Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2025-12-25 @ 11:12 PM
Study NCT ID:
NCT07202793
Status:
COMPLETED
Last Update Posted:
2025-10-02
First Post:
2025-08-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness and Tolerance of Respiratory Rehabilitation in Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Sponsor:
Poitiers University Hospital
Organization:
Study Overview
Official Title:
Effectiveness and Tolerance of Respiratory Rehabilitation in Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REHABTP
Brief Summary:
Observational study summary The goal of this observational study is to determine whether an outpatient pulmonary rehabilitation (PR) program-already known to be effective and safe for chronic obstructive pulmonary disease (COPD)-is equally effective and well-tolerated when COPD is complicated by pulmonary hypertension (PH).
Main question In adults with COPD + PH, does outpatient PR improve six-minute walk distance (6MWD) and remain safe, to the same extent as in adults with COPD without PH?
How the study is conducted
Researchers retrospectively analyse medical records from the University Hospital of Poitiers covering a ten-year period. Eligible participants are adults with COPD who completed at least three weeks of supervised PR and underwent echocardiography to assess PH probability. Two cohorts are compared:
COPD + PH (intermediate or high echocardiographic suspicion) COPD without PH (no echocardiographic suspicion) Key data collected Change in 6MWD between the start and end of PR (primary endpoint) Proportion of participants achieving a clinically meaningful improvement in 6MWD Occurrence of severe exacerbations (hospital- or emergency-treated events) during the year after PR All-cause mortality within one year Adverse events or program interruptions indicating PR tolerance
Main question In adults with COPD + PH, does outpatient PR improve six-minute walk distance (6MWD) and remain safe, to the same extent as in adults with COPD without PH?
How the study is conducted
Researchers retrospectively analyse medical records from the University Hospital of Poitiers covering a ten-year period. Eligible participants are adults with COPD who completed at least three weeks of supervised PR and underwent echocardiography to assess PH probability. Two cohorts are compared:
COPD + PH (intermediate or high echocardiographic suspicion) COPD without PH (no echocardiographic suspicion) Key data collected Change in 6MWD between the start and end of PR (primary endpoint) Proportion of participants achieving a clinically meaningful improvement in 6MWD Occurrence of severe exacerbations (hospital- or emergency-treated events) during the year after PR All-cause mortality within one year Adverse events or program interruptions indicating PR tolerance
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: