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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03092700
Other study ID # 2017-A00045-48
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 5, 2017
Est. completion date August 16, 2017

Study information

Verified date February 2021
Source Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To evaluate whether pulmonary rehabilitation improves emotional cognition, using facial emotions recognition and smile production, by improving the emotional dimension of dyspnoea in patients with chronic obstructive pulmonary disease (COPD).To evaluate whether pulmonary rehabilitation improves emotional cognition, using facial emotions recognition and smile production, by improving the emotional dimension of dyspnoea in patients with chronic obstructive pulmonary disease (COPD).


Description:

The aim of the study will be to evaluate the effect of pulmonary rehabilitation on dyspnoea emotional component and on emotional cognition. It will add a better understanding of the mechanisms of pulmonary rehabilitation on dyspnoea. Patients with COPD will be included before starting a pulmonary rehabilitation and be evaluated with questionnaires (including the Multidimensional Dyspnea Profile, and quality of life questionnaires), emotional cognition (at rest and right after an endurance test, using some short movies sequences and pictures of faces expressing some well defined emotions) and smile production analysis. After having followed a pulmonary rehabilitation, the same evaluation will be realised and results will be compared before and after the intervention.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date August 16, 2017
Est. primary completion date August 16, 2017
Accepts healthy volunteers No
Gender All
Age group 40 Years to 90 Years
Eligibility Inclusion Criteria: - COPD patients with pulmonary rehabilitation indication, hospitalized in Department of Pulmonary Diseases in La Pitié-Salpêtrière, Paris, France. - Age of 40 at least. Exclusion Criteria: - Facial paralysis - Neuromuscular disease - Contraindication for pulmonary rehabilitation - Severe depression syndrom or psychiatric disease - Drug use - Impaired vision - Higher functions disorders (Mini Mental Score Examination < 26) - Severe obesity (BMI>40kg/m²)

Study Design


Locations

Country Name City State
France Centre d'Investigation Clinique Paris Est, Groupe Hospitalier Pitié-Salpêtrière Paris

Sponsors (1)

Lead Sponsor Collaborator
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary emotional cognition Emotional cognition in patients with chronic dyspnoea using time to recognize some emotions on short movies and pictures of facial emotions. 6 weeks
Secondary Correlation between physical improvement, quality of life improvement and time to recognize facial emotions. Correlations 6 weeks
Secondary Correlations between physical improvement and production of the smile. Correlations 6 weeks
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