Effects of Inspiratory Muscle Training With Diaphragmatic Ac-tivation on Respiratory, Cardiovascular, and Psychosocial Pa-rameters in Female Athletes: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Maximal Inspiratory Pressure (MIP)
研究概览
简要总结
The aim of this clinical study is to determine whether diaphragm-focused IMT training has an effect on respiratory, psychosocial, and cardiovascular parameters in healthy women. The primary questions the study aims to address are as follows:
Does Diaphragm-Focused Respiratory Muscle Training (IMT) positively affect participants' psychosocial parameters (attention, anxiety, motivation)? Does Diaphragm-Focused Respiratory Muscle Training (IMT) improve participants' cardiovascular and respiratory parameters? To assess the effects of Diaphragm-Focused IMT on psychosocial, respiratory, and cardiovascular outcomes, participants were administered IMT at 0% of their MIP level, and the results were compared to a SHAM (placebo) group.
Participants:
They were divided into 3 groups (experimental, SHAM, control); The experimental and SHAM groups received one week of diaphragm muscle activation training before the experimental intervention began, followed by IMT administered five days a week for four weeks. The control group did not participate in any training and only took part in measurements.
All measurements were conducted in two phases-pre-test and post-test-under controlled laboratory conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 23 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •She has been actively participating in sports for 5 years
- •Between the ages of 18 and 23
排除标准
- •A history of any cardiopulmonary disease and having any respiratory condition (such as COPD) or psychological disorder in daily life
研究组 & 干预措施
Experimental
干预措施: Inspiratory Muscle Training(PowerBreathe) (Device)
SHAM
干预措施: Inspiratory Muscle Training (%0 MIP) (Device)
Control
结局指标
主要结局
Maximal Inspiratory Pressure (MIP)
时间窗: Baseline( 1 week) and immediately post-intervention( after 4 week)
Maximal Inspiratory Pressure (MIP) will be assessed as an index of inspiratory muscle strength using a calibrated respiratory pressure device in accordance with established guidelines. Measurements will be performed with participants in a seated position while wearing a nose clip. Participants will be instructed to perform maximal inspiratory efforts against an occluded airway starting from residual volume. At least two to three acceptable and reproducible maneuvers (variation ≤10%) will be obtained, and the highest value will be recorded for analysis. Metrics: Centimeters of water pressure (cmH₂O)
Maximal Expiratory Pressure (MEP)
时间窗: Baseline (1 week) and immediately post-intervention( after 4 week)
Maximal Expiratory Pressure (MEP) will be assessed as an index of expiratory muscle strength using the same calibrated respiratory pressure device under standardized conditions. Participants will perform maximal expiratory efforts against an occluded airway starting from total lung capacity. At least two to three acceptable and reproducible maneuvers (variation ≤10%) will be recorded, and the highest value will be used for analysis. Metrics: Centimeters of water pressure(cmH₂O)
Forced Vital Capacity (FVC)
时间窗: Baseline (1 week) and immediately post-intervention(after 4 week)
Forced Vital Capacity (FVC) will be measured using spirometry according to ATS standards under standardized resting conditions. The highest value from at least two acceptable maneuvers will be recorded. FVC represents the maximal volume of air exhaled forcefully after a full inspiration. Metrics: Liters(L)
Forced Expiratory Volume in 1 Second (FEV₁)
时间窗: Baseline (1 week) and immediately post-intervention (after 4 week)
Forced Expiratory Volume in 1 Second (FEV₁) will be assessed using spirometry in accordance with American Thoracic Society (ATS) standards. Measurements will be performed with participants in a seated position after reaching resting heart rate and oxygen saturation levels. Each participant will complete at least two acceptable maneuvers, and the highest value meeting ATS acceptability criteria will be recorded. FEV₁ reflects the volume of air exhaled during the first second of a forced expiratory maneuver. Metrics: Liters (L)
Concentration Performance (CP) Score (d2 Attention Test)
时间窗: Baseline (1 week) and immediately post-intervention( after 4 week)
Concentration Performance (CP) score will be assessed using the d2 Test of Attention as an index of selective attention and processing accuracy. The test consists of identifying and marking target stimuli under time pressure across multiple lines. CP is calculated as the total number of correctly marked target items minus commission errors (incorrectly marked items). The test will be administered under standardized conditions in a quiet environment, and scoring will follow established guidelines. Metrics: Score
State Anxiety Score (STAI Form I)
时间窗: Baseline( 1 week) and immediately post-intervention( after 4 week)
State anxiety will be assessed using the State-Trait Anxiety Inventory (STAI Form I), a validated self-report questionnaire designed to measure transient anxiety levels at a given moment. The instrument consists of 20 items rated on a 4-point Likert scale. Total scores range from 20 to 80, with higher scores indicating greater levels of state anxiety. The questionnaire will be administered under standardized conditions in a quiet environment, and scoring will be conducted standardized guidelines. Metrics: Score (range: 20-80)
Trait Anxiety Score (STAI Form II)
时间窗: Baseline (1 week) and immediately post-intervention (after 4 week)
Trait anxiety will be assessed using the State-Trait Anxiety Inventory (STAI Form II), which evaluates relatively stable individual differences in anxiety proneness. The scale consists of 20 items rated on a 4-point Likert scale. Total scores range from 20 to 80, with higher scores indicating higher trait anxiety. The questionnaire will be administered and scored standardized procedures. Metrics: Score ( range: 20-80)
Exercise Motivation Attitude Scale (Score)
时间窗: Baseline (1 week) and immediately post-intervention (after 4 week)
Participants' motivation toward exercise is measured using the Exercise Motivation Attitude Scale. The scale consists of 20 items and uses a 7-point Likert-type rating scale. The total score ranges from 20 to 140, with higher scores indicating higher levels of motivation. Metrics: Score (range: 20-140)
Heart Rate (HR)
时间窗: Baseline (1 week) and immediately post-intervention (after 4 week)
Heart rate (HR) will be measured using a validated pulse oximeter under standardized resting conditions. Measurements will be obtained with participants in a seated position after reaching physiological rest. The average of two consecutive readings will be recorded. Heart rate reflects the number of cardiac beats per minute Metrics: Beats per minute (bpm)
次要结局
- Peak Expiratory Flow (PEF)(Baseline(1 week) and immediately post-intervention(after 4 week))
- Forced Expiratory Flow 25-75% (FEF25-75%)(Baseline(1 week) and immediately post-intervention( after 4 week))
- Total Number of Items Processed (TN) (d2 attention test)(Baseline( 1 week) and immediately post- intervention (after 4 week))
- Total Number of Items Processed Minus Errors (TN-E)(Baseline (1 week) and immediately post-intervention (after 4 week))
- Oxygen Saturation (SpO₂)(Baseline (1 week) and immediately post-intervention ( after 4 week))
研究者
Mete Berk Demiryol
Principal Investigator
University of Gaziantep
