Physical Activity and Quality of Life in Fibrotic Lung Diseases After Initiating Anti-fibrotic Therapy and Pulmonary Rehabilitation
Evaluation of Physical Activity and Quality of Life in Fibrotic Lung Diseases After Initiating Anti-fibrotic Therapy and Pulmonary Rehabilitation
University of South Florida
70 participants
Sep 1, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria7
- Recently diagnosed (within 24 months) patients with PF-ILD, including IPF, as defined in the 'study population'
- Patients of 40 years and above and MMRC functional class II or higher
- Patients willing to provide consent and comply with study procedures
- Patient agrees to complete pulmonary rehabilitation program during the study period
- Patient must be antifibrotic naïve or on antifibrotic therapy for less than three months. To be included into the trial, the participant must be on a stable dose of immunosuppressants (for underlying disease causing ILD) and/or antifibrotic therapy for at least 30 days prior to enrollment.
- Subjects must be able to walk >150 meters in their screening 6MWT
- FVC ≥ 40% of predicted and DLco between 30% to 80% of predicted
Exclusion Criteria22
- PF-ILD including IPF patients who have already completed pulmonary rehabilitation within a year.
- Patients with acute exacerbation or active lung infection within 3 months prior to screening
- PF-ILD including IPF patients who are already receiving antifibrotic therapy for more than six months.
- Patients with significant pulmonary hypertension (PH)- defined as previous clinical or echocardiographic evidence of significant right heart failure, history of right heart catheterization showing cardiac index ≤ 2 l/min/m2 and PH requiring parenteral therapy with epoprostenol or Treprostinil.
- Metastatic malignancy under active treatment or active malignancy which would affect mobility
- Presence of concomitant severe or very severe chronic obstructive pulmonary disease (COPD) by ATS criteria.17 Mild to moderate cases will be included into the study.
- Presence of significant emphysema in CT scan of chest as determined by the study investigator
- PF-ILD patients who have limited mobility as a result of their underlying autoimmune disease
- Severe fatigue in sarcoidosis patients with fatigue associated sarcoidosis (FAS) score ≥ 35
- Patients requiring full-dose systemic anticoagulation, or with any other contraindication to nintedanib use
- Patients with active and symptomatic coronary artery disease
- Morbid obesity, defined as BMI>35
- Symptomatic moderate to severe valvular heart disease
- Known NYHA class-III heart disease or echocardiographic left ventricular ejection fraction ≤ 40%
- Inability to maintain oxygen saturation >88% with physical exertion despite supplemental oxygen
- Inability to ambulate for any reason
- Inability or unwilling to perform the required tests
- Presence of any other condition, that in the judgement of investigators may interfere with trial participation or may put the patient at risk when participating in the trial during the entire trial period.
- Women of childbearing potential will be advised to avoid becoming pregnant while receiving treatment with nintedanib and to use highly effective contraceptive methods at initiation of, during and at least 3 months after the last dose of nintedanib. Those patients who refuse to comply with abovementioned advice would be excluded from participating in the trial.
- Patient with moderate (Child Pugh B) or severe (Child Pugh C) hepatic impairment.
- Patients with signs and symptoms of acute myocardial ischemia.
- Patients with arterial thromboembolic events, known risk of bleeding and gastrointestinal perforation.
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Interventions
CP Insight Watch (Actigraph, Pensacola, FL) is usually worn on the wrist. The watch captures and records continuous high-resolution raw acceleration data to provide objective, real-world physical activity, mobility, and sleep measures, in near real time. That data is then processed by ActiLife software into what is called Epoch data (i.e. turning it into activity counts so that things such as moderate vigorous physical activity can be found). The device also passively scores every minute of recorded data as "Sleep" or "Wake" based on the amount of activity taking place.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05866198