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

NCT05866198 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2023-12-15

No results posted yet for this study

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.

Conditions

  • Lung Diseases, Interstitial

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.

Sponsors & Collaborators

  • University of South Florida

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2025-05-31
Completion
2026-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05866198 on ClinicalTrials.gov