- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Lincolnshire
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Lincoln, Lincolnshire, Vereinigtes Königreich, LN6 7TS
- University of Lincoln
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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Usual Care
People with a chronic lung condition who are physically inactive
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Minutes of self-reported moderate intensity equivalent physical activity per week
Zeitfenster: Baseline to 12 months
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Short Active Lives Survey
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Baseline to 12 months
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Accelerometer measured physical activity: time (minutes per day) spent in moderate intensity activity
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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:
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Arwel W Jones, PhD, University of Lincoln
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 190501
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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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