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Clinical Trials/NCT01962142
NCT01962142CompletedNot Applicable

Subjective and Objective Assessment of Activity Limitation in Asthma Patients

Centre Hospitalier Universitaire Saint Pierre1 site in 1 country20 target enrollmentStarted: September 2012Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
20
Locations
1
Primary Endpoint
Energy expenditure (expressed in MET's) measured during an ergospirometry, at the time of an exacerbation of asthma and 6 weeks later.

Study Overview

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).

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Energy expenditure (expressed in MET's) measured during an ergospirometry, at the time of an exacerbation of asthma and 6 weeks later.

Time Frame: 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 Outcomes

  • 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)

Investigators

Sponsor
Centre Hospitalier Universitaire Saint Pierre
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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