Lung DiseasesNCT04080583
Short Active Lives Survey in Chronic Lung Conditions
An observational study of Lung Diseases, run by University of Lincoln at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Lung Diseases
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2019to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The eligibility criteria has been designed to be as broad as possible so that findings can be generalisable to the wider population of inactive people with lung conditions. The main study population will be recruited via convenience sampling at the participant identification centres within Lincolnshire Community Health Services, South Lincolnshire CCG, South West Lincolnshire CCG, Lincolnshire East CCG, Lincolnshire West CCG and United Lincolnshire Hospitals NHS Trust.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Lincoln
Lincoln, Lincolnshire, LN6 7TS
About this study
Official title: 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.
- Conditions
- Lung Diseases
- Keywords
- Physical activity, Health Status
- Medical subject headings
- Lung Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | People with a chronic lung condition who are physically inactive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minutes of self-reported moderate intensity equivalent physical activity per week
Short Active Lives Survey
Measured: Baseline to 12 months
Secondary outcomes (10)
Accelerometer measured physical activity: time (minutes per day) spent in moderate intensity activity
Actigraph wGT3X-BT
Measured: Baseline to 12 months
Accelerometer measured physical activity: time (minutes per week) spent in light activity
Actigraph wGT3X-BT
Measured: Baseline to 12 months
Accelerometer measured physical activity including: time (minutes per week) spent in vigorous activity
Actigraph wGT3X-BT
Measured: Baseline to 12 months
Accelerometer measured physical activity: time (minutes per day) spent in sedentary state
Actigraph wGT3X-BT
Measured: Baseline to 12 months
Accelerometer measured physical activity: average daily steps
Actigraph wGT3X-BT
Measured: Baseline to 12 months
Accelerometer measured physical activity including: daily vector magnitude units
Actigraph wGT3X-BT
Measured: Baseline to 12 months
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).
Measured: Baseline to 12 months
EQ VAS
Self-report of health status on a scale, 0 (worst health) - 100 (best health)
Measured: Baseline to 12 months
Cost questionnaire
NHS resource use questionnaire
Measured: Baseline to 12 months
Demographics:
Age, gender, ethnicity, comorbidities, social deprivation, MRC degree of breathlessness, oxygen use
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start1 Aug 2019
- Primary completion30 Nov 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lincoln
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arwel W Jones, PhD, Principal investigator, University of Lincoln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04080583
- Sponsor's protocol ID
- 190501
- Status last verified
- Jan 2020
- First submitted
- 3 Sep 2019
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Active Lives Survey in Chronic Lung Conditions: an Exploratory Study
- ClinicalTrials.gov ID
- NCT04080583
- Acronym / sponsor ID
- 190501
- Conditions
- Lung Diseases
- Keywords
- Physical activity, Health Status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of LincolnUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 6 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Usual Care | – | –People with a chronic lung condition who are physically inactive |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The eligibility criteria has been designed to be as broad as possible so that findings can be generalisable to the wider population of inactive people with lung conditions. The main study population will be recruited via convenience sampling at the participant identification centres within Lincolnshire Community Health Services, South Lincolnshire CCG, South West Lincolnshire CCG, Lincolnshire East CCG, Lincolnshire West CCG and United Lincolnshire Hospitals NHS Trust.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Minutes of self-reported moderate intensity equivalent physical activity per week
Time frame: Baseline to 12 months
Short Active Lives Survey
10 secondary outcomes
Accelerometer measured physical activity: time (minutes per day) spent in moderate intensity activity
Time frame: Baseline to 12 months
Accelerometer measured physical activity: time (minutes per week) spent in light activity
Time frame: Baseline to 12 months
Accelerometer measured physical activity including: time (minutes per week) spent in vigorous activity
Time frame: Baseline to 12 months
Accelerometer measured physical activity: time (minutes per day) spent in sedentary state
Time frame: Baseline to 12 months
Accelerometer measured physical activity: average daily steps
Time frame: Baseline to 12 months
Accelerometer measured physical activity including: daily vector magnitude units
Time frame: Baseline to 12 months
EQ5D index
Time frame: Baseline to 12 months
EQ VAS
Time frame: Baseline to 12 months
Cost questionnaire
Time frame: Baseline to 12 months
Demographics:
Time frame: Baseline to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arwel W Jones, PhD principal investigator
University of Lincoln
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Diseases, run by University of Lincoln at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minutes of self-reported moderate intensity equivalent physical activity per week (time frame: Baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2021.