COPDREAD-COG BPCONCT03092700
Pulmonary Rehabilitation, Dyspnoea and Emotional Cognition in COPD
An observational study of COPD and Dyspnea, run by Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- COPD, Dyspnea, Rehabilitation; Tobacco Use
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 5 Apr 2017to 16 Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COPD patients admitted for a pulmonary rehabilitation
Who may be able to join
- COPD patients with pulmonary rehabilitation indication, hospitalized in Department of Pulmonary Diseases in La Pitié-Salpêtrière, Paris, France.
- Age of 40 at least.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
France1 site
Centre d'Investigation Clinique Paris Est, Groupe Hospitalier Pitié-Salpêtrière
Paris, 75013
About this study
Official title: Effects of Pulmonary Rehabilitation on Dyspnoea Affective Dimension and Emotional Cognition in Patients With Chronic Obstructive Pulmonary Disease
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).
Read the detailed 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.
- Conditions
- COPD, Dyspnea, Rehabilitation; Tobacco Use, Emotional Disturbances
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea, Tobacco Use, Affective Symptoms
What is being measured
The primary outcome is the main question the study is designed to answer.
emotional cognition
Emotional cognition in patients with chronic dyspnoea using time to recognize some emotions on short movies and pictures of facial emotions.
Measured: 6 weeks
Secondary outcomes (2)
Correlation between physical improvement, quality of life improvement and time to recognize facial emotions.
Correlations
Measured: 6 weeks
Correlations between physical improvement and production of the smile.
Correlations
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2017
- Study start5 Apr 2017
- Primary completion16 Aug 2017
- Study completion16 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03092700
- Sponsor's protocol ID
- 2017-A00045-48
- Acronym
- READ-COG BPCO
- Status last verified
- Feb 2021
- First submitted
- 18 Mar 2017
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pulmonary Rehabilitation on Dyspnoea Affective Dimension and Emotional Cognition in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT03092700
- Acronym / sponsor ID
- READ-COG BPCO / 2017-A00045-48
- Conditions
- COPD, Dyspnea, Rehabilitation; Tobacco Use, Emotional Disturbances
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le SommeilUniversity, hospital or other
- Study start
- 5 Apr 2017 (actual)
- Primary completion
- 16 Aug 2017 (actual)
- Study completion
- 16 Aug 2017 (actual)
- First posted
- 28 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients admitted for a pulmonary rehabilitation
Key inclusion criteria (2 listed)
- COPD patients with pulmonary rehabilitation indication, hospitalized in Department of Pulmonary Diseases in La Pitié-Salpêtrière, Paris, France.
- Age of 40 at least.
Key exclusion criteria (8 listed)
- Facial paralysis
- Neuromuscular disease
- Contraindication for pulmonary rehabilitation
- Severe depression syndrom or psychiatric disease
- Drug use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
emotional cognition
Time frame: 6 weeks
Emotional cognition in patients with chronic dyspnoea using time to recognize some emotions on short movies and pictures of facial emotions.
2 secondary outcomes
Correlation between physical improvement, quality of life improvement and time to recognize facial emotions.
Time frame: 6 weeks
Correlations between physical improvement and production of the smile.
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and Dyspnea, run by Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
emotional cognition (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.