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).

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Other: Assessment of activity capacities

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1000
    • CHU St Pierre; pulmonology department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Exacerbated asthma patients coming to the outpatient clinic of pulmonology.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Exacerbated asthma patients	Other: Assessment of activity capacities

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Self-assessment of activity limitation	7 last days before inclusion

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Saint Pierre

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: October 15, 2012
• First Submitted That Met QC Criteria: October 10, 2013
• First Posted (Estimate): October 14, 2013

Study Record Updates

• Last Update Posted (Actual): July 31, 2018
• Last Update Submitted That Met QC Criteria: July 30, 2018
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: B076201214059