Assessment of Activity Limitation in Asthma Patients

Asthma Clinical Trial

Official title:

Subjective and Objective Assessment of Activity Limitation in Asthma Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01962142
• Other study ID #: B076201214059
• Status: Completed
• Start date: September 2012
• Est. completion date: April 2018

Study information

• Verified date: August 2015
• Source: Centre Hospitalier Universitaire Saint Pierre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• Assessment of activity capacities

Locations

Country	Name	City	State
Belgium	CHU St Pierre; pulmonology department	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Saint Pierre

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Energy expenditure (expressed in MET's) measured during an ergospirometry, at the time of an exacerbation of asthma and 6 weeks later.	One MET (Metabolic Equivalent of Task) is equal to an oxygen uptake about 3.5 ml O2/kg/min.	At the time of inclusion
Secondary	Walking distance in 6 min (expressed in meters) measured at the time of an exacerbation of asthma and 6 weeks later.		6 weeks
Secondary	Quality of life (assessed with the Asthma Quality of Life Questionnaire) measured at the time of an exacerbation of asthma and 6 weeks later.		At the time of inclusion
Secondary	Self-assessment of activity limitation		7 last days before inclusion