The Effectiveness of Pulmonary Rehabilitation on Saturation in Patients With Idiopathic Pulmonary Fibrosis

NCT ID: NCT07031362

Last Updated: 2025-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-01
• Study Completion Date: 2025-05-01

Brief Summary

The aim of this study is to evaluate the effects of a pulmonary rehabilitation (PR) program on health outcomes and the distance-saturation product in patients with IPF, by comparing two distinct groups: those who experience desaturation and those who do not during the six-minute walk test (6MWT).

Detailed Description

Exercise-induced dyspnea and desaturation are distinguishing features of patients with idiopathic pulmonary fibrosis (IPF); these symptoms are associated with disease severity and poorer prognosis. The distance-saturation product, which combines the distance walked and oxygen saturation by multiplying the two measures, has been identified as a predictor of mortality.

Patients with IPF who completed the pulmonary rehabilitation (PR) program were included in the study. Pre- and post-program assessments included spirometric measurements, arterial blood gas values, perception of dyspnea using the Modified Medical Research Council (mMRC) dyspnea scale, exercise capacity via the six-minute walk test (6MWT), health-related quality of life using the St. George's Respiratory Questionnaire (SGRQ) and the Short Form-36 (SF-36), and psychological symptoms assessed with the Hospital Anxiety and Depression Scale (HADS). Additionally, the distance-saturation product was calculated by multiplying the distance walked by the oxygen saturation at the end of the 6MWT. Patients whose oxygen saturation dropped to 88% or below during the pre-rehabilitation 6MWT were classified as the desaturation group, while those with oxygen saturation of 89% or above were classified as the non-desaturation group. The obtained data were compared between these two groups.

Conditions

IPF; Pulmonary Fibrosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Desaturated Patients

Patients whose oxygen saturation dropped to 88% or below during the pre-rehabilitation 6MWT were classified as the desaturation group

Group Type: ACTIVE_COMPARATOR

EXERCISE TRAINING WITH OR WITHOUT MEDICATION

Intervention Type: OTHER

All patients who participated in the pulmonary rehabilitation and physiotherapy program underwent sessions lasting approximately two hours, conducted twice weekly over a period of eight weeks. The exercise program included breathing exercises, relaxation and stretching exercises, peripheral muscle strengthening exercises, and aerobic training.

Non-desaturated group

Those with oxygen saturation of 89% or above were classified as the non-desaturation group.

Group Type: ACTIVE_COMPARATOR

EXERCISE TRAINING WITH OR WITHOUT MEDICATION

Intervention Type: OTHER

All patients who participated in the pulmonary rehabilitation and physiotherapy program underwent sessions lasting approximately two hours, conducted twice weekly over a period of eight weeks. The exercise program included breathing exercises, relaxation and stretching exercises, peripheral muscle strengthening exercises, and aerobic training.

Interventions

EXERCISE TRAINING WITH OR WITHOUT MEDICATION

All patients who participated in the pulmonary rehabilitation and physiotherapy program underwent sessions lasting approximately two hours, conducted twice weekly over a period of eight weeks. The exercise program included breathing exercises, relaxation and stretching exercises, peripheral muscle strengthening exercises, and aerobic training.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Clinical diagnosis of Idiopathic Pulmonary Fibrosis Patients who initiated antifibrotic therapy Patients who completed the pulmonary rehabilitation program.

Exclusion Criteria

• Kardiovascular comorbid conditions

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Izmir Katip Celebi University

OTHER

Sponsor Role: lead

Responsible Party

Ilknur Naz

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

KKK333

Identifier Type: -

Identifier Source: org_study_id