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

NCT05866198 | Recruiting DMC

• 1 other identifier: STUDY003811
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Progressive phenotype; anti-fibrotic therapy

Outcome Measures

Primary Outcomes (1)

• change in six-minute walk distance from baseline to 52 weeks

  The 6-minute walk test (6MWT) is an assessment that a doctor may use to determine a person's exercise tolerance. It is a low risk test that measures how far a person can walk in 6 minutes.

  baseline to 52 weeks

Secondary Outcomes (1)

• Change in Accelerometer Measurements

  From baseline to Day 7.

Interventions

Actigraph CP Insight Watch DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• PF-ILD including IPF patients who have already completed pulmonary rehabilitation within a year.
• Patients with acute exacerbation or active lung infection within 3 months prior to screening
• PF-ILD including IPF patients who are already receiving antifibrotic therapy for more than six months.
• 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.
• Metastatic malignancy under active treatment or active malignancy which would affect mobility
• 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.
• Presence of significant emphysema in CT scan of chest as determined by the study investigator
• PF-ILD patients who have limited mobility as a result of their underlying autoimmune disease
• Severe fatigue in sarcoidosis patients with fatigue associated sarcoidosis (FAS) score ≥ 35
• Patients requiring full-dose systemic anticoagulation, or with any other contraindication to nintedanib use
• Patients with active and symptomatic coronary artery disease
• Morbid obesity, defined as BMI\>35
• Symptomatic moderate to severe valvular heart disease
• Known NYHA class-III heart disease or echocardiographic left ventricular ejection fraction ≤ 40%
• Inability to maintain oxygen saturation \>88% with physical exertion despite supplemental oxygen

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

University of South Florida/ Tampa General Hospital

Tampa, Florida, 33606, United States

RECRUITING

Related Publications (4)

• Raghu G, Collard HR, Anstrom KJ, Flaherty KR, Fleming TR, King TE Jr, Martinez FJ, Brown KK. Idiopathic pulmonary fibrosis: clinically meaningful primary endpoints in phase 3 clinical trials. Am J Respir Crit Care Med. 2012 May 15;185(10):1044-8. doi: 10.1164/rccm.201201-0006PP. Epub 2012 Apr 13.

  PMID: 22505745 BACKGROUND

• Sgalla G, Biffi A, Richeldi L. Idiopathic pulmonary fibrosis: Diagnosis, epidemiology and natural history. Respirology. 2016 Apr;21(3):427-37. doi: 10.1111/resp.12683. Epub 2015 Nov 23.

  PMID: 26595062 BACKGROUND

• Root ED, Graney B, Baird S, Churney T, Fier K, Korn M, McCormic M, Sprunger D, Vierzba T, Wamboldt FS, Swigris JJ. Physical activity and activity space in patients with pulmonary fibrosis not prescribed supplemental oxygen. BMC Pulm Med. 2017 Nov 23;17(1):154. doi: 10.1186/s12890-017-0495-2.

  PMID: 29169394 BACKGROUND

• Bahmer T, Kirsten AM, Waschki B, Rabe KF, Magnussen H, Kirsten D, Gramm M, Hummler S, Brunnemer E, Kreuter M, Watz H. Clinical Correlates of Reduced Physical Activity in Idiopathic Pulmonary Fibrosis. Respiration. 2016;91(6):497-502. doi: 10.1159/000446607. Epub 2016 Jun 1.

  PMID: 27240427 BACKGROUND

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Luis Diaz, MPH

CONTACT

813-396-2373; luisd2@usf.edu

Elisabeth Ballans, BSN

CONTACT

813-844-7609; eballans@tgh.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, observational, single arm

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: May 19, 2023
• Study Start: September 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2026
• Last Updated: December 15, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)