Clinical trial NCT03157817: Sedentary Behaviour, Physical Activity and Cardiometabolic Risk in Chronic Obstructive Pulmonary Disease
Official title: Sedentary Behaviour, Physical Activity and Cardiometabolic Risk in Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Lead sponsor: Loughborough University
Sponsor class: OTHER
First posted: 2017-05-17
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. People with COPD or healthy volunteers without any respiratory conditions
2. Over age of 40
3. Body Mass Index below 35

Exclusion Criteria:

1. Age below 40
2. BMI above 35
3. Unable to complete assessment visit

Primary outcomes:
measure: cardiometabolic risk
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: Respiratory Biomedical Research Centre
state: Leicestershire
city: Loughborough
country: United Kingdom
facility: Loughborough Universtiy
state: Leicestershire
Study officials:
References: