COPDSPAaRCNCT03157817
Sedentary Behaviour, Physical Activity and Cardiometabolic Risk in Chronic Obstructive Pulmonary Disease
An observational study of COPD, run by Loughborough University at 2 sites in United Kingdom.
Trial summary
Investigation into the associations between sedentary behaviour, physical activity, body composition and cardiometabolic risk in COPD. A single assessment visit with fasting blood tests, body composition and strength measures followed by a week of activity monitor wear to record sitting time and physical activity. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- COPD
- How many people
- 90 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 18 Oct 2016to 15 Aug 2017
- How long will I take part?
- 1 Week
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Those with COPD recruited from both secondary care and an existing primary care database. Healthy volunteers recruited from an existing database recruited through community advertisement.
Who may be able to join
- People with COPD or healthy volunteers without any respiratory conditions
- Over age of 40
- Body Mass Index below 35
Who cannot join
- Age below 40
- BMI above 35
- Unable to complete assessment visit
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Respiratory Biomedical Research Centre
Leicester, Leicestershire, LE3 9QP
Loughborough Universtiy
Loughborough, Leicestershire, LE11 3TU
About this study
Investigation into the associations between sedentary behaviour, physical activity, body composition and cardiometabolic risk in COPD. A single assessment visit with fasting blood tests, body composition and strength measures followed by a week of activity monitor wear to record sitting time and physical activity. Cardiometabolic risk markers include fasting glucose, HBA1c, HOMA and lipids and blood pressure.
Read the detailed description
Chronic Obstructive Pulmonary Disease (COPD) is a condition associated with low levels of physical activity and sedentary behaviour (i.e. too much sitting). In addition there is a higher level of heart disease and diabetes in those with COPD. This adds to the burden of the disease. This study will be measuring sitting time using a specific waist-worn monitoring device. The amount of sitting time will then be compared with cardiovascular (heart disease) risk markers, diabetes risk markers and body composition (i.e. fat and muscle mass).
The measurement of cardiovascular and diabetes risk markers will include blood tests to look at blood sugar levels, lipids, cholesterol and insulin resistance as well as blood pressure and heart rate measurement. Body composition measurements will include height, weight, waist circumference, hip circumference as well as scales that will measure body fat and muscle mass and a scan called a dual energy x-ray absorptiometer (DEXA) which uses a type of x-ray to measure body tissues. This involves a very low dose of radiation, much smaller than a normal x-ray.
Quadriceps strength will be measured to provide information on the strength of the muscles.
The sitting device will be worn for 1 week and at the end of this week it will be delivered or sent back by the participant together with a questionnaire about how acceptable the device is to wear.
Additional measures will be included in the assessment in order to examine the results appropriately and reduce bias. These measurements include lung function (breathing) tests, fitness tests (4 metre gait speed and incremental shuttle walk test) and questionnaires about age, gender, ethnicity, medical diagnoses, medications (with detail about oral steroid use), smoking (including pack yrs), exacerbation history, breathlessness, anxiety, depression and motivation, frailty, Physical Activity and Sedentary Behaviour Questionnaire, Employment and Occupational status and history, device Acceptability questionnaire.
Participants will attend an assessment visit. As some of the blood tests need to be done under fasting conditions, i.e. without consuming food or liquids other than water for 8 hours, this will normally take place in the morning. Following the blood tests they will be offered a drink and snack before undertaking any physical measures.
Healthy volunteers of a similar age will also be recruited and attend the same assessment visit to allow comparison between groups to be made.
- Conditions
- COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
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 |
|---|---|---|
| Chronic Obstructive Pulmonary Disease | Patients with a diagnosis of Chronic Obstructive Pulmonary Disease | |
| Healthy Volunteers | Volunteers without any respiratory condition or symptoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiometabolic risk
aggregated measure based on lipid levels, fasting glucose, glycated haemoglobin (A1c) (HbA1c), homeostatic model assessment (HOMA) and blood pressure
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start18 Oct 2016
- Primary completion15 Aug 2017
- Study completion15 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Loughborough University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruth Trethewey, Loughborough University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03157817
- Sponsor's protocol ID
- SPAaRCLUprotocol1.2
- Acronym
- SPAaRC
- Status last verified
- Aug 2017
- First submitted
- 15 May 2017
- Last updated
- 1 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Available on request from Ruth Trethewey
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sedentary Behaviour, Physical Activity and Cardiometabolic Risk in Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT03157817
- Acronym / sponsor ID
- SPAaRC / SPAaRCLUprotocol1.2
- Conditions
- COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Loughborough UniversityUniversity, hospital or other
- Study start
- 18 Oct 2016 (actual)
- Primary completion
- 15 Aug 2017 (actual)
- Study completion
- 15 Aug 2017 (actual)
- First posted
- 17 May 2017 (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.
Investigation into the associations between sedentary behaviour, physical activity, body composition and cardiometabolic risk in COPD. A single assessment visit with fasting blood tests, body composition and strength measures followed by a week of activity monitor wear to record sitting time and physical activity. Cardiometabolic risk markers include fasting glucose, HBA1c, HOMA and lipids and blood pressure.
Detailed description
Chronic Obstructive Pulmonary Disease (COPD) is a condition associated with low levels of physical activity and sedentary behaviour (i.e. too much sitting). In addition there is a higher level of heart disease and diabetes in those with COPD. This adds to the burden of the disease. This study will be measuring sitting time using a specific waist-worn monitoring device. The amount of sitting time will then be compared with cardiovascular (heart disease) risk markers, diabetes risk markers and body composition (i.e. fat and muscle mass).
The measurement of cardiovascular and diabetes risk markers will include blood tests to look at blood sugar levels, lipids, cholesterol and insulin resistance as well as blood pressure and heart rate measurement. Body composition measurements will include height, weight, waist circumference, hip circumference as well as scales that will measure body fat and muscle mass and a scan called a dual energy x-ray absorptiometer (DEXA) which uses a type of x-ray to measure body tissues. This involves a very low dose of radiation, much smaller than a normal x-ray.
Quadriceps strength will be measured to provide information on the strength of the muscles.
The sitting device will be worn for 1 week and at the end of this week it will be delivered or sent back by the participant together with a questionnaire about how acceptable the device is to wear.
Additional measures will be included in the assessment in order to examine the results appropriately and reduce bias. These measurements include lung function (breathing) tests, fitness tests (4 metre gait speed and incremental shuttle walk test) and questionnaires about age, gender, ethnicity, medical diagnoses, medications (with detail about oral steroid use), smoking (including pack yrs), exacerbation history, breathlessness, anxiety, depression and motivation, frailty, Physical Activity and Sedentary Behaviour Questionnaire, Employment and Occupational status and history, device Acceptability questionnaire.
Participants will attend an assessment visit. As some of the blood tests need to be done under fasting conditions, i.e. without consuming food or liquids other than water for 8 hours, this will normally take place in the morning. Following the blood tests they will be offered a drink and snack before undertaking any physical measures.
Healthy volunteers of a similar age will also be recruited and attend the same assessment visit to allow comparison between groups to be made.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Week
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Obstructive Pulmonary Disease | – | –Patients with a diagnosis of Chronic Obstructive Pulmonary Disease |
| Healthy Volunteers | – | –Volunteers without any respiratory condition or symptoms |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Those with COPD recruited from both secondary care and an existing primary care database. Healthy volunteers recruited from an existing database recruited through community advertisement.
Key inclusion criteria (3 listed)
- People with COPD or healthy volunteers without any respiratory conditions
- Over age of 40
- Body Mass Index below 35
Key exclusion criteria (3 listed)
- Age below 40
- BMI above 35
- Unable to complete assessment visit
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
cardiometabolic risk
Time frame: baseline
aggregated measure based on lipid levels, fasting glucose, glycated haemoglobin (A1c) (HbA1c), homeostatic model assessment (HOMA) and blood pressure
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 1 Sep 2017.
- Individual participant dataSharing planned: No. Available on request from Ruth Trethewey
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by Loughborough University at 2 sites 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 3 inclusion and 3 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 1 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
cardiometabolic risk (time frame: baseline). 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 1 Sep 2017.