Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

This is a 52-week prospective cohort study, involving IPF and PF-ILD patients. Those IPF and PF-ILD patients fulfilling inclusion criteria without meeting exclusion criteria will be considered for the study. An IPF diagnosis will be confirmed according to ATS/ERS/JRS/ALAT 2018 criteria. Other PF-ILD diagnoses will be confirmed using standard diagnostic criteria by PI. In case of diagnostic uncertainty, the study PI and sub-PI may be consulted for consensus. All subjects will be over the age of 40 years and of either sex. We will identify potential subjects from the ILD clinic at Tampa General Hospital. All consented subjects will have the following measurements recorded as part of their routine clinical assessment and standard of care: medical history, MMRC dyspnea scale, pulmonary function test (spirometry, lung volume and DLco), serum liver functions test, high resolution CT scan of chest and a 6MWT. The sarcoidosis-PF patients will fill out a FAS questionnaire, in addition. The study participants will complete the L-PF (L-PF symptoms and L-PF impacts), k-BILD, and FSS questionnaires. GAP index will be calculated. If indicated, echocardiogram and/or right heart catheterization will be performed. The 6MWT will be performed following guidelines for the Boehringer-Ingelheim 1199.187 IPF trial. The document is enclosed along with this submission. Following initial evaluation and baseline questionnaires, all participants will be provided an actigraphy watch (CP Insight Watch, Actigraph LLC, Pensacola, FL) which will be worn on the wrist for seven continuous days and participants will be encouraged to wear it for 24 hours a day. Actigraphy data will be monitored remotely via bluetooth and will be downloaded using the manufacturer's provided software. After completing seven days of baseline actigraphy assessment (this is the usual timeline to obtain prescription), treatment naïve subjects will begin nintedanib, 150 mg twice daily as per standard of care (SoC). Subjects already on nintedanib for less than three months and on stable dosing for at least a month, will continue their current regimen. All subjects will receive other treatments as per SoC, including immunosuppression and/or oxygen supplementation as needed. All participants will be enrolled in a standardized pulmonary rehabilitation program. Evaluations and follow-up will be scheduled at week 0, 12, 24, 36, and 52. The first 7 days after enrollment, during the baseline actigraphy assessment, will count as week 0. At each of these visits, participants will wear an actigraphy watch (CP Insight Watch, Actigraph LLC, Pensacola, FL) on the wrist for seven continuous days and participants will be encouraged to wear it for 24 hours a day. Actigraphy data will be monitored remotely via bluetooth and will be downloaded using the manufacturer's provided software. Thereafter, accelerometer reported PA indices will be measured for 7 continuous days at week 12, 24, 36, and 52. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05866198
Study type Interventional
Source University of South Florida
Contact Luis Diaz, MPH
Phone 813-396-2373
Email luisd2@usf.edu
Status Recruiting
Phase N/A
Start date September 1, 2023
Completion date May 2026

See also
  Status Clinical Trial Phase
Terminated NCT04119115 - Integrated Radiographic and Metabolomics Risk Assessment in Patients With Interstitial Lung Diseases
Active, not recruiting NCT04559581 - Post-marketing Surveillance of Ofev Capsules in Chronic Fibrosing Interstitial Lung Diseases With a Progressive Phenotype in Japan
Recruiting NCT05151640 - INCHANGE - Nintedanib for Changes in Cough and Dyspnea in Patients Suffering From Chronic Fibrosing Interstitial Lung Disease With a Progressive Phenotype in Everyday Clinical Practice: a Real-world Evaluation
Recruiting NCT02543073 - MSC for Treatment of Interstitial Lung Disease After Allo-HSCT Phase 1/Phase 2
Completed NCT02251964 - Rituximab in Interstitial Pneumonitis Phase 2/Phase 3
Terminated NCT01432080 - Steroids, Azithromycin, Montelukast, and Symbicort (SAMS) for Viral Respiratory Tract Infection Post Allotransplant Phase 2
Completed NCT01442779 - Clinical Trial of Low Dose Oral Interferon Alpha in Idiopathic Pulmonary Fibrosis Phase 2
Recruiting NCT05596760 - Promoting Goals-of-Care Discussions for Patients With Memory Problems and Their Caregivers N/A
Active, not recruiting NCT05321082 - A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs) Phase 3
Completed NCT04016168 - Idiopathic Pulmonary Fibrosis and Serum Bank
Recruiting NCT00258583 - Dorothy P. and Richard P. Simmons Center for ILD Research Registry
Recruiting NCT05855109 - Developing a Screening Tool for Interstitial Lung Disease in People With Rheumatoid Arthritis Using Risk Factors
Completed NCT05719233 - Assessment of Neuropsychiatric Function in Patients With Interstitial Lung Disease
Recruiting NCT04159129 - Effects of Pulmonary Rehabilitation on Walking Speed in Patients With COPD or ILD Patients
Completed NCT03313180 - A Trial to Evaluate the Safety of Long Term Treatment With Nintedanib in Patients With Scleroderma Related Lung Fibrosis Phase 3
Active, not recruiting NCT05065190 - A Study to Test How Well a Medicine Called Nintedanib Helps People in China With Progressive Lung Fibrosis Phase 3
Completed NCT03136120 - Cryobiopsy Study to Assess Drug Distribution in Subjects With Suspected Interstitial Lung Disease
Recruiting NCT04930666 - BREATHE ALD: A Shared Decision-Making Intervention for Adults With Advanced Lung Disease
Recruiting NCT05503030 - Correlation Between Changes in Lung Function and Changes in Cough and Dyspnoea in Nintedanib-treated Connective Tissue Disease Interstitial Lung Disease (CTD-ILD) Patients
Active, not recruiting NCT04702893 - INREAL - Nintedanib for Changes in Dyspnea and Cough in Patients Suffering From Chronic Fibrosing Interstitial Lung Disease (ILD) With a Progressive Phenotype in Everyday Clinical Practice: a Real-world Evaluation