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Completed

NCT Number: NCT01962142

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).

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU St Pierre; pulmonology department

Brussels, 1000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Assessment of activity capacities

Other

Primary outcomes

  1. 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

  1. Walking distance in 6 min (expressed in meters) measured at the time of an exacerbation of asthma and 6 weeks later.

    Time frame: 6 weeks

  2. Quality of life (assessed with the Asthma Quality of Life Questionnaire) measured at the time of an exacerbation of asthma and 6 weeks later.

    Time frame: At the time of inclusion

  3. Self-assessment of activity limitation

    Time frame: 7 last days before inclusion

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Saint Pierre

Other

Registry information

Official study title

Subjective and Objective Assessment of Activity Limitation in Asthma Patients

Important dates

Study start
2012
Primary completion
2017
Study completion
2018
First posted
Oct 14, 2013
Registry last updated
Jul 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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