Psychosocial and Cardiopulmonary Outcomes Following Diaphragm-Focused IMT Training in Healthy Women

NCT07553039 | Completed

• 1 other identifier: 532274/17
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthly Volunteers; Women

Outcome Measures

Primary Outcomes (9)

• Maximal Inspiratory Pressure (MIP)

  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)

  Baseline( 1 week) and immediately post-intervention( after 4 week)

• Maximal Expiratory Pressure (MEP)

  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)

  Baseline (1 week) and immediately post-intervention( after 4 week)

• Forced Vital Capacity (FVC)

  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)

  Baseline (1 week) and immediately post-intervention(after 4 week)

• Forced Expiratory Volume in 1 Second (FEV₁)

  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)

  Baseline (1 week) and immediately post-intervention (after 4 week)

• Concentration Performance (CP) Score (d2 Attention Test)

  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

  Baseline (1 week) and immediately post-intervention( after 4 week)

• State Anxiety Score (STAI Form I)

  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)

  Baseline( 1 week) and immediately post-intervention( after 4 week)

• Trait Anxiety Score (STAI Form II)

  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)

  Baseline (1 week) and immediately post-intervention (after 4 week)

• Exercise Motivation Attitude Scale (Score)

  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)

  Baseline (1 week) and immediately post-intervention (after 4 week)

• Heart Rate (HR)

  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)

  Baseline (1 week) and immediately post-intervention (after 4 week)

Secondary Outcomes (5)

• 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)

Study Arms (3)

Experimental

EXPERIMENTAL

Device: Inspiratory Muscle Training(PowerBreathe)

SHAM

SHAM COMPARATOR

Device: Inspiratory Muscle Training (%0 MIP)

Control

NO INTERVENTION

Interventions

Inspiratory Muscle Training(PowerBreathe) DEVICE

IMT was performed five days a week for four weeks in the experimental groups. The experimental group performed resistance breathing exercises at 40% of their individual MIP values using the PowerBreathe (POWERBreathe International Ltd., Southam, UK) respiratory muscle training device. Each session was performed using a standard protocol (30 breaths × 2), consisting of 30 breaths, 1 min of rest, and another 30 breaths. MIP values were remeasured at the beginning of each week, and the training intensity was updated according to individual levels.

Experimental

Inspiratory Muscle Training (%0 MIP) DEVICE

IMT was performed five days a week for four weeks in sham groups. The experimental group performed resistance breathing exercises at 0% of their individual MIP values using the PowerBreathe (POWERBreathe International Ltd., Southam, UK) respiratory muscle training device. Each session was performed using a standard protocol (30 breaths × 2), consisting of 30 breaths, 1 min of rest, and another 30 breaths. Thus, the physiological effect was eliminated, and only procedural control was provided.

SHAM

Eligibility Criteria

• Age: 18 Years - 23 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• She has been actively participating in sports for 5 years
• Between the ages of 18 and 23

You may not qualify if:

• A history of any cardiopulmonary disease and having any respiratory condition (such as COPD) or psychological disorder in daily life

Sponsors & Collaborators

• University of Gaziantep: lead

Study Sites (1)

Gaziantep University, Faculty of Sport Sciences

Gaziantep, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 27, 2026
• Study Start: October 15, 2024
• Primary Completion: November 30, 2024
• Study Completion: December 30, 2024
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

TU (1)