Acute IMT Intensity Effects in Male Smokers

FATMA DİLARA AKAR ÇAMYAR

Status: Not yet enrolling

Conditions: Smokers

Treatments: Device: Inspiratory Muscle Training (60% MIP); Device: Inspiratory Muscle Training (30% MIP)

Study type: Interventional

Funder types: Other

Identifiers

NCT07200895

BiruniU-IMT2025

Details and patient eligibility

About

Acute IMT Intensity Effects in Male Smokers

Full 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.

Enrollment: 34 estimated patients

Sex: Male

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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34 participants in 2 patient groups

30% MIP IMT

Experimental group

Description:

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.

Treatment:

Device: Inspiratory Muscle Training (30% MIP)

60% MIP IMT

Experimental group

Description:

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.

Treatment:

Device: Inspiratory Muscle Training (60% MIP)