Idiopathic Pulmonary FibrosisNCT05353556
Effects of Home-based Inspiratory Muscle Training in Patients With IPF
A study testing Inspiratory Muscle Training (IMT) in people with Idiopathic Pulmonary Fibrosis and IPF, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effects of the home-based inspiratory muscle training program on lung functions, dyspnea, inspiratory muscle strength, functional capacity and quality of life in patients with idiopathic pulmonary fibrosis. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis, IPF
- What is being tested?
- Inspiratory Muscle Training (IMT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Feb 2022to 30 May 2022
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosing Idiopathic Pulmonary Fibrosis by a pulmonologist;
- Aged between 40 and 75 years;
- Volunteering to research;
- Stable clinical condition (same medication routine and/or no acute exacerbation in the last for the last 4 weeks).
Who cannot join
- Inability of the participant to understand or perform the procedures proposed during the evaluations or training program.
- Participating in any pulmonary rehabilitation programs;
- A previous pneumonectomy or lobectomy operation;
- Pneumonia in the last 4 weeks;
- Any pulmonary infection during the study;
- Requirement for supplemental oxygen therapy while resting.
- Having Covid-19 disease (during the study or in the past)
- Orthopaedic or neurological conditions affecting the ability to independent walking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Home-based Inspiratory Muscle Training in Patients With Idiopathic Pulmonary Fibrosis
The aim of this study is to investigate the effects of the home-based inspiratory muscle training program on lung functions, dyspnea, inspiratory muscle strength, functional capacity and quality of life in patients with idiopathic pulmonary fibrosis. Patients are evaluated before the inspiratory muscle training and after 8 weeks of training.
Read the detailed description
The IMT protocol consisted of home-based high-intensity daily training - two cycles of 30 breaths with a 1-min rest between sets, twice a day for 8 weeks using an IMT Threshold device (Threshold IMT Philips® Respironics, Inc). The intensity of the training was set to 50% of each patient's maximal inspiratory pressure measured every week and was adjusted weekly based on the modified Borg scale from 4 to 6 regarding respiratory effort performed during the session. Patients are evaluated before the inspiratory muscle training and after 8 weeks of training.
- Conditions
- Idiopathic Pulmonary Fibrosis, IPF
- Being tested
- Inspiratory Muscle Training (IMT), Sham IMT
- Keywords
- idiopathic pulmonary fibrosis, inspiratory muscle training, home-based, 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.
Inspiratory Muscle Training (IMT)Device
The IMT protocol will consist of home-based high-intensity daily training - two cycles of 30 breaths with a 1-min rest between sets, twice a day for 8 weeks using an IMT Threshold device (Threshold IMT Philips® Respironics, Inc). The intensity of the training will be set to 50% of each patient's maximal inspiratory pressure measured every week and was adjusted weekly based on the modified Borg scale from 4 to 6 regarding respiratory effort performed during the session.
Sham IMTDevice
The IMT protocol will consist of home-based daily training - two cycles of 30 breaths with a 1-min rest between sets, twice a day for 8 weeks using an IMT Threshold device (Threshold IMT Philips® Respironics, Inc). The intensity of the training will be set to the lowest intensity of the IMT Threshold device.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Patients who perform inspiratory muscle training (IMT) with %50 loading Receives: Device: Inspiratory Muscle Training (IMT) |
| Sham Group | Sham comparator | Patients who perform Sham IMT Receives: Device: Sham IMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in inspiratory muscle strength
MIP
Measured: 8 weeks
Secondary outcomes (5)
Change in percentages of forced expiratory volume in one second
Lung function tests: Percentages of forced expiratory volume in one second (FEV1).
Measured: 8 weeks
Change in percentages of forced vital capacity
Lung function tests: Percentages of forced vital capacity (FVC).
Measured: 8 weeks
Change in diffusing capacity of the lung for carbon monoxide
Lung function tests: Diffusing capacity of the lung for carbon monoxide (DLCO).
Measured: 8 weeks
Change in Dyspnea
The modified Medical Research Council (mMRC) Dyspnea Scale was used to evaluate the severity of dyspnea. Commonly used in the assessment of dyspnea in COPD, mMRC has a five-level scoring system ranging from 0 to 4. A high score indicates an increased sense of dyspnea.
Measured: 8 weeks
Change in Functional capacity
Maximal distance in 6 minute walk test
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start21 Feb 2022
- Primary completion25 Apr 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Model description
- This study was designed as a prospective and experimental study. Participants were randomly divided into two groups; a study group and a control group. The study group will perform inspiratory muscle training at 50% of maximal inspiratory pressure (MIP), and the control group received sham training for 8 weeks.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ridvan Aktan, Izmir University of Economics
- Investigators
- Rıdvan Aktan, PhD, Principal investigator, Izmir University of Economics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05353556
- Sponsor's protocol ID
- RidvanAktan_2022/04-03
- Status last verified
- Jan 2024
- First submitted
- 25 Apr 2022
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Selman M, Thannickal VJ, Pardo A, Zisman DA, Martinez FJ, Lynch JP 3rd. Idiopathic pulmonary fibrosis: pathogenesis and therapeutic approaches. Drugs. 2004;64(4):405-30. doi: 10.2165/00003495-200464040-00005.
PubMed 14969575Jastrzebski D, Kozielski J, Zebrowska A. [Pulmonary rehabilitation in patients with idiopathic pulmonary fibrosis with inspiratory muscle training]. Pneumonol Alergol Pol. 2008;76(3):131-41. Polish.
PubMed 18843927Kagaya H, Takahashi H, Sugawara K, Kasai C, Kiyokawa N, Shioya T. Effective home-based pulmonary rehabilitation in patients with restrictive lung diseases. Tohoku J Exp Med. 2009 Jul;218(3):215-9. doi: 10.1620/tjem.218.215.
PubMed 19561392Tzanakis N, Samiou M, Lambiri I, Antoniou K, Siafakas N, Bouros D. Evaluation of health-related quality-of-life and dyspnea scales in patients with idiopathic pulmonary fibrosis. Correlation with pulmonary function tests. Eur J Intern Med. 2005 Apr;16(2):105-112. doi: 10.1016/j.ejim.2004.09.013.
PubMed 15833676Peng S, Li Z, Kang J, Hou X. Cross-sectional and longitudinal construct validity of the Saint George's Respiratory Questionnaire in patients with IPF. Respirology. 2008 Nov;13(6):871-9. doi: 10.1111/j.1440-1843.2008.01359.x.
PubMed 18811886Aktan R, Tertemiz KC, Yigit S, Ozalevli S, Ozgen Alpaydin A, Ucan ES. Effects of home-based telerehabilitation-assisted inspiratory muscle training in patients with idiopathic pulmonary fibrosis: A randomized controlled trial. Respirology. 2024 Dec;29(12):1077-1084. doi: 10.1111/resp.14810. Epub 2024 Aug 11.
PubMed 39129185
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Home-based Inspiratory Muscle Training in Patients With Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT05353556
- Acronym / sponsor ID
- RidvanAktan_2022/04-03
- Conditions
- Idiopathic Pulmonary Fibrosis, IPF
- Keywords
- idiopathic pulmonary fibrosis, inspiratory muscle training, home-based, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 21 Feb 2022 (actual)
- Primary completion
- 25 Apr 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 29 Apr 2022 (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 investigate the effects of the home-based inspiratory muscle training program on lung functions, dyspnea, inspiratory muscle strength, functional capacity and quality of life in patients with idiopathic pulmonary fibrosis. Patients are evaluated before the inspiratory muscle training and after 8 weeks of training.
Detailed description
The IMT protocol consisted of home-based high-intensity daily training - two cycles of 30 breaths with a 1-min rest between sets, twice a day for 8 weeks using an IMT Threshold device (Threshold IMT Philips® Respironics, Inc). The intensity of the training was set to 50% of each patient's maximal inspiratory pressure measured every week and was adjusted weekly based on the modified Borg scale from 4 to 6 regarding respiratory effort performed during the session. Patients are evaluated before the inspiratory muscle training and after 8 weeks of training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This study was designed as a prospective and experimental study. Participants were randomly divided into two groups; a study group and a control group. The study group will perform inspiratory muscle training at 50% of maximal inspiratory pressure (MIP), and the control group received sham training for 8 weeks.
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Device: Inspiratory Muscle Training (IMT)Patients who perform inspiratory muscle training (IMT) with %50 loading |
| Sham Group | Sham comparator | Device: Sham IMTPatients who perform Sham IMT |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosing Idiopathic Pulmonary Fibrosis by a pulmonologist;
- Aged between 40 and 75 years;
- Volunteering to research;
- Stable clinical condition (same medication routine and/or no acute exacerbation in the last for the last 4 weeks).
Key exclusion criteria (8 listed)
- Inability of the participant to understand or perform the procedures proposed during the evaluations or training program.
- Participating in any pulmonary rehabilitation programs;
- A previous pneumonectomy or lobectomy operation;
- Pneumonia in the last 4 weeks;
- Any pulmonary infection during the study;
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 |
|---|---|---|
| Inspiratory Muscle Training (IMT)The IMT protocol will consist of home-based high-intensity daily training - two cycles of 30 breaths with a 1-min rest between sets, twice a day for 8 weeks using an IMT Threshold device (Threshold IMT Philips® Respironics, Inc). The intensity of the training will be set to 50% of each patient's maximal inspiratory pressure measured every week and was adjusted weekly based on the modified Borg scale from 4 to 6 regarding respiratory effort performed during the session. | Device | Study Group |
| Sham IMTThe IMT protocol will consist of home-based daily training - two cycles of 30 breaths with a 1-min rest between sets, twice a day for 8 weeks using an IMT Threshold device (Threshold IMT Philips® Respironics, Inc). The intensity of the training will be set to the lowest intensity of the IMT Threshold device. | Device | Sham Group |
Primary outcome
Change in inspiratory muscle strength
Time frame: 8 weeks
MIP
5 secondary outcomes
Change in percentages of forced expiratory volume in one second
Time frame: 8 weeks
Change in percentages of forced vital capacity
Time frame: 8 weeks
Change in diffusing capacity of the lung for carbon monoxide
Time frame: 8 weeks
Change in Dyspnea
Time frame: 8 weeks
Change in Functional capacity
Time frame: 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 10 Jan 2024.
- Background: PubMed 14969575Selman M, Thannickal VJ, Pardo A, Zisman DA, Martinez FJ, Lynch JP 3rd. Idiopathic pulmonary fibrosis: pathogenesis and therapeutic approaches. Drugs. 2004;64(4):405-30. doi: 10.2165/00003495-200464040-00005.
- Background: PubMed 18843927Jastrzebski D, Kozielski J, Zebrowska A. [Pulmonary rehabilitation in patients with idiopathic pulmonary fibrosis with inspiratory muscle training]. Pneumonol Alergol Pol. 2008;76(3):131-41. Polish.
- Background: PubMed 19561392Kagaya H, Takahashi H, Sugawara K, Kasai C, Kiyokawa N, Shioya T. Effective home-based pulmonary rehabilitation in patients with restrictive lung diseases. Tohoku J Exp Med. 2009 Jul;218(3):215-9. doi: 10.1620/tjem.218.215.
- Background: PubMed 15833676Tzanakis N, Samiou M, Lambiri I, Antoniou K, Siafakas N, Bouros D. Evaluation of health-related quality-of-life and dyspnea scales in patients with idiopathic pulmonary fibrosis. Correlation with pulmonary function tests. Eur J Intern Med. 2005 Apr;16(2):105-112. doi: 10.1016/j.ejim.2004.09.013.
- Background: PubMed 18811886Peng S, Li Z, Kang J, Hou X. Cross-sectional and longitudinal construct validity of the Saint George's Respiratory Questionnaire in patients with IPF. Respirology. 2008 Nov;13(6):871-9. doi: 10.1111/j.1440-1843.2008.01359.x.
- Derived from this study: PubMed 39129185Aktan R, Tertemiz KC, Yigit S, Ozalevli S, Ozgen Alpaydin A, Ucan ES. Effects of home-based telerehabilitation-assisted inspiratory muscle training in patients with idiopathic pulmonary fibrosis: A randomized controlled trial. Respirology. 2024 Dec;29(12):1077-1084. doi: 10.1111/resp.14810. Epub 2024 Aug 11.
- 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.
Rıdvan Aktan, PhD principal investigator
Izmir University of Economics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory Muscle Training (IMT) in people with Idiopathic Pulmonary Fibrosis and IPF, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
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 8 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 10 Jan 2024. 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 Turkey (Türkiye). 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?
Change in inspiratory muscle strength (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05353556, which also lists 6 linked publications.
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 10 Jan 2024.