Actively Recruiting
Physical Activity and Quality of Life in Fibrotic Lung Diseases After Initiating Anti-fibrotic Therapy and Pulmonary Rehabilitation
Led by University of South Florida · Updated on 2023-12-15
70
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The planned study is a prospective cohort interventional study in IPF and PF-ILD patients after initiating anti-fibrotic therapy and pulmonary rehabilitation. The study aims to investigate if accelerometer measured PA parameters, such as total daily steps, moderate-vigorous PA demonstrate significant and sustained changes longitudinally from baseline in this cohort and can predict disease progression. The study also explores if the actigraphic PA indices correlate with patients' quality of life, change in six-minute walk distance (6MWD), GAP score, fatigue score, change in patients' dyspnea score/scale, radiographic extent of the disease, and pulmonary function test parameters. The study is exploratory in nature. It will provide vital information for clinical as well as research purposes. Clinically, accelerometer measured PA can be utilized for therapeutic target and prognostication, helping to develop patient centric care. The measured indices can also be useful to serve as meaningful endpoints to plan larger and definitive studies in IPF and PF-ILD patients.
CONDITIONS
Official Title
Physical Activity and Quality of Life in Fibrotic Lung Diseases After Initiating Anti-fibrotic Therapy and Pulmonary Rehabilitation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Recently diagnosed patients with progressive fibrotic interstitial lung disease, including idiopathic pulmonary fibrosis, within 24 months
- Age 40 years or older and MMRC functional class II or higher
- Willing to provide consent and comply with study procedures
- Agree to complete a pulmonary rehabilitation program during the study
- Anti-fibrotic therapy naive or on anti-fibrotic treatment for less than three months with stable immunosuppressant or anti-fibrotic dosing for at least 30 days
- Able to walk more than 150 meters in a six-minute walk test
- Forced vital capacity (FVC) of 40% or more and diffusing capacity (DLco) between 30% and 80% of predicted values
You will not qualify if you...
- Completed pulmonary rehabilitation within the past year
- Acute lung infection or exacerbation within 3 months before screening
- On anti-fibrotic therapy for more than six months
- Significant pulmonary hypertension or right heart failure
- Active metastatic or mobility-affecting malignancy
- Severe chronic obstructive pulmonary disease or significant emphysema
- Limited mobility from autoimmune disease
- Severe fatigue in sarcoidosis patients (FAS score 35 or higher)
- Need for full-dose systemic anticoagulation or contraindication to nintedanib
- Active symptomatic coronary artery disease
- Morbid obesity (BMI over 35)
- Moderate to severe valvular heart disease
- NYHA class III heart disease or left ventricular ejection fraction 40% or less
- Cannot maintain oxygen saturation over 88% during exertion despite oxygen
- Unable to walk or perform required tests
- Any condition that may interfere with participation or increase risk
- Women of childbearing potential not agreeing to use effective contraception during and 3 months after treatment
- Moderate or severe liver impairment (Child Pugh B or C)
- Signs of acute myocardial ischemia
- History of arterial thromboembolic events, bleeding risk, or gastrointestinal perforation
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of South Florida/ Tampa General Hospital
Tampa, Florida, United States, 33606
Actively Recruiting
Research Team
L
Luis Diaz, MPH
CONTACT
E
Elisabeth Ballans, BSN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
0
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