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

NCT07553039 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-04-27

No results posted yet for this study

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

Interventions

DEVICE

Inspiratory Muscle Training(PowerBreathe)

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.

DEVICE

Inspiratory Muscle Training (%0 MIP)

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.

Sponsors & Collaborators

  • University of Gaziantep

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
23 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-15
Primary Completion
2024-11-30
Completion
2024-12-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07553039 on ClinicalTrials.gov