Pulmonary Rehabilitation and Self-esteem in Patients With COPD (ESMOI)

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.

Study Overview

• Status: Completed
• Conditions: COPD

• Study Type: Observational
• Enrollment (Actual): 76

Contacts and Locations

Study Locations

• France
  • Brest, France, 29609
    • CHRU de Brest
  • Morlaix, France, 29672
    • CH Pays de Morlaix

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

COPD patients admitted to a pulmonary rehabilitation program

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2019
• Primary Completion (Actual): September 29, 2020
• Study Completion (Actual): September 29, 2020

Study Registration Dates

• First Submitted: November 13, 2019
• First Submitted That Met QC Criteria: November 20, 2019
• First Posted (Actual): November 21, 2019

Study Record Updates

• Last Update Posted (Actual): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: ESMOI (29BRC19.0225)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available beginning one year and ending five years following the publication
• IPD Sharing Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No