Pulmonary Rehabilitation in Idiopathic Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03326089
• Other study ID #: CorfuGH569
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: August 28, 2023

Study information

• Verified date: August 2023
• Source: Corfu General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 28, 2023
• Est. primary completion date: August 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Procedure:
• Pulmonary rehabilitation
Endurance training for 30 minutes, 3 times/week for 2 months followed by resistance training

Locations

Country	Name	City	State
Greece	Corfu General Hospital	Corfu

Sponsors (1)

Lead Sponsor	Collaborator
Corfu General Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 Minute Walk Test Distance (6MWTD) (meters)	Statistically significant short term effect on exercise capacity	2 months
Primary	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
Primary	Hospital Anxiety and Depression Scale (HADS) (units on scale)	Statistically significant short term effect on health related quality of life	2 months
Secondary	6 Minute Walk Test Distance (6MWTD) (meters)	Statistically significant long term effect on exercise capacity	12 months
Secondary	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
Secondary	Hospital Anxiety and Depression Scale (HADS) (units on scale)	Statistically significant long term effect on health related quality of life	12 months