Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-25 @ 9:53 PM
Study NCT ID:
NCT03480451
Status:
TERMINATED
Last Update Posted:
2019-07-08
First Post:
2016-12-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Targeted Intervention for Patient Centered Outcome in Patients With Idiopathic Pulmonary Fibrosis
Sponsor:
Medical College of Wisconsin
Organization:
Study Overview
Official Title:
Targeted Intervention for Patient Centered Outcome in Patients With Idiopathic Pulmonary Fibrosis
Status:
TERMINATED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study considered futile
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IPF
Brief Summary:
Idiopathic pulmonary fibrosis (IPF), a chronic fibrotic lung disease of unknown cause, is characterized by relentless progression, with a three-year mortality of up to 50%. IPF has high morbidity, with 90% of patients reporting dyspnea at the time of diagnosis and this is strongly correlated with quality of life and mortality. As IPF progress, breathlessness worsens, physical functional capacity declines, and health-related quality of life deteriorates. Pulmonary rehabilitation (PR) can improve well-being in patients with other chronic lung disease, but little is known regarding PR in IPF.
Detailed Description:
The hypothesis is that the provision of a comprehensive pulmonary rehabilitation program to patients with IPF will significantly improve participant health related quality of life. The objective is to develop a comprehensive, multi-disciplinary 12-week PR program with disease specific educational components for IPF patients. The specific aims of the proposal is to evaluate the effect of the comprehensive PR program on 1) improvements in quality of life using the Medical Outcomes Study 36-Item Short Form 36 (SF-36), a quality of life instrument and 2) improvements in patient self-reported dyspnea scores using the chronic respiratory questionnaire. The investigator intends to evaluate sustained benefits of the PR intervention, changes in depression, anxiety, stress and functional physical capacity.
Study Oversight
Has Oversight DMC:
None
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?: