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- Ensayo clínico NCT01993095
FlexToBa for People With Multiple Sclerosis
Improving Functional Performance in Persons With MS Via Physical Activity DVD Intervention
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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-
Illinois
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Urbana, Illinois, Estados Unidos, 61801
- University of Illinois at Urbana-Champaign
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- being non-active, defined as reporting not engaging in regular activity (30 minutes accumulated per day) on more than two days of the week in the prior six months;
- aged 50 years and older;
- fluent in English;
- relapse-free in the last 30 days;
- ambulatory with minimal assistance(i.e., walk independently or with a single-point assistive walking device such as a cane);
- the provision of medical clearance for participation in a physical activity program by participants' physicians, along with a physician-confirmed diagnosis of MS (communication with physicians will be facilitated by research staff).
Exclusion Criteria:
- self-reported physical activity on a regular basis within the last six months (2 times or more per week);
- younger than 50 years of age;
- relapse in the last 30 days;
- no regular access to a television;
- no physician-confirmed diagnosis of multiple sclerosis;
- unable to successfully score above 21 (out of 39)on the Telephone Interview of Cognitive Status questionnaire (TICS-M).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Experimental: FlexToBa physical activity DVD
Participants in this arm will receive a physical activity program delivered by DVD that focuses on exercises targeting flexibility, toning and balance.
These exercises will be progressive in nature throughout the six months and will also focus on modifications for all ability levels.
Participants will be provided with three DVDs including: an Introduction to physical activity, Sessions 1-3, and Sessions 4-6, which they will be asked to watch and participate in over the course of six months.
|
Subjects will be participating in a home-based physical activity program that focuses on flexibility, toning and balance.
Exercises will be progressive over the six-months and will highlight modifications for varying levels.
This program will be delivered on 3 DVDs.
Participants will be asked to exercise with the DVD at least three times per week.
|
Comparador activo: Usual care-Wait list
Participants in this arm will receive a DVD that focuses on healthy aging topics but does not include physical activity.
They will receive the FlexToBa DVD after the completion of the 6-month follow-up testing.
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Participants in this arm will receive a DVD that focuses on healthy aging topics but does not include physical activity.
They will receive the FlexToBa DVD after the completion of the 6-month follow-up testing.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change from baseline to six-months in assessments of functional fitness of sedentary adults who have Multiple Sclerosis
Periodo de tiempo: Baseline and six months
|
The measurements will include: Short physical performance battery -- measures walking speed, ability to rise from a chair, and standing balance |
Baseline and six months
|
Change from baseline to six-months in assessments of functional fitness of sedentary adults who have MS
Periodo de tiempo: Baseline and six-months
|
Measurements will include: Timed 20-foot walk test -- walk 25 feet as quickly as possible; |
Baseline and six-months
|
Change in assessments of functional fitness assessments in sedentary adults with MS
Periodo de tiempo: Baseline and six-months
|
Measurements will include: 6-minute walk test -- walk as much as possible (in terms of distance) for 6 minutes; |
Baseline and six-months
|
Change from baseline to six-months in assessments of functional fitness of sedentary adults with MS
Periodo de tiempo: Baseline and six-months
|
Measurements will include: Grip strength -- using a dynamometer, participants will demonstrate isometric grip strength; |
Baseline and six-months
|
Change from baseline to six-months in assessments of functional fitness of sedentary adults who have MS
Periodo de tiempo: Baseline and six-months
|
Measurements will include: Flexibility -- sit and reach (lower body flexibility) and back scratch test (upper body flexibility) |
Baseline and six-months
|
Change from baseline to six-months in assessments of functional fitness of sedentary adults with MS
Periodo de tiempo: Baseline and six-months
|
Measurements will include: Upper body strength -- bicep curls consisting of lifting a light hand-weight as many times as possible in 30-seconds; |
Baseline and six-months
|
Change from baseline to six-months in assessments of functional fitness of sedentary adults who have MS
Periodo de tiempo: Baseline and six-months
|
Measurements will include: Balance -- a timed (up to 30-seconds) unassisted one-leg stand test with eyes open on each leg. |
Baseline and six-months
|
Change from baseline to six-months in assessments of reported quality of life in people with MS
Periodo de tiempo: Baseline and six months
|
The Leeds Multiple Sclerosis Quality of Life Scale will be used as a disease specific quality of life measure for people with MS.
|
Baseline and six months
|
Change from baseline to six-months in assessments of reported quality of life in people with MS
Periodo de tiempo: Baseline and six-months
|
The Satisfaction with Life Scale will be used to assess global life satisfaction and is sensitive enough to detect changes in participants' perceptions over the course of a clinical intervention.
|
Baseline and six-months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change from baseline to six-months in assessments of cognitive performance in sedentary adults with MS
Periodo de tiempo: Baseline and six months
|
The Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery, which will be administered to assess cognitive performance.
|
Baseline and six months
|
Change from baseline to six-months in assessments of reported barriers self-efficacy in people with MS
Periodo de tiempo: Baseline and six months
|
Participants' situation-specific self-confidence for physical activity will be assessed using The Barriers Self-Efficacy Scale, which taps subjects' perceived capabilities to exercise three times per week for 40 minutes over the next two months in the face of commonly identified barriers to participation.
|
Baseline and six months
|
Changes in physical activity relating to specified exercise program in sedentary adults with MS
Periodo de tiempo: Baseline and six months
|
Adherence to exercise program as documented by daily exercise logs.
|
Baseline and six months
|
Objective changes in physical activity in sedentary adults with MS
Periodo de tiempo: Baseline and six months
|
Objective assessment of physical activity via accelerometry over seven days time.
|
Baseline and six months
|
Self-reported changes in physical activity in sedentary adults with MS
Periodo de tiempo: Baseline and six months
|
Subjective assessment of physical activity via the Godin Leisure Time Exercise Questionnaire, which assesses frequency of involvement in strenuous, moderate and light activities.
|
Baseline and six months
|
Change from baseline to six-months in assessments of reported gait self-efficacy in sedentary adults with MS
Periodo de tiempo: Baseline and six-months
|
Participants' situation-specific self-confidence for physical activity will be assessed using The Gait Self-Efficacy Scale, which will assess participants' beliefs in their capabilities to negotiate stairs and objects in their path.
|
Baseline and six-months
|
Change from baseline to six-months in assessments of reported exercise self-efficacy in sedentary people with MS
Periodo de tiempo: Baseline and six-months
|
The Exercise Self-Efficacy Scale will assess participants' beliefs in their ability to continue exercising on a three time per week basis at moderate intensities for 40+ minutes per session in the future.
|
Baseline and six-months
|
Change from baseline to six-months in assessments of reported self-efficacy of walking in sedentary people with MS
Periodo de tiempo: Baseline and six-months
|
Walking Self-Efficacy Scale for Duration will assess participants' beliefs in their physical capability to successfully complete incremental 5-minute intervals (up to 40 minutes)of walking at a moderately fast pace.
|
Baseline and six-months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Edward McAuley, PhD, University of Illinois at Urbana-Champaign
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IL-0009
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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