Study of Pulmonary Rehabilitation in Patients With Idiopathic Pulmonary Fibrosis (IPF)

The main objectives of this study are:

  • Determine the difference in change from baseline in Six Minute Walk Distance (6MWD) when pulmonary rehabilitation (PR) is added to stable underlying nintedanib therapy in patients with idiopathic pulmonary fibrosis (IPF)
  • Determine the difference in change in Quality of Life (QoL) when pulmonary rehabilitation (PR) is added to stable underlying nintedanib therapy in patients with idiopathic pulmonary fibrosis (IPF)
  • Determine if there is an enduring effect in 6MWD, QoL and lung function from pulmonary rehabilitation (PR) when pulmonary rehabilitation (PR) is added to stable underlying nintedanib therapy in patients with idiopathic pulmonary fibrosis (IPF)

I'M INTERESTED

This research study is led by Dr. Victor Pinto-Plata.

Contact: Sherell Thornton-Thompson, 413-794-9056

Participation details:

BH18-200
Pulmonary/ Critical Care
Baystate Medical Center, 759 Chestnut St, Springfield, MA

Ages Eligible for Study: 40 Years and older (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion criteria:

  • Currently taking nintedanib, at a stable dose for 3-30 months
  • Age ≥ 40 years at screening
  • Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient consent form

Exclusion criteria:

  • Major surgery (major according to the investigator's assessment) performed within 12 weeks prior to randomization or planned within 6 months after screening, e.g. hip replacement which could interfere with the ability to participate in pulmonary rehabilitation.
  • Any documented active or suspected malignancy or history of malignancy within 3 years prior to screening, except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix
  • Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial
Recruiting
Interventional (Clinical Trial), Randomized
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