Clinical trial NCT03480451: Targeted Intervention for Patient Centered Outcome in Patients With Idiopathic Pulmonary Fibrosis
Official title: Targeted Intervention for Patient Centered Outcome in Patients With Idiopathic Pulmonary Fibrosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2018-03-29
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of IPF confirmed by lung biopsy or by characteristic pattern on high resolution computed tomogram (HRCT)
* No identifiable cause of lung fibrosis
* PR not received in the past year
* Ability to walk

Exclusion Criteria:

* History of unstable angina
* Deterioration cardiac or neurological disease
* Pregnancy or lactation
* Degenerative arthritis or other limitation to mobility
* PR in the past 12 months

Primary outcomes:
measure: Assess the change in coping skills for patients with IPF before and after a comprehensive pulmonary rehabilitation program.
timeFrame: 12 months
measure: Assess the change in quality of life for patients with IPF before and after a comprehensive pulmonary rehabilitation program.
timeFrame: 12 months
measure: Assess the change in depression, anxiety for patients with IPF before and after a comprehensive pulmonary rehabilitation program.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Froedtert Memorial Lutheran Hospital
state: Wisconsin
Study officials:
affiliation: Medical College of WI
name: Vijay Ramalingam, MD
role: PRINCIPAL_INVESTIGATOR
References:
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