Impact of Physical Activity on Quality of Life in Lung Disease Patients After Treatment

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

This study is testing how physical activity affects the quality of life for people with lung diseases like idiopathic pulmonary fibrosis after they start treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: University of South Florida (Academic / other)
• Locations: 1 site (Tampa, Florida)
• Trial ID: NCT05866198 on ClinicalTrials.gov

What this trial studies

This prospective cohort study investigates the effects of physical activity on quality of life in patients with idiopathic pulmonary fibrosis (IPF) and other progressive fibrotic interstitial lung diseases (PF-ILD) after they begin anti-fibrotic therapy and pulmonary rehabilitation. Participants will wear an actigraphy watch to measure their physical activity levels, including daily steps and moderate-vigorous activity, over a 52-week period. The study aims to correlate these activity measurements with various health indicators, including quality of life assessments, pulmonary function tests, and disease progression markers. The findings could inform patient-centered care strategies and therapeutic targets.

Who should consider this trial

Good fit: Ideal candidates are adults over 40 years old recently diagnosed with PF-ILD or IPF who are willing to participate in pulmonary rehabilitation.

Not a fit: Patients who have completed pulmonary rehabilitation within the past year or have acute exacerbations or active lung infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the management of lung diseases by linking physical activity to improved quality of life and disease outcomes.

How similar studies have performed: While similar studies have explored the role of physical activity in chronic lung diseases, this specific approach using actigraphy in conjunction with anti-fibrotic therapy is relatively novel.

Eligibility criteria

Inclusion 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

Exclusion Criteria:

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.

Where this trial is running

Tampa, Florida

• University of South Florida/ Tampa General Hospital — Tampa, Florida, United States (Recruiting)

Study contacts

• Study coordinator: Luis Diaz, MPH

Conditions Lung Diseases, Interstitial; Progressive phenotype; anti-fibrotic therapy