- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03157817
Sedentary Behaviour, Physical Activity and Cardiometabolic Risk in Chronic Obstructive Pulmonary Disease (SPAaRC)
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Leicestershire
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Leicester, Leicestershire, Storbritannia, LE3 9QP
- Respiratory Biomedical Research Centre
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Loughborough, Leicestershire, Storbritannia, LE11 3TU
- Loughborough Universtiy
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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.
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Case-Control
- Tidsperspektiver: Tverrsnitt
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
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Chronic Obstructive Pulmonary Disease
Patients with a diagnosis of Chronic Obstructive Pulmonary Disease
|
|
Healthy Volunteers
Volunteers without any respiratory condition or symptoms
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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cardiometabolic risk
Tidsramme: baseline
|
aggregated measure based on lipid levels, fasting glucose, glycated haemoglobin (A1c) (HbA1c), homeostatic model assessment (HOMA) and blood pressure
|
baseline
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SPAaRCLUprotocol1.2
Plan for individuelle deltakerdata (IPD)
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IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
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