Functions, Physical Activity and Employment for Individuals With MS: A Pilot Feasibility Study (CoreDISTp)
Innovative Follow-up Across Health Care Levels to Optimize Functions, Physical Activity and Employment for Individuals With MS: A Pilot Feasibility Study
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Ожидаемый)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Bodø, Норвегия
- Physiotherapy department, Nordlandssykehuset HF
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Bodø, Норвегия
- Bodø Municipality
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: 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. |
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.
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Активный компаратор: 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.
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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.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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MS Work Difficulties Questionnaire-23
Временное ограничение: Baseline
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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).
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Baseline
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Six-Minutes Walk Test
Временное ограничение: Baseline
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Walking distance within six minutes
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Baseline
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MS Work Difficulties Questionnaire-23
Временное ограничение: 5 weeks post-test
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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).
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5 weeks post-test
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Six-Minutes Walk Test
Временное ограничение: 5 weeks post-test
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Walking distance within six minutes
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5 weeks post-test
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MS Work Difficulties Questionnaire-23
Временное ограничение: 10 week post-test
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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).
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10 week post-test
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Six-Minutes Walk Test
Временное ограничение: 10 week post-test
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Walking distance within six minutes
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10 week post-test
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Trunk Impairment Scale Norwegian Version
Временное ограничение: Baseline
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Dynamic sitting balance, 6 items, top score 16.
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Baseline
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Mini Balance Evaluation Systems Test
Временное ограничение: 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
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Baseline
|
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Force Platform
Временное ограничение: Baseline
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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.
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Baseline
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Activity monitors outcome 1
Временное ограничение: Baseline
|
The monitors measure Physical activity levels (inactive, light, moderate, vigorous) within 7 days
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Baseline
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Activity monitors outcome 2
Временное ограничение: Baseline
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The monitors measure number of steps within 7 days
|
Baseline
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European Quality of Life 5-Dimension-3 Level
Временное ограничение: 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.
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Baseline
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Multiple Sclerosis Walking Scale-12
Временное ограничение: Baseline
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Limitations in walking due to MS on 12 items with a scale 1-5, best score 12
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Baseline
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Multiple Sclerosis Impact Scale-29
Временное ограничение: baseline
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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)
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baseline
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Weight
Временное ограничение: baseline
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Self reported weight by kilogram
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baseline
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Height
Временное ограничение: baseline
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Self reported height by centimetre
|
baseline
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age
Временное ограничение: baseline
|
Self reported age by years
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baseline
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Social status
Временное ограничение: baseline
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Self reported social status; married, cohabitant, living alone
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baseline
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Type of multiple sclerosis
Временное ограничение: baseline
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Self reported main types: relapsing remitting, primary progressive, secondary progressive
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baseline
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Year of diagnosis multiple sclerosis
Временное ограничение: baseline
|
Self reported by year
|
baseline
|
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Medications
Временное ограничение: baseline
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Self reported by type of medications
|
baseline
|
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Expanded disability status scale
Временное ограничение: baseline
|
Self reported or from journal functional status at last yearly control by a neurologist
|
baseline
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Occupation
Временное ограничение: baseline
|
Self reported
|
baseline
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Percentage of work
Временное ограничение: baseline
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Self reported percentage of work the previous month
|
baseline
|
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Length of education
Временное ограничение: baseline
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Self reported choices: elementary school; high school; bachelor; masters degree; Doctor of philosophy degree
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baseline
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Trunk Impairment Scale Norwegian Version
Временное ограничение: 5 weeks post-test
|
Dynamic sitting balance, 6 items, top score 16.
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5 weeks post-test
|
|
Mini Balance Evaluation Systems Test
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 5 weeks post-test
|
Self-perceived health related quality of life regarding
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5 weeks post-test
|
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Multiple Sclerosis Walking Scale-12
Временное ограничение: 5 weeks post-test
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Limitations in walking due to MS on 12 items with a scale 1-5, best score 12
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5 weeks post-test
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Multiple Sclerosis Impact Scale-29
Временное ограничение: 5 weeks post-test
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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)
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5 weeks post-test
|
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Percentage of work
Временное ограничение: 5 weeks post-test
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Self reported percentage of work
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5 weeks post-test
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Trunk Impairment Scale Norwegian Version
Временное ограничение: 10 weeks post-test
|
Dynamic sitting balance, 6 items, top score 16.
|
10 weeks post-test
|
|
Mini Balance Evaluation Systems Test
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 10 weeks post-test
|
Self-perceived health related quality of life regarding
|
10 weeks post-test
|
|
Multiple Sclerosis Walking Scale-12
Временное ограничение: 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
Временное ограничение: 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
|
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Percentage of work
Временное ограничение: 10 weeks post-test
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Self reported percentage of work
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10 weeks post-test
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Соавторы и исследователи
Спонсор
Следователи
- Директор по исследованиям: Petter Oien, PhD, Nordlandssykehuset HF
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Ожидаемый)
Завершение исследования (Ожидаемый)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- CoreDISTparticipation
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
Клинические исследования CoreDISTparticipation
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Nordlandssykehuset HFUniversity Hospital of North Norway; The Royal Norwegian Ministry of Health; Norwegian... и другие соавторыЕще не набирают