Short Active Lives Survey in Chronic Lung Conditions

Lung Diseases Clinical Trial

Official title:

Short Active Lives Survey in Chronic Lung Conditions: an Exploratory Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04080583
• Other study ID #: 190501
• Status: Completed
• Start date: August 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2020
• Source: University of Lincoln
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 31, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Diseases

Locations

Country	Name	City	State
United Kingdom	University of Lincoln	Lincoln	Lincolnshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Lincoln

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Minutes of self-reported moderate intensity equivalent physical activity per week	Short Active Lives Survey	Baseline to 12 months
Secondary	Accelerometer measured physical activity: time (minutes per day) spent in moderate intensity activity	Actigraph wGT3X-BT	Baseline to 12 months
Secondary	Accelerometer measured physical activity: time (minutes per week) spent in light activity	Actigraph wGT3X-BT	Baseline to 12 months
Secondary	Accelerometer measured physical activity including: time (minutes per week) spent in vigorous activity	Actigraph wGT3X-BT	Baseline to 12 months
Secondary	Accelerometer measured physical activity: time (minutes per day) spent in sedentary state	Actigraph wGT3X-BT	Baseline to 12 months
Secondary	Accelerometer measured physical activity: average daily steps	Actigraph wGT3X-BT	Baseline to 12 months
Secondary	Accelerometer measured physical activity including: daily vector magnitude units	Actigraph wGT3X-BT	Baseline to 12 months
Secondary	EQ5D index	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).	Baseline to 12 months
Secondary	EQ VAS	Self-report of health status on a scale, 0 (worst health) - 100 (best health)	Baseline to 12 months
Secondary	Cost questionnaire	NHS resource use questionnaire	Baseline to 12 months
Secondary	Demographics:	Age, gender, ethnicity, comorbidities, social deprivation, MRC degree of breathlessness, oxygen use	Baseline to 12 months