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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04172155
Other study ID # ESMOI (29BRC19.0225)
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 17, 2019
Est. completion date September 29, 2020

Study information

Verified date January 2021
Source University Hospital, Brest
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

the aim of this study is to evaluate the evolution of self-esteem during a pulmonary rehabilitation program, in COPD patients.


Recruitment information / eligibility

Status Completed
Enrollment 76
Est. completion date September 29, 2020
Est. primary completion date September 29, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France CHRU de Brest Brest
France CH Pays de Morlaix Morlaix

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other MMRC The modified medical research Council dyspnea scale measure dyspnea MMRC is measured at the biginning and at the end of the pulmonary rehabilitation program (4 weeks)
Primary PSI-6 the physical self inventory- 6 (PSI-6) allows to evaluate self esteem PSI-6 is measured at the biginning and at the end of the pulmonary rehabilitation program (4 weeks)
Secondary 6MWT The 6-minute walk test allows to evaluate exercise capacity the 6MWT is measured at the biginning and at the end of the pulmonary rehabilitation program (4 weeks)
Secondary HAD the hospital anxiety and depressive scale (HAD) measure the anxiety and depression HAD is measured at the biginning and at the end of the pulmonary rehabilitation program (4 weeks)
Secondary SGRQ the Saint-George respiratory Questionnaire (SGRQ) measure the quality of life SGRQ is measured at the biginning and at the end of the pulmonary rehabilitation program (4 weeks)
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