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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• 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

Locations
United States
Florida
University of South Florida/ Tampa General Hospital
RECRUITING
Tampa
Contact Information
Primary
Luis Diaz, MPH
luisd2@usf.edu
813-396-2373
Backup
Elisabeth Ballans, BSN
eballans@tgh.org
813-844-7609
Time Frame
Start Date: 2023-09-01
Estimated Completion Date: 2026-05
Participants
Target number of participants: 70
Sponsors
Leads: University of South Florida

This content was sourced from clinicaltrials.gov