时间：Baseline
Limitations in walking due to MS on 12 items with a scale 1-5, best score 12
Baseline
Multiple Sclerosis Impact Scale-29
大体时间：baseline
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
Weight
大体时间：baseline
Self reported weight by kilogram
baseline
Height
大体时间：baseline
Self reported height by centimetre
baseline
age
大体时间：baseline
Self reported age by years
baseline
Social status
大体时间：baseline
Self reported social status; married, cohabitant, living alone
baseline
Type of multiple sclerosis
大体时间：baseline
Self reported main types: relapsing remitting, primary progressive, secondary progressive
baseline
Year of diagnosis multiple sclerosis
大体时间：baseline
Self reported by year
baseline
Medications
大体时间：baseline
Self reported by type of medications
baseline
Expanded disability status scale
大体时间：baseline
Self reported or from journal functional status at last yearly control by a neurologist
baseline
Occupation
大体时间：baseline
Self reported
baseline
Percentage of work
大体时间：baseline
Self reported percentage of work the previous month
baseline
Length of education
大体时间：baseline
Self reported choices: elementary school; high school; bachelor; masters degree; Doctor of philosophy degree
baseline
Trunk Impairment Scale Norwegian Version
大体时间：5 weeks post-test
Dynamic sitting balance, 6 items, top score 16.
5 weeks post-test
Mini Balance Evaluation Systems Test
大体时间：5 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
5 weeks post-test
Force Platform
大体时间：5 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.
5 weeks post-test
Activity monitors outcome 1
大体时间：5 weeks post-test
The monitors measure Physical activity levels (inactive, light, moderate, vigorous) within 7 days
5 weeks post-test
Activity monitors outcome 2
大体时间：5 weeks post-test
The monitors measure number of steps within 7 days
5 weeks post-test
European Quality of Life 5-Dimension-3 Level
大体时间：5 weeks post-test
Self-perceived health related quality of life regarding
5 weeks post-test
Multiple Sclerosis Walking Scale-12
大体时间：5 weeks post-test
Limitations in walking due to MS on 12 items with a scale 1-5, best score 12
5 weeks post-test
Multiple Sclerosis Impact Scale-29
大体时间：5 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)
5 weeks post-test
Percentage of work
大体时间：5 weeks post-test
Self reported percentage of work
5 weeks post-test
Trunk Impairment Scale Norwegian Version
大体时间：10 weeks post-test
Dynamic sitting balance, 6 items, top score 16.
10 weeks post-test
Mini Balance Evaluation Systems Test
大体时间：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
10 weeks post-test
Force Platform
大体时间：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.
10 weeks post-test
Activity monitors outcome 1
大体时间：10 weeks post-test
The monitors measure Physical activity levels (inactive, light, moderate, vigorous) within 7 days
10 weeks post-test
Activity monitors outcome 2
大体时间：10 weeks post-test
The monitors measure number of steps within 7 days
10 weeks post-test
European Quality of Life 5-Dimension-3 Level
大体时间：10 weeks post-test
Self-perceived health related quality of life regarding
10 weeks post-test
Multiple Sclerosis Walking Scale-12
大体时间：10 weeks post-test
Limitations in walking due to MS on 12 items with a scale 1-5, best score 12
10 weeks post-test
Multiple Sclerosis Impact Scale-29
大体时间：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)
10 weeks post-test
Percentage of work
大体时间：10 weeks post-test
Self reported percentage of work
10 weeks post-test

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Nordlandssykehuset HF

合作者

Hasselt University
Helse Nord
Nord University

调查人员

  • 研究主任：Petter Oien, PhD、Nordlandssykehuset HF

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年8月27日

初级完成 (预期的)

2021年12月31日

研究完成 (预期的)

2022年8月30日

研究注册日期

首次提交

2021年8月27日

首先提交符合 QC 标准的

2021年9月15日

首次发布 (实际的)

2021年9月27日

研究记录更新

最后更新发布 (实际的)

2021年9月27日

上次提交的符合 QC 标准的更新

2021年9月15日

最后验证

2021年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CoreDISTparticipation

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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