IPFNCT07031362
The Effectiveness of Pulmonary Rehabilitation on Saturation in Patients With Idiopathic Pulmonary Fibrosis
A study testing EXERCISE TRAINING WITH OR WITHOUT MEDICATION in people with IPF and Pulmonary Fibrosis, run by Izmir Katip Celebi University.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IPF, Pulmonary Fibrosis
- What is being tested?
- EXERCISE TRAINING WITH OR WITHOUT MEDICATION
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Idiopathic Pulmonary Fibrosis Patients who initiated antifibrotic therapy Patients who completed the pulmonary rehabilitation program.
Who cannot join
- Kardiovascular comorbid conditions
About this study
Official title: Effects of Pulmonary Rehabilitation on Distance-Saturation Product and Clinical Outcomes in IPF Patients With and Without Exercise-Induced Desaturation
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).
Read the 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
- Being tested
- EXERCISE TRAINING WITH OR WITHOUT MEDICATION
- Keywords
- fibrosis, pulmonary rehabilitation, exercise training, saturation
- Medical subject headings
- Pulmonary Fibrosis, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXERCISE TRAINING WITH OR WITHOUT MEDICATIONOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Desaturated Patients | Active comparator | Patients whose oxygen saturation dropped to 88% or below during the pre-rehabilitation 6MWT were classified as the desaturation group Receives: 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. Receives: Other: EXERCISE TRAINING WITH OR WITHOUT MEDICATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise capacity
Six minute walk test
Measured: up to 8 weeks
Secondary outcomes (5)
Dyspnea Sensation
Modified Medical Research Council (MMRC)" dyspnea scale, which consists of 5 items ranging between 1 and 5, to determine the severity of patients' shortness of breath. Higher scores mean a worse outcome.
Measured: Before and after the pulmonary rehabilitation programme (up to 8 weeks)
Respiratory Functions
Pulmonary Function Test Pulmonary function test (PFT) which is noninvasive tests that show how well the lungs are working. The tests will measure FEV1; It is the volume of air (in liters) exhaled in the first second during forced exhalation after maximal inspiration.
FVC: It s the amount of air that can be forcibly exhaled from your lungs after taking the deepest breath possible, as measured by spirometry FEV1/FVC: It represents the proportion of a person's vital capacity that they are able to expire in the first second of forced expiration (FEV1) to the full, forced vital capacity (FVC).
Measured: Before and after the pulmonary rehabilitation programme (up to 8 weeks)
Disease Related Quality of Life Measurement
St. George's Respiratory Questionnaire (SGRQ) to determine disease-specific quality of life. At this scale, high scores define worsened disease and increased symptoms. Higher scores mean a worse outcome.
Measured: Before and after the pulmonary rehabilitation programme (up to 8 weeks)
Health-Related Quality of Life Measurement
Short Form-36 Survey is used to determine health-related quality of life. At this scale, high scores define a better perceived quality of life.
Measured: Before and after the pulmonary rehabilitation programme (up to 8 weeks)
Anxiety and Depression
Hospital Anxiety and Depression Inventory for assessment of anxiety and depression. In this scale; scores of anxiety and depression are calculated separately. The maximum score for both is 21 and high scores correspond to high degree anxiety and depression. Cut-off scores for anxiety and depression were determined as 10/11 and 7/8 respectively.
Measured: Before and after the pulmonary rehabilitation programme (up to 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start1 Jan 2013
- Primary completion30 Oct 2019
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IPFStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilknur Naz, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07031362
- Sponsor's protocol ID
- KKK333
- Status last verified
- Jun 2025
- First submitted
- 3 Jun 2025
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pulmonary Rehabilitation on Distance-Saturation Product and Clinical Outcomes in IPF Patients With and Without Exercise-Induced Desaturation
- ClinicalTrials.gov ID
- NCT07031362
- Acronym / sponsor ID
- KKK333
- Conditions
- IPF, Pulmonary Fibrosis
- Keywords
- fibrosis, pulmonary rehabilitation, exercise training, saturation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 22 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desaturated Patients | Active comparator | Other: EXERCISE TRAINING WITH OR WITHOUT MEDICATIONPatients whose oxygen saturation dropped to 88% or below during the pre-rehabilitation 6MWT were classified as the desaturation group |
| Non-desaturated group | Active comparator | Other: EXERCISE TRAINING WITH OR WITHOUT MEDICATIONThose with oxygen saturation of 89% or above were classified as the non-desaturation group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of Idiopathic Pulmonary Fibrosis Patients who initiated antifibrotic therapy Patients who completed the pulmonary rehabilitation program.
Key exclusion criteria (1 listed)
- Kardiovascular comorbid conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EXERCISE TRAINING WITH OR WITHOUT MEDICATIONAll 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. | Other | Desaturated Patients, Non-desaturated group |
Primary outcome
Exercise capacity
Time frame: up to 8 weeks
Six minute walk test
5 secondary outcomes
Dyspnea Sensation
Time frame: Before and after the pulmonary rehabilitation programme (up to 8 weeks)
Respiratory Functions
Time frame: Before and after the pulmonary rehabilitation programme (up to 8 weeks)
Disease Related Quality of Life Measurement
Time frame: Before and after the pulmonary rehabilitation programme (up to 8 weeks)
Health-Related Quality of Life Measurement
Time frame: Before and after the pulmonary rehabilitation programme (up to 8 weeks)
Anxiety and Depression
Time frame: Before and after the pulmonary rehabilitation programme (up to 8 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing EXERCISE TRAINING WITH OR WITHOUT MEDICATION in people with IPF and Pulmonary Fibrosis, run by Izmir Katip Celebi University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise capacity (time frame: up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2025.