- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03157817
Sedentary Behaviour, Physical Activity and Cardiometabolic Risk in Chronic Obstructive Pulmonary Disease (SPAaRC)
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
Leicestershire
-
Leicester, Leicestershire, Storbritannien, LE3 9QP
- Respiratory Biomedical Research Centre
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Loughborough, Leicestershire, Storbritannien, LE11 3TU
- Loughborough Universtiy
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
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.
Beskrivning
Inclusion Criteria:
- People with COPD or healthy volunteers without any respiratory conditions
- Over age of 40
- Body Mass Index below 35
Exclusion Criteria:
- Age below 40
- BMI above 35
- Unable to complete assessment visit
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Case-Control
- Tidsperspektiv: Tvärsnitt
Kohorter och interventioner
Grupp / Kohort |
|---|
|
Chronic Obstructive Pulmonary Disease
Patients with a diagnosis of Chronic Obstructive Pulmonary Disease
|
|
Healthy Volunteers
Volunteers without any respiratory condition or symptoms
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
cardiometabolic risk
Tidsram: baseline
|
aggregated measure based on lipid levels, fasting glucose, glycated haemoglobin (A1c) (HbA1c), homeostatic model assessment (HOMA) and blood pressure
|
baseline
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- SPAaRCLUprotocol1.2
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Läkemedels- och apparatinformation, studiedokument
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