Assessment of Activity Limitation in Asthma Patients

Completed

• Conditions: Asthma
• Interventions: Other: Assessment of activity capacities

• Registration Number: NCT01962142
• Lead Sponsor: Centre Hospitalier Universitaire Saint Pierre

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-10-15
• Study First Submitted QC: 2013-10-10
• Study First Posted: 2013-10-14
• Status Verified: 2015-08
• Primary Completion: 2017-12
• Study Completion: 2018-04
• Last Update Submitted: 2018-07-30
• Last Update Posted: 2018-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Exacerbated asthma patients	Assessment of activity capacities	-

Primary Outcome Measures

Name	Time	Method
Energy expenditure (expressed in MET's) measured during an ergospirometry, at the time of an exacerbation of asthma and 6 weeks later.	At the time of inclusion	One MET (Metabolic Equivalent of Task) is equal to an oxygen uptake about 3.5 ml O2/kg/min.

Secondary Outcome Measures

Name	Time	Method
Self-assessment of activity limitation	7 last days before inclusion
Walking distance in 6 min (expressed in meters) measured at the time of an exacerbation of asthma and 6 weeks later.	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.	At the time of inclusion

Trial Locations

Locations (1)

CHU St Pierre; pulmonology department; 🇧🇪 Brussels, Belgium