NCT03092700

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 28, 2017

Completed
8 days until next milestone

Study Start

First participant enrolled

April 5, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2017

Completed
Last Updated

February 24, 2021

Status Verified

February 1, 2021

Enrollment Period

4 months

First QC Date

March 18, 2017

Last Update Submit

February 23, 2021

Conditions

COPDDyspneaRehabilitation; Tobacco UseEmotional Disturbances

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Correlation between physical improvement, quality of life improvement and time to recognize facial emotions.

    6 weeks

  • Correlations between physical improvement and production of the smile.

    6 weeks

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

COPD patients admitted for a pulmonary rehabilitation

You may qualify if:

  • COPD patients with pulmonary rehabilitation indication, hospitalized in Department of Pulmonary Diseases in La Pitié-Salpêtrière, Paris, France.
  • Age of 40 at least.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre d'Investigation Clinique Paris Est, Groupe Hospitalier Pitié-Salpêtrière

Paris, 75013, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveDyspneaTobacco UseAffective Symptoms

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsBehaviorBehavioral Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2017

First Posted

March 28, 2017

Study Start

April 5, 2017

Primary Completion

August 16, 2017

Study Completion

August 16, 2017

Last Updated

February 24, 2021

Record last verified: 2021-02

Locations

FR(1)