Acute IMT Intensity Effects in Male Smokers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2026-01-31

Brief Summary

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Acute IMT Intensity Effects in Male Smokers

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Detailed Description

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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

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Smokers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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30% MIP IMT

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.

Group Type EXPERIMENTAL

Inspiratory Muscle Training (30% MIP)

Intervention Type 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.

60% MIP IMT

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.

Group Type EXPERIMENTAL

Inspiratory Muscle Training (60% MIP)

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes