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临床试验/NCT07200895
NCT07200895已完成不适用

Investigation of the Acute Effects of Inspiratory Muscle Training at Different Intensities on Vital Signs and Peripheral and Respiratory Muscle Strength in Male Smokers

FATMA DİLARA AKAR ÇAMYAR1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2025年10月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
34
试验地点
1
主要终点
Change in Maximal Inspiratory Pressure (MIP), cmH₂O and % predicted

研究概览

简要总结

Acute IMT Intensity Effects in Male Smokers

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
Male
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Inspiratory Muscle Training (30% MIP) (Device)

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.

干预措施: Inspiratory Muscle Training (60% MIP) (Device)

结局指标

主要结局

Change in Maximal Inspiratory Pressure (MIP), cmH₂O and % predicted

时间窗: 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.

次要结局

  • Change in Maximal Expiratory Pressure (MEP), cmH₂O and % predicted(Baseline to immediately post-session)
  • Change in Handgrip Strength (dominant and non-dominant), kg(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(Baseline to immediately post-session)

研究者

发起方
FATMA DİLARA AKAR ÇAMYAR
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

FATMA DİLARA AKAR ÇAMYAR

Principal Investigator

Biruni University

研究点 (1)

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