Pulmonary Rehabilitation in Idiopathic Pulmonary Fibrosis

Short and Long-term Effects of Oxygen Supplemented Pulmonary Rehabilitation in Idiopathic Pulmonary Fibrosis

This is an interventional double-blind randomized controlled trial, to investigate the short and long-term effects of a supervised exercise training program in patients with IPF, depending on alternate patterns of oxygen supplementation during PR.

Study Overview

• Status: Completed
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Procedure: Pulmonary rehabilitation

Detailed Description

The investigators hypothesize that PR service with supplemented oxygen supply regardless of hypoxemia may have significantly better short-term effects in patients with IPF. The study will take place in Corfu General Hospital, by the Departments of Pulmonary Medicine and Physiotherapy and Rehabilitation, respectively. Study participants will be divided in two equal arms 1:1 in a double-blind manner. One of the investigators blinded to their clinical data will assign each participant to PR service either i) with constant supplementary oxygen supply FiO2 50% regardless of saturation status Group A) or ii) without oxygen supply unless upon resting or exercise induced hypoxemia (saturation <88%) (Group B).

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Corfu, Greece, 49100
    • Corfu General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• diagnosis of IPF based on current established criteria
• no exacerbation previous 3 months
• no participation in such program previous 3 months.
• If on treatment with pirfenidone or nintedanib, this will be recorded and patient should be on treatment for at least 3-6 months to achieve stable state.

Exclusion Criteria:

- concomitant diagnosis of congestive heart failure and lung cancer.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: High flow oxygen supplementation; Pulmonary rehabilitation with constant high flow supplementary oxygen supply FiO2 50% for 2 months (Group A).	Procedure: Pulmonary rehabilitation; Endurance training for 30 minutes, 3 times/week for 2 months followed by resistance training; Other Names: oxygen supplementation
Placebo Comparator: Oxygen supplementation upon hypoxemia; Pulmonary rehabilitation without oxygen supply unless upon resting or exercise induced hypoxemia for 2 months (Group B).	Procedure: Pulmonary rehabilitation; Endurance training for 30 minutes, 3 times/week for 2 months followed by resistance training; Other Names: oxygen supplementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 Minute Walk Test Distance (6MWTD) (meters)	Statistically significant short term effect on exercise capacity	2 months
Saint-George Respiratory Questionnaire Idiopathic Pulmonary Fibrosis Version (SGRQ-I) (units on scale)	Statistically significant short term effect on health related quality of life	2 months
Hospital Anxiety and Depression Scale (HADS) (units on scale)	Statistically significant short term effect on health related quality of life	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 Minute Walk Test Distance (6MWTD) (meters)	Statistically significant long term effect on exercise capacity	12 months
Saint-George Respiratory Questionnaire Idiopathic Pulmonary Fibrosis Version (SGRQ-I) (units on scale)	Statistically significant long term effect on health related quality of life	12 months
Hospital Anxiety and Depression Scale (HADS) (units on scale)	Statistically significant long term effect on health related quality of life	12 months

Collaborators and Investigators

• Sponsor: Corfu General Hospital
• Investigators: Study Director: Stefanos Patsiris, Physiotherapy Director

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): August 28, 2023
• Study Completion (Actual): August 28, 2023

Study Registration Dates

• First Submitted: October 17, 2017
• First Submitted That Met QC Criteria: October 25, 2017
• First Posted (Actual): October 30, 2017

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: pulmonary rehabilitation
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: CorfuGH569

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Everything will be published in time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No