Pulmonary Rehabilitation in Idiopathic Pulmonary Fibrosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Idiopathic Pulmonary Fibrosis

Intervention / Treatment
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* Procedure: Pulmonary rehabilitation


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulmonary rehabilitation