Pulmonary Rehabilitation and Self-esteem in Patients With COPD

NCT04172155 | Completed

• 1 other identifier: ESMOI (29BRC19.0225)
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 6MWT

  the 6MWT is measured at the biginning and at the end of the pulmonary rehabilitation program (4 weeks)

• HAD

  HAD is measured at the biginning and at the end of the pulmonary rehabilitation program (4 weeks)

• SGRQ

  SGRQ is measured at the biginning and at the end of the pulmonary rehabilitation program (4 weeks)

Other Outcomes (1)

• MMRC

  MMRC is measured at the biginning and at the end of the pulmonary rehabilitation program (4 weeks)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

COPD patients admitted to a pulmonary rehabilitation program

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (2)

CHRU de Brest

Brest, 29609, France

Location

CH Pays de Morlaix

Morlaix, 29672, France

Location

Related 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

  BACKGROUND

• 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.

  PMID: 17852227 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2019
• First Posted: November 21, 2019
• Study Start: December 17, 2019
• Primary Completion: September 29, 2020
• Study Completion: September 29, 2020
• Last Updated: January 27, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning one year and ending five years following the publication
• 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.

Locations

FR (2)