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RECRUITING
NCT05866198
NA

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

Sponsor: University of South Florida

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2023-09-01

Completion Date

2026-05

Last Updated

2023-12-15

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Actigraph CP Insight Watch

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)

University of South Florida/ Tampa General Hospital

Tampa, Florida, United States