RECRUITING

Physical Activity and Quality of Life in Fibrotic Lung Diseases After Initiating Anti-fibrotic Therapy and Pulmonary Rehabilitation

Conditions

Lung Diseases, Interstitial Progressive phenotype anti-fibrotic therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Evaluation of Physical Activity and Quality of Life in Fibrotic Lung Diseases After Initiating Anti-fibrotic Therapy and Pulmonary Rehabilitation

Quick Facts

Study Start:2023-09-01

Study Completion:2026-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05866198

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Recently diagnosed (within 24 months) patients with PF-ILD, including IPF, as defined in the 'study population' 2. Patients of 40 years and above and MMRC functional class II or higher 3. Patients willing to provide consent and comply with study procedures 4. Patient agrees to complete pulmonary rehabilitation program during the study period 5. 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. 6. Subjects must be able to walk \>150 meters in their screening 6MWT 7. FVC ≥ 40% of predicted and DLco between 30% to 80% of predicted	1. PF-ILD including IPF patients who have already completed pulmonary rehabilitation within a year. 2. Patients with acute exacerbation or active lung infection within 3 months prior to screening 3. PF-ILD including IPF patients who are already receiving antifibrotic therapy for more than six months. 4. 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. 5. Metastatic malignancy under active treatment or active malignancy which would affect mobility 6. 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. 7. Presence of significant emphysema in CT scan of chest as determined by the study investigator 8. PF-ILD patients who have limited mobility as a result of their underlying autoimmune disease 9. Severe fatigue in sarcoidosis patients with fatigue associated sarcoidosis (FAS) score ≥ 35 10. Patients requiring full-dose systemic anticoagulation, or with any other contraindication to nintedanib use 11. Patients with active and symptomatic coronary artery disease 12. Morbid obesity, defined as BMI\>35 13. Symptomatic moderate to severe valvular heart disease 14. Known NYHA class-III heart disease or echocardiographic left ventricular ejection fraction ≤ 40% 15. Inability to maintain oxygen saturation \>88% with physical exertion despite supplemental oxygen 16. Inability to ambulate for any reason 17. Inability or unwilling to perform the required tests 18. 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. 19. 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. 20. Patient with moderate (Child Pugh B) or severe (Child Pugh C) hepatic impairment. 21. Patients with signs and symptoms of acute myocardial ischemia. 22. Patients with arterial thromboembolic events, known risk of bleeding and gastrointestinal perforation.

Inclusion Criteria

Exclusion Criteria

1. Recently diagnosed (within 24 months) patients with PF-ILD, including IPF, as defined in the 'study population'
2. Patients of 40 years and above and MMRC functional class II or higher
3. Patients willing to provide consent and comply with study procedures
4. Patient agrees to complete pulmonary rehabilitation program during the study period
5. 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.
6. Subjects must be able to walk \>150 meters in their screening 6MWT
7. FVC ≥ 40% of predicted and DLco between 30% to 80% of predicted

1. PF-ILD including IPF patients who have already completed pulmonary rehabilitation within a year.
2. Patients with acute exacerbation or active lung infection within 3 months prior to screening
3. PF-ILD including IPF patients who are already receiving antifibrotic therapy for more than six months.
4. 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.
5. Metastatic malignancy under active treatment or active malignancy which would affect mobility
6. 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.
7. Presence of significant emphysema in CT scan of chest as determined by the study investigator
8. PF-ILD patients who have limited mobility as a result of their underlying autoimmune disease
9. Severe fatigue in sarcoidosis patients with fatigue associated sarcoidosis (FAS) score ≥ 35
10. Patients requiring full-dose systemic anticoagulation, or with any other contraindication to nintedanib use
11. Patients with active and symptomatic coronary artery disease
12. Morbid obesity, defined as BMI\>35
13. Symptomatic moderate to severe valvular heart disease
14. Known NYHA class-III heart disease or echocardiographic left ventricular ejection fraction ≤ 40%
15. Inability to maintain oxygen saturation \>88% with physical exertion despite supplemental oxygen
16. Inability to ambulate for any reason
17. Inability or unwilling to perform the required tests
18. 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.
19. 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.
20. Patient with moderate (Child Pugh B) or severe (Child Pugh C) hepatic impairment.
21. Patients with signs and symptoms of acute myocardial ischemia.
22. Patients with arterial thromboembolic events, known risk of bleeding and gastrointestinal perforation.

Contacts and Locations

Study Contact

Luis Diaz, MPH

CONTACT

813-396-2373

luisd2@usf.edu

Elisabeth Ballans, BSN

CONTACT

813-844-7609

eballans@tgh.org

Study Locations (Sites)

University of South Florida/ Tampa General Hospital

Tampa, Florida, 33606

United States

Collaborators and Investigators

Sponsor: University of South Florida

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-01

Study Completion Date2026-05

Study Record Updates

Study Start Date2023-09-01

Study Completion Date2026-05

Terms related to this study

Keywords Provided by Researchers

Progressive phenotype
anti-fibrotic therapy

Additional Relevant MeSH Terms

Lung Diseases, Interstitial