- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04080583
Short Active Lives Survey in Chronic Lung Conditions
Short Active Lives Survey in Chronic Lung Conditions: an Exploratory Study
Short Actives Lives Survey is a common tool used to measure physical activity in the UK population. Self-reported measures such as the Short Active Lives Survey can be prone to bias. As such, during project evaluations, benefits may be exaggerated due to over-reporting of physical activity or downplayed due to underreporting of physical activity. There is also a lack of research reporting the typical short-term and long-term changes in physical activity (measured by the Short Active Lives Survey) in people with chronic lung conditions who are not receiving support to become active (i.e. usual care, control groups). Accelerometers are small lightweight activity monitors that can be worn on the waist. These monitors are known to provide accurate and reliable objective assessment of physical activity in people with lung conditions.
This research study will recruit a cohort of inactive people with lung conditions and determine changes in physical activity measured by both the Short Active Lives Survey and one of the most valid accelerometers used in people with lung conditions (Actigraph GT3X). The study will also evaluate how these physical activity measures relate to general health (health status and health care use) of people with lung conditions over 12 months. This study will provide information on the usefulness of using the Short Active Lives Survey in the future for measuring physical activity in people with lung conditions.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Lincolnshire
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Lincoln, Lincolnshire, Reino Unido, LN6 7TS
- University of Lincoln
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Diagnosis of Chronic Obstructive Pulmonary Disease, Bronchiectasis, Interstitial Lung Disease, Lung Cancer, Mesothelioma or Asthma
- Physically inactive defined as completing less than 30 minutes ore more of moderate intensity equivalent physical activity per week (measured by the Short Active Lives Survey)
Exclusion Criteria:
- Adults without a diagnosis of Chronic Obstructive Pulmonary Disease, Bronchiectasis, Interstitial Lung Disease, Lung Cancer, Mesothelioma or Asthma
- Age < 18 Years
- Completing 30 minutes or more of moderate intensity equivalent (MIE) physical activity per week
- Inability or unwillingness to sign informed consent
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Usual Care
People with a chronic lung condition who are physically inactive
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Minutes of self-reported moderate intensity equivalent physical activity per week
Periodo de tiempo: Baseline to 12 months
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Short Active Lives Survey
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Baseline to 12 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Accelerometer measured physical activity: time (minutes per day) spent in moderate intensity activity
Periodo de tiempo: Baseline to 12 months
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Actigraph wGT3X-BT
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Baseline to 12 months
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Accelerometer measured physical activity: time (minutes per week) spent in light activity
Periodo de tiempo: Baseline to 12 months
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Actigraph wGT3X-BT
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Baseline to 12 months
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Accelerometer measured physical activity including: time (minutes per week) spent in vigorous activity
Periodo de tiempo: Baseline to 12 months
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Actigraph wGT3X-BT
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Baseline to 12 months
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Accelerometer measured physical activity: time (minutes per day) spent in sedentary state
Periodo de tiempo: Baseline to 12 months
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Actigraph wGT3X-BT
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Baseline to 12 months
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Accelerometer measured physical activity: average daily steps
Periodo de tiempo: Baseline to 12 months
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Actigraph wGT3X-BT
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Baseline to 12 months
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Accelerometer measured physical activity including: daily vector magnitude units
Periodo de tiempo: Baseline to 12 months
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Actigraph wGT3X-BT
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Baseline to 12 months
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EQ5D index
Periodo de tiempo: Baseline to 12 months
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Based on self-rating of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression).
Each dimension is rated between 1 (no problems) to 5 (unable to/extreme problems).
Dimensions are combined to produce a five-digit number describing the individual's health status (ranging from 11111 to 55555).
Five digit number converted to an index based on the EQ-5D-5L value set for England.
Index ranges from -0.208 (worst possible health) to 1.000 (best possible health).
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Baseline to 12 months
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EQ VAS
Periodo de tiempo: Baseline to 12 months
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Self-report of health status on a scale, 0 (worst health) - 100 (best health)
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Baseline to 12 months
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Cost questionnaire
Periodo de tiempo: Baseline to 12 months
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NHS resource use questionnaire
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Baseline to 12 months
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Demographics:
Periodo de tiempo: Baseline to 12 months
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Age, gender, ethnicity, comorbidities, social deprivation, MRC degree of breathlessness, oxygen use
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Baseline to 12 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Arwel W Jones, PhD, University of Lincoln
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (Actual)
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
- 190501
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .