NCT07031362

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
5.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 3, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 22, 2025

Completed
Last Updated

June 22, 2025

Status Verified

June 1, 2025

Enrollment Period

6.8 years

First QC Date

June 3, 2025

Last Update Submit

June 18, 2025

Conditions

Keywords

fibrosispulmonary rehabilitationexercise trainingsaturation

Outcome Measures

Primary Outcomes (1)

  • Exercise capacity

    Six minute walk test

    up to 8 weeks

Secondary Outcomes (5)

  • Dyspnea Sensation

    Before and after the pulmonary rehabilitation programme (up to 8 weeks)

  • Respiratory Functions

    Before and after the pulmonary rehabilitation programme (up to 8 weeks)

  • Disease Related Quality of Life Measurement

    Before and after the pulmonary rehabilitation programme (up to 8 weeks)

  • Health-Related Quality of Life Measurement

    Before and after the pulmonary rehabilitation programme (up to 8 weeks)

  • Anxiety and Depression

    Before and after the pulmonary rehabilitation programme (up to 8 weeks)

Study Arms (2)

Desaturated Patients

ACTIVE COMPARATOR

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

Other: EXERCISE TRAINING WITH OR WITHOUT MEDICATION

Non-desaturated group

ACTIVE COMPARATOR

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

Other: EXERCISE TRAINING WITH OR WITHOUT MEDICATION

Interventions

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.

Desaturated PatientsNon-desaturated group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Kardiovascular comorbid conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary FibrosisFibrosis

Interventions

ExerciseDosage Forms

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaPharmaceutical PreparationsTechnology, PharmaceuticalInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

June 3, 2025

First Posted

June 22, 2025

Study Start

January 1, 2013

Primary Completion

October 30, 2019

Study Completion

May 1, 2025

Last Updated

June 22, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share