Investigation of Inspiratory Muscle Training Applied at Different Intensities on Intercostal Muscle Oxygenation

NCT07029074 | Recruiting

• 1 other identifier: AhiEvranU529
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, it was aimed to investigate the acute effect of inspiratory muscle training of different intensities on intercostal muscle oxygenation in healthy individuals.

Conditions

Healthy

Keywords

muscle oxygenation; inspiratory muscle training; intercostal muscle

Outcome Measures

Primary Outcomes (2)

• Evaluation of intercostal muscle oxygenation

  Before the inspiratory muscle training sessions, the muscle oxygen saturation (SmO2) of the intercostal muscles in recovery during and after the training session will be measured using a Moxy® monitor (Moxy, Fortiori Design LLC, Minnesota, USA).

  Second, Third and Fourth day

• Evaluation of intercostal muscle total hemoglobin level

  Before the inspiratory muscle training sessions, total hemoglobin level (THb) of the intercostal muscles in recovery during and after the training session will be measured using a Moxy® monitor (Moxy, Fortiori Design LLC, Minnesota, USA).

  Second, Third and Fourth day

Secondary Outcomes (8)

• Evaluation of respiratory muscle strength

  First day

• Evaluation of respiratory muscle endurance

  First day

• Evaluation of pulmonary function (Forced expiratory volume in the first second (FEV1))

  First day

• Evaluation pulmonary function (Forced vital capacity (FVC))

  First day

• Evaluation of pulmonary function (FEV1/FVC)

  First day

Study Arms (3)

Sham inspiratory muscle training (Maximal inspiratory pressure (MIP) 0%)

EXPERIMENTAL

Individuals participating in the study will be randomly assigned sham inspiratory muscle training sessions maximal inspiratory pressure of 0% under the supervision of a specialist physiotherapist for 30 minutes.

Device: Sham inspiratory muscle training (MIP 0%)

MIP 30% inspiratory muscle training

EXPERIMENTAL

Individuals participating in the study will be randomly assigned inspiratory muscle training sessions maximal inspiratory pressure of 30% under the supervision of a specialist physiotherapist for 30 minutes.

Device: MIP 30% inspiratory muscle training

MIP 70% inspiratory muscle training

EXPERIMENTAL

Individuals participating in the study will be randomly assigned inspiratory muscle training sessions maximal inspiratory pressure of 70% under the supervision of a specialist physiotherapist for 30 minutes.

Other: MIP 70% inspiratory muscle training

Interventions

Sham inspiratory muscle training (MIP 0%) DEVICE

POWERbreathe Wellness (POWERbreathe International Ltd.., England, UK) device will be used for inspiratory muscle training.

Sham inspiratory muscle training (Maximal inspiratory pressure (MIP) 0%)

MIP 30% inspiratory muscle training DEVICE

POWERbreathe Wellness (POWERbreathe International Ltd.., England, UK) device will be used for inspiratory muscle training.

MIP 30% inspiratory muscle training

MIP 70% inspiratory muscle training OTHER

POWERbreathe Wellness (POWERbreathe International Ltd.., England, UK) device will be used for inspiratory muscle training.

MIP 70% inspiratory muscle training

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Physically active (doing moderate intensity physical activity for at least 3 days a week for 150 minutes / week)
• Volunteer to participate in the study

You may not qualify if:

• Healthy individuals with any diagnosed chronic or systemic disease,
• Smoke 10 packs x years or more,
• Pneumonia or any acute infection,
• Psychiatric disorder will excluded in the study.

Sponsors & Collaborators

• Kirsehir Ahi Evran Universitesi: lead

Study Sites (1)

Kırşehir Ahi Evran University, Physical Therapy and Rehabilitation Center, Cardiopulmonary Unit

Kırşehir, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Maximal Respiratory Pressures

Intervention Hierarchy (Ancestors)

Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Başak KAVALCI KOL, PhD

CONTACT

+903862802317; basak.kavalci@ahievran.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: This study was designed as a single-blind randomized, placebo-controlled, crossover study.

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 19, 2025
• Study Start: July 23, 2025
• Primary Completion: December 23, 2025
• Study Completion (Estimated): June 23, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)