Pulmonary Rehabilitation in Idiopathic Pulmonary Fibrosis

Not Applicable

Completed

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Procedure: Pulmonary rehabilitation

• Registration Number: NCT03326089
• Lead Sponsor: Corfu General Hospital

Brief Summary

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

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 Timeline

• Study Start: 2017-06-01
• Study First Submitted: 2017-10-17
• Study First Submitted QC: 2017-10-25
• Study First Posted: 2017-10-30
• Status Verified: 2023-08
• Primary Completion: 2023-08-28
• Study Completion: 2023-08-28
• Last Update Submitted: 2023-08-28
• Last Update Posted: 2023-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High flow oxygen supplementation	Pulmonary rehabilitation	Pulmonary rehabilitation with constant high flow supplementary oxygen supply FiO2 50% for 2 months (Group A).
Oxygen supplementation upon hypoxemia	Pulmonary rehabilitation	Pulmonary rehabilitation without oxygen supply unless upon resting or exercise induced hypoxemia for 2 months (Group B).

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Corfu General Hospital; 🇬🇷 Corfu, Greece