- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Lincolnshire
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Lincoln, Lincolnshire, Royaume-Uni, LN6 7TS
- University of Lincoln
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Usual Care
People with a chronic lung condition who are physically inactive
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Minutes of self-reported moderate intensity equivalent physical activity per week
Délai: Baseline to 12 months
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Short Active Lives Survey
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Baseline to 12 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Accelerometer measured physical activity: time (minutes per day) spent in moderate intensity activity
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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:
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Arwel W Jones, PhD, University of Lincoln
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 190501
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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