Short Active Lives Survey in Chronic Lung Conditions

• Sponsor: University of Lincoln (Other)
• Overall Status: Completed
• CT.gov ID: NCT04080583
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Actual Duration (Months): 17
• Patients Per Site Per Month: 4.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Lung Diseases

Study Design

• Study Type: Observational
• Actual Enrollment: 80 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Short Active Lives Survey in Chronic Lung Conditions: an Exploratory Study
• Actual Study Start Date: Aug 1, 2019
• Actual Primary Completion Date: Nov 30, 2020
• Actual Study Completion Date: Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Usual Care People with a chronic lung condition who are physically inactive

Outcome Measures

Primary Outcome Measures

1. Minutes of self-reported moderate intensity equivalent physical activity per week [Baseline to 12 months]

   Short Active Lives Survey

Secondary Outcome Measures

1. Accelerometer measured physical activity: time (minutes per day) spent in moderate intensity activity [Baseline to 12 months]

   Actigraph wGT3X-BT

2. Accelerometer measured physical activity: time (minutes per week) spent in light activity [Baseline to 12 months]

   Actigraph wGT3X-BT

3. Accelerometer measured physical activity including: time (minutes per week) spent in vigorous activity [Baseline to 12 months]

   Actigraph wGT3X-BT

4. Accelerometer measured physical activity: time (minutes per day) spent in sedentary state [Baseline to 12 months]

   Actigraph wGT3X-BT

5. Accelerometer measured physical activity: average daily steps [Baseline to 12 months]

   Actigraph wGT3X-BT

6. Accelerometer measured physical activity including: daily vector magnitude units [Baseline to 12 months]

   Actigraph wGT3X-BT

7. EQ5D index [Baseline to 12 months]

   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).

8. EQ VAS [Baseline to 12 months]

   Self-report of health status on a scale, 0 (worst health) - 100 (best health)

9. Cost questionnaire [Baseline to 12 months]

   NHS resource use questionnaire

10. Demographics: [Baseline to 12 months]

    Age, gender, ethnicity, comorbidities, social deprivation, MRC degree of breathlessness, oxygen use

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Lincoln	Lincoln	Lincolnshire	United Kingdom	LN6 7TS

Sponsors and Collaborators

• University of Lincoln

Investigators

• Principal Investigator: Arwel W Jones, PhD, University of Lincoln

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Lincoln
• ClinicalTrials.gov Identifier: NCT04080583
• Other Study ID Numbers: 190501
• First Posted: Sep 6, 2019
• Last Update Posted: Apr 27, 2021
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Lincoln: Physical activity; Health Status
• Additional relevant MeSH terms: Lung Diseases

Study Results

No Results Posted as of Apr 27, 2021