- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Lincolnshire
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Lincoln, Lincolnshire, United Kingdom, LN6 7TS
- University of Lincoln
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Usual Care
People with a chronic lung condition who are physically inactive
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Minutes of self-reported moderate intensity equivalent physical activity per week
Time Frame: Baseline to 12 months
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Short Active Lives Survey
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Baseline to 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accelerometer measured physical activity: time (minutes per day) spent in moderate intensity activity
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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:
Time Frame: 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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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Arwel W Jones, PhD, University of Lincoln
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 190501
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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