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Completed

NCT Number: NCT07200895

Acute IMT Intensity Effects in Male Smokers

Acute IMT Intensity Effects in Male Smokers

Completed

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Key information

Conditions

Age range

18 year–25 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Biruni University

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male, 18-25 years of age.
  • Current cigarette smoker for ≥1 year (regular use).
  • No known acute or chronic medical condition.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in Maximal Expiratory Pressure (MEP), cmH₂O and % predicted

    Time frame: Baseline to immediately post-session

    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.

  2. Change in Handgrip Strength (dominant and non-dominant), kg

    Time frame: Baseline to immediately post-session

    Assessed with a calibrated hand dynamometer (e.g., Jamar). Best of three trials for each hand recorded. Endpoint is post-pre change (kg).

  3. 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

    • 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).

Sponsors and collaborators

Lead sponsor

FATMA DİLARA AKAR ÇAMYAR

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Oct 1, 2025
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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