COPDESMOINCT04172155
Pulmonary Rehabilitation and Self-esteem in Patients With COPD
An observational study of COPD, run by University Hospital, Brest at 2 sites in France.
Trial summary
the aim of this study is to evaluate the evolution of self-esteem during a pulmonary rehabilitation program, in COPD patients. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- COPD
- How many people
- 76 participants
- Where
- 2 sitesFrance
- Study dates
- 17 Dec 2019to 29 Sep 2020
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COPD patients admitted to a pulmonary rehabilitation program
Who may be able to join
- Patient with stage 2 to 4 (A to D) COPD admitted to a pulmonary rehabilitation program
- Patient aged 18 or over
- Patient able to consent and having signed a consent form
Who cannot join
- Patient with pain, osteoarthritis or shoulder surgery
- Patient with a history of Pneumonectomy, lobectomy less than 6 months old
- Refusal of participation
- Patient with an inability to complete a pulmonary rehabilitation program in totality
- Pregnant or breast-feeding women
- Patient under tutorship or curatorship
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Effects of Pulmonary Rehabilitation on Self-esteem in Patients With COPD
the aim of this study is to evaluate the evolution of self-esteem during a pulmonary rehabilitation program, in COPD patients.
- Conditions
- COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
PSI-6
the physical self inventory- 6 (PSI-6) allows to evaluate self esteem
Measured: PSI-6 is measured at the biginning and at the end of the pulmonary rehabilitation program (4 weeks)
Secondary outcomes (3)
6MWT
The 6-minute walk test allows to evaluate exercise capacity
Measured: the 6MWT is measured at the biginning and at the end of the pulmonary rehabilitation program (4 weeks)
HAD
the hospital anxiety and depressive scale (HAD) measure the anxiety and depression
Measured: HAD is measured at the biginning and at the end of the pulmonary rehabilitation program (4 weeks)
SGRQ
the Saint-George respiratory Questionnaire (SGRQ) measure the quality of life
Measured: SGRQ is measured at the biginning and at the end of the pulmonary rehabilitation program (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start17 Dec 2019
- Primary completion29 Sep 2020
- Study completion29 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04172155
- Sponsor's protocol ID
- ESMOI (29BRC19.0225)
- Acronym
- ESMOI
- Status last verified
- Jan 2021
- First submitted
- 13 Nov 2019
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Publications
Fox, K.R. et Corbin, C.B.The Physical Self-Perception Profile : Devlopment and Preliminary Validation. Journal of Sport and Exercise Psychology, 11(4), p. 408 430, 1989
Ninot G, Moullec G, Desplan J, Prefaut C, Varray A. Daily functioning of dyspnea, self-esteem and physical self in patients with moderate COPD before, during and after a first inpatient rehabilitation program. Disabil Rehabil. 2007 Nov 30;29(22):1671-8. doi: 10.1080/09638280601055949.
PubMed 17852227
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pulmonary Rehabilitation on Self-esteem in Patients With COPD
- ClinicalTrials.gov ID
- NCT04172155
- Acronym / sponsor ID
- ESMOI / ESMOI (29BRC19.0225)
- Conditions
- COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 17 Dec 2019 (actual)
- Primary completion
- 29 Sep 2020 (actual)
- Study completion
- 29 Sep 2020 (actual)
- First posted
- 21 Nov 2019 (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.
the aim of this study is to evaluate the evolution of self-esteem during a pulmonary rehabilitation program, in COPD patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients admitted to a pulmonary rehabilitation program
Key inclusion criteria (3 listed)
- Patient with stage 2 to 4 (A to D) COPD admitted to a pulmonary rehabilitation program
- Patient aged 18 or over
- Patient able to consent and having signed a consent form
Key exclusion criteria (6 listed)
- Patient with pain, osteoarthritis or shoulder surgery
- Patient with a history of Pneumonectomy, lobectomy less than 6 months old
- Refusal of participation
- Patient with an inability to complete a pulmonary rehabilitation program in totality
- Pregnant or breast-feeding women
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
PSI-6
Time frame: PSI-6 is measured at the biginning and at the end of the pulmonary rehabilitation program (4 weeks)
the physical self inventory- 6 (PSI-6) allows to evaluate self esteem
3 secondary outcomes
6MWT
Time frame: the 6MWT is measured at the biginning and at the end of the pulmonary rehabilitation program (4 weeks)
HAD
Time frame: HAD is measured at the biginning and at the end of the pulmonary rehabilitation program (4 weeks)
SGRQ
Time frame: SGRQ is measured at the biginning and at the end of the pulmonary rehabilitation program (4 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 27 Jan 2021.
- BackgroundFox, K.R. et Corbin, C.B.The Physical Self-Perception Profile : Devlopment and Preliminary Validation. Journal of Sport and Exercise Psychology, 11(4), p. 408 430, 1989
- Background: PubMed 17852227Ninot G, Moullec G, Desplan J, Prefaut C, Varray A. Daily functioning of dyspnea, self-esteem and physical self in patients with moderate COPD before, during and after a first inpatient rehabilitation program. Disabil Rehabil. 2007 Nov 30;29(22):1671-8. doi: 10.1080/09638280601055949.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by University Hospital, Brest at 2 sites 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 3 inclusion and 6 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 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
PSI-6 (time frame: PSI-6 is measured at the biginning and at the end of the pulmonary rehabilitation program (4 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04172155, which also lists 2 linked publications.
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 27 Jan 2021.