Pulmonary Rehabilitation in Idiopathic Pulmonary Fibrosis

NCT ID: NCT03326089

Last Updated: 2023-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2023-08-28

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).

Conditions

Idiopathic Pulmonary Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

High flow oxygen supplementation

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

Group Type: ACTIVE_COMPARATOR

Pulmonary rehabilitation

Intervention Type: PROCEDURE

Endurance training for 30 minutes, 3 times/week for 2 months followed by resistance training

Oxygen supplementation upon hypoxemia

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

Group Type: PLACEBO_COMPARATOR

Pulmonary rehabilitation

Intervention Type: PROCEDURE

Endurance training for 30 minutes, 3 times/week for 2 months followed by resistance training

Interventions

Pulmonary rehabilitation

Endurance training for 30 minutes, 3 times/week for 2 months followed by resistance training

Intervention Type: PROCEDURE

Other Intervention Names

oxygen supplementation

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Corfu General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ilias Papanikolaou

Consultant Pulmonary Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stefanos Patsiris

Role: STUDY_DIRECTOR

Physiotherapy Director

Locations

Corfu General Hospital

Corfu, , Greece

Countries

Greece

Other Identifiers

CorfuGH569

Identifier Type: -

Identifier Source: org_study_id