Idiopathic Pulmonary FibrosisNCT03326089
Pulmonary Rehabilitation in Idiopathic Pulmonary Fibrosis
A study testing Pulmonary rehabilitation in people with Idiopathic Pulmonary Fibrosis, run by Corfu General Hospital at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- Pulmonary rehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jun 2017to 28 Aug 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- concomitant diagnosis of congestive heart failure and lung cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short and Long-term Effects of Oxygen Supplemented Pulmonary Rehabilitation in Idiopathic Pulmonary Fibrosis
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.
Read the 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
- Being tested
- Pulmonary rehabilitation
- Keywords
- pulmonary rehabilitation
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary rehabilitationProcedure or surgery
Also called oxygen supplementation
Endurance training for 30 minutes, 3 times/week for 2 months followed by resistance training
| Study group | Role | What they receive |
|---|---|---|
| High flow oxygen supplementation | Active comparator | Pulmonary rehabilitation with constant high flow supplementary oxygen supply FiO2 50% for 2 months (Group A). Receives: Procedure: Pulmonary rehabilitation |
| Oxygen supplementation upon hypoxemia | Placebo comparator | Pulmonary rehabilitation without oxygen supply unless upon resting or exercise induced hypoxemia for 2 months (Group B). Receives: Procedure: Pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Minute Walk Test Distance (6MWTD) (meters)
Statistically significant short term effect on exercise capacity
Measured: 2 months
Saint-George Respiratory Questionnaire Idiopathic Pulmonary Fibrosis Version (SGRQ-I) (units on scale)
Statistically significant short term effect on health related quality of life
Measured: 2 months
Hospital Anxiety and Depression Scale (HADS) (units on scale)
Statistically significant short term effect on health related quality of life
Measured: 2 months
Secondary outcomes (3)
6 Minute Walk Test Distance (6MWTD) (meters)
Statistically significant long term effect on exercise capacity
Measured: 12 months
Saint-George Respiratory Questionnaire Idiopathic Pulmonary Fibrosis Version (SGRQ-I) (units on scale)
Statistically significant long term effect on health related quality of life
Measured: 12 months
Hospital Anxiety and Depression Scale (HADS) (units on scale)
Statistically significant long term effect on health related quality of life
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study start1 Jun 2017
- Primary completion28 Aug 2023
- Study completion28 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corfu General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilias Papanikolaou, Corfu General Hospital
- Investigators
- Stefanos Patsiris, Study director, Physiotherapy Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03326089
- Sponsor's protocol ID
- CorfuGH569
- Status last verified
- Aug 2023
- First submitted
- 17 Oct 2017
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Everything will be published in time.
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short and Long-term Effects of Oxygen Supplemented Pulmonary Rehabilitation in Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT03326089
- Acronym / sponsor ID
- CorfuGH569
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- pulmonary rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Corfu General HospitalUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 28 Aug 2023 (actual)
- Study completion
- 28 Aug 2023 (actual)
- First posted
- 30 Oct 2017 (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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High flow oxygen supplementation | Active comparator | Procedure: Pulmonary rehabilitationPulmonary rehabilitation with constant high flow supplementary oxygen supply FiO2 50% for 2 months (Group A). |
| Oxygen supplementation upon hypoxemia | Placebo comparator | Procedure: Pulmonary rehabilitationPulmonary rehabilitation without oxygen supply unless upon resting or exercise induced hypoxemia for 2 months (Group B). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- concomitant diagnosis of congestive heart failure and lung cancer.
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 |
|---|---|---|
| Pulmonary rehabilitationAlso: oxygen supplementationEndurance training for 30 minutes, 3 times/week for 2 months followed by resistance training | Procedure or surgery | High flow oxygen supplementation, Oxygen supplementation upon hypoxemia |
Primary outcome
6 Minute Walk Test Distance (6MWTD) (meters)
Time frame: 2 months
Statistically significant short term effect on exercise capacity
Saint-George Respiratory Questionnaire Idiopathic Pulmonary Fibrosis Version (SGRQ-I) (units on scale)
Time frame: 2 months
Statistically significant short term effect on health related quality of life
Hospital Anxiety and Depression Scale (HADS) (units on scale)
Time frame: 2 months
Statistically significant short term effect on health related quality of life
3 secondary outcomes
6 Minute Walk Test Distance (6MWTD) (meters)
Time frame: 12 months
Saint-George Respiratory Questionnaire Idiopathic Pulmonary Fibrosis Version (SGRQ-I) (units on scale)
Time frame: 12 months
Hospital Anxiety and Depression Scale (HADS) (units on scale)
Time frame: 12 months
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 30 Aug 2023.
- Individual participant dataSharing planned: Undecided. Everything will be published in time.
Related trials for Idiopathic Pulmonary Fibrosis
RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
RecruitingPhase 2
An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)
Progressive Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis (IPF)
RecruitingObservational study
Real-world Study of Nerandomilast in Patients With Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis
RecruitingPhase 2
A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
Not yet recruitingPhase 2
A Phase 2 Study of HB0056 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
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.
Stefanos Patsiris study director
Physiotherapy Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary rehabilitation in people with Idiopathic Pulmonary Fibrosis, run by Corfu General Hospital at 1 site in Greece.
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 4 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 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
6 Minute Walk Test Distance (6MWTD) (meters) (time frame: 2 months). The study lists 3 primary outcomes in all. 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 30 Aug 2023.