- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01962142
Assessment of Activity Limitation in Asthma Patients
Subjective and Objective Assessment of Activity Limitation in Asthma Patients
Limitation of activity is one of the main item used by composites scores designed to assess the level of asthma control. Since this item is systematically subjectively assessed by the patient, the investigators would like to know if these subjective data are correlated with objective data.
Aims of this study are: 1) To describe what means "limitation of activity" for asthma patients and how they deal with; 2) To describe the objective exercise capacity and characteristics of daily activity in two situations (on exacerbation, out of an exacerbation).
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
-
-
-
Brussels, Belgien, 1000
- CHU St Pierre; pulmonology department
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Diagnosis of asthma made by a pulmonologist.
- Age ≥ 18 yrs-old, < 65 yrs-old.
- Moderate or severe exacerbation of asthma (as defined by Reddel et al in 2009) at the time of inclusion.
Exclusion Criteria:
- All other diseases than asthma that can affect the physical activity (e.g. orthopaedic or neuromuscular disease, cardiac or vascular disease).
- Pregnancy or suspicion of pregnancy at the time of inclusion. The women who become pregnant during the study period will be excluded.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Exacerbated asthma patients
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Energy expenditure (expressed in MET's) measured during an ergospirometry, at the time of an exacerbation of asthma and 6 weeks later.
Tidsramme: At the time of inclusion
|
One MET (Metabolic Equivalent of Task) is equal to an oxygen uptake about 3.5 ml O2/kg/min.
|
At the time of inclusion
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Walking distance in 6 min (expressed in meters) measured at the time of an exacerbation of asthma and 6 weeks later.
Tidsramme: 6 weeks
|
6 weeks
|
|
Quality of life (assessed with the Asthma Quality of Life Questionnaire) measured at the time of an exacerbation of asthma and 6 weeks later.
Tidsramme: At the time of inclusion
|
At the time of inclusion
|
|
Self-assessment of activity limitation
Tidsramme: 7 last days before inclusion
|
7 last days before inclusion
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- B076201214059
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