SmokersNCT07200895
Acute IMT Intensity Effects in Male Smokers
A study testing Inspiratory Muscle Training (30% MIP) and Inspiratory Muscle Training (60% MIP) in people with Smokers, run by FATMA DİLARA AKAR ÇAMYAR at 1 site in Turkey (Türkiye).
Trial summary
Acute IMT Intensity Effects in Male Smokers Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Smokers
- What is being tested?
- Inspiratory Muscle Training (30% MIP) and Inspiratory Muscle Training (60% MIP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2025to 1 Jan 2026
- 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 to 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male, 18-25 years of age.
- Current cigarette smoker for ≥1 year (regular use).
- No known acute or chronic medical condition.
Who cannot join
- History of any musculoskeletal injury that may limit participation.
- History of chest pain during physical activity.
- Current use of any medication.
- Symptoms of dizziness or balance loss.
- Diagnosis of hemophilia or history of vascular/cardiovascular disease affecting circulation.
- Presence of any acute illness at screening or on the test day.
- Inability to complete the procedures due to physical limitation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Acute Effects of Inspiratory Muscle Training at Different Intensities on Vital Signs and Peripheral and Respiratory Muscle Strength in Male Smokers
Acute IMT Intensity Effects in Male Smokers
Read the detailed description
Cigarette smoking can impair respiratory muscle function by reducing inspiratory strength and endurance; Inspiratory Muscle Training (IMT) is a rehabilitative strategy that uses resistive breathing to strengthen the diaphragm and accessory inspiratory muscles. It may temporarily influence autonomic responses and muscle performance. This randomised, parallel-group study will investigate the immediate effects of two IMT intensities in male smokers. Thirty-four male participants who currently smoke will be randomly assigned to one of two groups: IMT at 30% of maximal inspiratory pressure (MIP) or IMT at 60% of MIP. Prior to IMT, all participants will complete a standardised diaphragmatic breathing warm-up (3 sets of 10 repetitions; approximately 5 minutes). IMT will be administered with a threshold device (e. g., Powerbreathe®), with each group performing 3 sets of 30 breaths at the assigned intensity over approximately 15 minutes under supervision. Participants will be monitored for transient discomfort or fatigue. Outcomes will be assessed immediately before and after the session. These will include respiratory muscle strength (MIP, maximal expiratory pressure, MEP), peripheral muscle performance (handgrip strength in both dominant and non-dominant hands), and vital signs (heart rate, oxygen saturation, respiratory rate, systolic and diastolic blood pressure), along with perceived exertion using the Borg scale. The primary outcome will be a change in MIP (cmH₂O and % predicted); secondary outcomes will include changes in MEP, handgrip strength, vital signs, and perceived exertion. Data will be analysed using appropriate paired and independent tests (parametric or non-parametric based on distributional checks) in IBM SPSS v 27. By comparing low- and higher-intensity IMT within a single supervised session, the study aims to identify a practical early-intervention intensity that can acutely enhance inspiratory muscle function in male smokers and potentially inform broader pulmonary rehabilitation strategies.
- Conditions
- Smokers
- Being tested
- Inspiratory Muscle Training (30% MIP), Inspiratory Muscle Training (60% MIP)
- Keywords
- Inspiratory muscle training, breathing exercise, respiratory muscle strength, smoking
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Muscle Training (30% MIP)Device
Single supervised session of threshold-loaded inspiratory muscle training set at 30% of baseline maximal inspiratory pressure (MIP); 3 sets × 30 breaths (~15 minutes) following a standardized diaphragmatic-breathing warm-up.
Inspiratory Muscle Training (60% MIP)Device
Single supervised session of threshold-loaded inspiratory muscle training set at 60% of baseline maximal inspiratory pressure (MIP); 3 sets × 30 breaths (~15 minutes) following the same standardized warm-up.
| Study group | Role | What they receive |
|---|---|---|
| 30% MIP IMT | Experimental | Single supervised session of inspiratory muscle training at 30% of maximal inspiratory pressure (MIP) using a threshold device; 3 sets × 30 breaths (~15 minutes) following a standardized diaphragmatic-breathing warm-up. Receives: Device: Inspiratory Muscle Training (30% MIP) |
| 60% MIP IMT | Experimental | Single supervised session of inspiratory muscle training at 60% of maximal inspiratory pressure (MIP) using a threshold device; 3 sets × 30 breaths (~15 minutes) following the same standardized warm-up. Receives: Device: Inspiratory Muscle Training (60% MIP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Maximal Inspiratory Pressure (MIP), cmH₂O and % predicted
MIP will be measured using a calibrated mouth pressure meter/threshold device per standard procedures with a nose clip and from residual volume. The primary endpoint is the within-participant change (post-pre) expressed in cmH₂O and as % predicted based on reference equations. Higher values indicate greater inspiratory muscle strength.
Measured: Baseline (pre-session) to immediately post-session (within ~5 minutes after IMT)
Secondary outcomes (3)
Change in Maximal Expiratory Pressure (MEP), cmH₂O and % predicted
MEP will be assessed with the same device from total lung capacity. Endpoint is post-pre change (cmH₂O and % predicted). Higher values indicate greater expiratory muscle strength.
Measured: Baseline to immediately post-session
Change in Handgrip Strength (dominant and non-dominant), kg
Assessed with a calibrated hand dynamometer (e.g., Jamar). Best of three trials for each hand recorded. Endpoint is post-pre change (kg).
Measured: Baseline to immediately post-session
Change in Heart Rate, Change in Respiratory Rate, Change in Oxygen Saturation, Change in Systolic and Diastolic Blood Pressure, Change in Perceived Exertion
- Measured at rest using a pulse oximeter or cardiac monitor after 3-5 minutes seated rest. Endpoint is post-pre change (bpm).
- Counted over 60 seconds at rest. Endpoint is post-pre change (breaths/min).
- Measured by pulse oximetry with the participant seated and at rest. Endpoint is post-pre change (%).
- Automated sphygmomanometer, seated, appropriate cuff size, two readings averaged if needed. Endpoint is post-pre change (mmHg).
- Global rating of exertion collected at rest (pre) and within 1-2 minutes after IMT. Endpoint is post-pre change (points).
Measured: Baseline to immediately post-session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start1 Oct 2025
- Primary completion1 Dec 2025
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SmokersStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- FATMA DİLARA AKAR ÇAMYAR
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, FATMA DİLARA AKAR ÇAMYAR, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07200895
- Sponsor's protocol ID
- BiruniU-IMT2025
- Status last verified
- Feb 2026
- First submitted
- 23 Sep 2025
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The team is evaluating repository options and consent language for de-identified IPD sharing.
Publications
Tanriverdi A, Kahraman BO, Ozsoy I, Ozpelit E, Savci S. Acute effects of inspiratory muscle training at different intensities in healthy young people. Ir J Med Sci. 2021 May;190(2):577-585. doi: 10.1007/s11845-020-02353-w. Epub 2020 Aug 26.
PubMed 32851483Rodrigues F, Araujo AA, Mostarda CT, Ferreira J, de Barros Silva MC, Nascimento AM, Lira FS, De Angelis K, Irigoyen MC, Rodrigues B. Autonomic changes in young smokers: acute effects of inspiratory exercise. Clin Auton Res. 2013 Aug;23(4):201-7. doi: 10.1007/s10286-013-0202-1. Epub 2013 Jun 28.
PubMed 23812534
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Acute Effects of Inspiratory Muscle Training at Different Intensities on Vital Signs and Peripheral and Respiratory Muscle Strength in Male Smokers
- ClinicalTrials.gov ID
- NCT07200895
- Acronym / sponsor ID
- BiruniU-IMT2025
- Conditions
- Smokers
- Keywords
- Inspiratory muscle training, breathing exercise, respiratory muscle strength, smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- FATMA DİLARA AKAR ÇAMYARUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 1 Oct 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.
Acute IMT Intensity Effects in Male Smokers
Detailed description
Cigarette smoking can impair respiratory muscle function by reducing inspiratory strength and endurance; Inspiratory Muscle Training (IMT) is a rehabilitative strategy that uses resistive breathing to strengthen the diaphragm and accessory inspiratory muscles. It may temporarily influence autonomic responses and muscle performance. This randomised, parallel-group study will investigate the immediate effects of two IMT intensities in male smokers. Thirty-four male participants who currently smoke will be randomly assigned to one of two groups: IMT at 30% of maximal inspiratory pressure (MIP) or IMT at 60% of MIP. Prior to IMT, all participants will complete a standardised diaphragmatic breathing warm-up (3 sets of 10 repetitions; approximately 5 minutes). IMT will be administered with a threshold device (e. g., Powerbreathe®), with each group performing 3 sets of 30 breaths at the assigned intensity over approximately 15 minutes under supervision. Participants will be monitored for transient discomfort or fatigue. Outcomes will be assessed immediately before and after the session. These will include respiratory muscle strength (MIP, maximal expiratory pressure, MEP), peripheral muscle performance (handgrip strength in both dominant and non-dominant hands), and vital signs (heart rate, oxygen saturation, respiratory rate, systolic and diastolic blood pressure), along with perceived exertion using the Borg scale. The primary outcome will be a change in MIP (cmH₂O and % predicted); secondary outcomes will include changes in MEP, handgrip strength, vital signs, and perceived exertion. Data will be analysed using appropriate paired and independent tests (parametric or non-parametric based on distributional checks) in IBM SPSS v 27. By comparing low- and higher-intensity IMT within a single supervised session, the study aims to identify a practical early-intervention intensity that can acutely enhance inspiratory muscle function in male smokers and potentially inform broader pulmonary rehabilitation strategies.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 30% MIP IMT | Experimental | Device: Inspiratory Muscle Training (30% MIP)Single supervised session of inspiratory muscle training at 30% of maximal inspiratory pressure (MIP) using a threshold device; 3 sets × 30 breaths (~15 minutes) following a standardized diaphragmatic-breathing warm-up. |
| 60% MIP IMT | Experimental | Device: Inspiratory Muscle Training (60% MIP)Single supervised session of inspiratory muscle training at 60% of maximal inspiratory pressure (MIP) using a threshold device; 3 sets × 30 breaths (~15 minutes) following the same standardized warm-up. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male, 18-25 years of age.
- Current cigarette smoker for ≥1 year (regular use).
- No known acute or chronic medical condition.
Key exclusion criteria (7 listed)
- History of any musculoskeletal injury that may limit participation.
- History of chest pain during physical activity.
- Current use of any medication.
- Symptoms of dizziness or balance loss.
- Diagnosis of hemophilia or history of vascular/cardiovascular disease affecting circulation.
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 (30% MIP)Single supervised session of threshold-loaded inspiratory muscle training set at 30% of baseline maximal inspiratory pressure (MIP); 3 sets × 30 breaths (~15 minutes) following a standardized diaphragmatic-breathing warm-up. | Device | 30% MIP IMT |
| Inspiratory Muscle Training (60% MIP)Single supervised session of threshold-loaded inspiratory muscle training set at 60% of baseline maximal inspiratory pressure (MIP); 3 sets × 30 breaths (~15 minutes) following the same standardized warm-up. | Device | 60% MIP IMT |
Primary outcome
Change in Maximal Inspiratory Pressure (MIP), cmH₂O and % predicted
Time frame: Baseline (pre-session) to immediately post-session (within ~5 minutes after IMT)
MIP will be measured using a calibrated mouth pressure meter/threshold device per standard procedures with a nose clip and from residual volume. The primary endpoint is the within-participant change (post-pre) expressed in cmH₂O and as % predicted based on reference equations. Higher values indicate greater inspiratory muscle strength.
3 secondary outcomes
Change in Maximal Expiratory Pressure (MEP), cmH₂O and % predicted
Time frame: Baseline to immediately post-session
Change in Handgrip Strength (dominant and non-dominant), kg
Time frame: Baseline to immediately post-session
Change in Heart Rate, Change in Respiratory Rate, Change in Oxygen Saturation, Change in Systolic and Diastolic Blood Pressure, Change in Perceived Exertion
Time frame: Baseline to immediately post-session
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 18 Feb 2026.
- Results publication: PubMed 32851483Tanriverdi A, Kahraman BO, Ozsoy I, Ozpelit E, Savci S. Acute effects of inspiratory muscle training at different intensities in healthy young people. Ir J Med Sci. 2021 May;190(2):577-585. doi: 10.1007/s11845-020-02353-w. Epub 2020 Aug 26.
- Results publication: PubMed 23812534Rodrigues F, Araujo AA, Mostarda CT, Ferreira J, de Barros Silva MC, Nascimento AM, Lira FS, De Angelis K, Irigoyen MC, Rodrigues B. Autonomic changes in young smokers: acute effects of inspiratory exercise. Clin Auton Res. 2013 Aug;23(4):201-7. doi: 10.1007/s10286-013-0202-1. Epub 2013 Jun 28.
- Individual participant dataSharing planned: Undecided. The team is evaluating repository options and consent language for de-identified IPD sharing.
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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.
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 (30% MIP) and Inspiratory Muscle Training (60% MIP) in people with Smokers, run by FATMA DİLARA AKAR ÇAMYAR 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 3 inclusion and 7 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 18 Feb 2026. 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. 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 Maximal Inspiratory Pressure (MIP), cmH₂O and % predicted (time frame: Baseline (pre-session) to immediately post-session (within ~5 minutes after IMT)). 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 NCT07200895, which also lists 2 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 18 Feb 2026.