Pulmonary Rehabilitation in Idiopathic Pulmonary Fibrosis

Corfu General Hospital

Status: Completed

Conditions: Idiopathic Pulmonary Fibrosis

Treatments: Procedure: Pulmonary rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT03326089

CorfuGH569

Details and patient eligibility

About

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.

Full 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).

Enrollment: 20 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

High flow oxygen supplementation

Active Comparator group

Description:

Pulmonary rehabilitation with constant high flow supplementary oxygen supply FiO2 50% for 2 months (Group A).

Treatment:

Procedure: Pulmonary rehabilitation

Oxygen supplementation upon hypoxemia

Placebo Comparator group

Description:

Pulmonary rehabilitation without oxygen supply unless upon resting or exercise induced hypoxemia for 2 months (Group B).

Treatment:

Procedure: Pulmonary rehabilitation