High- and Moderate-Intensity Inspiratory Muscle Training on Diaphragm Ultrasound Parameters, Cognition, and Mental Health

NCT07757139 | Completed

• 1 other identifier: 2025/16-2
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

Low skeletal muscle mass during young adulthood may impair diaphragm function, cognition, sleep, and psychological well-being. Inspiratory muscle training (IMT) has been shown to improve respiratory muscle performance; however, it remains unclear whether different IMT intensities produce differential effects on diaphragm morphology and function, cognition, sleep, anxiety, and health-related quality of life. The purpose of this randomized controlled trial is to compare the effects of high-intensity inspiratory muscle training (HI-IMT), moderate-intensity inspiratory muscle training (MI-IMT), and sham inspiratory muscle training in young adults with low skeletal muscle mass. A total of 69 participants with low skeletal muscle mass will be randomly assigned to one of three groups: (1) HI-IMT, (2) MI-IMT, or (3) sham IMT. Participants will complete a supervised 6-week intervention consisting of five training sessions per week. Participants allocated to the HI-IMT group will perform inspiratory muscle training at approximately 80% of maximal inspiratory pressure (MIP), whereas those in the MI-IMT group will train at approximately 50-60% of MIP. The sham group will perform low-intensity inspiratory muscle training at approximately 15% of MIP. Training intensity will be adjusted throughout the intervention according to repeated MIP assessments. Outcome assessments will be performed before and after the intervention. Primary outcomes will include diaphragm thickness, diaphragm thickening fraction, and diaphragm excursion assessed using ultrasonography. Secondary outcomes will include cognitive function assessed using the Montreal Cognitive Assessment (MoCA), sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI), daytime sleepiness assessed using the Epworth Sleepiness Scale (ESS), insomnia severity assessed using the Insomnia Severity Index (ISI), anxiety assessed using the State-Trait Anxiety Inventory (STAI), and health-related quality of life assessed using the Short Form-36 Health Survey (SF-36). The primary hypothesis is that both HI-IMT and MI-IMT will improve diaphragm morphology and function, cognition, sleep, anxiety, and health-related quality of life compared with sham IMT. It is further hypothesized that HI-IMT will produce greater improvements than MI-IMT because of the higher inspiratory training intensity.

Conditions

Low Skeletal Muscle Mas

Keywords

inspiratory muscle training; diaphragm ultrasonography; low skeletal muscle mass; cognitive function; anxiety; sleep quality

Outcome Measures

Primary Outcomes (3)

• Change in Diaphragm Thickness Measured by Ultrasonography

  Diaphragm thickness will be assessed using B-mode ultrasonography at functional residual capacity (FRC) and total lung capacity (TLC). The primary outcome is the change in diaphragm thickness from baseline to completion of the 6-week intervention. Measurements will be performed by a blinded radiologist using a standardized ultrasound protocol.

  Baseline and Week 6

• Change in Diaphragm Thickening Fraction

  Diaphragm thickening fraction measured by ultrasonography. The outcome is the change from baseline to Week 6.

  Baseline and Week 6

• Change in Diaphragm Excursion

  Diaphragm excursion (mobility) measured by ultrasonography. The outcome is the change from baseline to Week 6.

  Baseline and Week 6

Secondary Outcomes (8)

• Change in Montreal Cognitive Assessment (MoCA) Score

  Baseline and Week 6

• Change in Pittsburgh Sleep Quality Index (PSQI) Score

  Baseline and Week 6

• Change in Epworth Sleepiness Scale (ESS) Score

  Baseline and Week 6

• Change in Insomnia Severity Index (ISI) Score

  Baseline and Week 6

• Change in State Anxiety Inventory (STAI-State) Score

  Baseline and Week 6

Study Arms (3)

High-Intensity Inspiratory Muscle Training (HI-IMT) Group

EXPERIMENTAL

Participants assigned to this group completed a 6-week high-intensity inspiratory muscle training program using a POWERbreathe Classic Light Resistance device. Training was performed five days per week, including one supervised session and four home-based sessions. The initial training load was set at approximately 80% of the predicted maximal inspiratory pressure (MIP) and was progressively adjusted weekly to maintain the target training intensity.

Other: High-Intensity IMT

Moderate-Intensity Inspiratory Muscle Training (MI-IMT) Group

EXPERIMENTAL

Participants assigned to this group completed a 6-week moderate-intensity inspiratory muscle training program using a POWERbreathe Classic Light Resistance device. Training was performed five days per week, including one supervised session and four home-based sessions. The initial training load was set at 50-60% of the predicted maximal inspiratory pressure (MIP) and was progressively adjusted weekly to maintain the prescribed training intensity.

Other: Moderate-Intensity IMT

Sham Training Group

SHAM COMPARATOR

Participants assigned to this group completed a 6-week sham inspiratory muscle training program using the same device and training schedule. The resistance was maintained at 15% of maximal inspiratory pressure (MIP) throughout the intervention to provide minimal inspiratory loading without an intended training effect.

Other: Sham

Interventions

High-Intensity IMT OTHER

Participants performed a 6-week high-intensity inspiratory muscle training program using a threshold-loading inspiratory muscle trainer (POWERbreathe Classic Light Resistance). Training was conducted five days per week, consisting of one supervised session and four home-based sessions. The initial training intensity was set at approximately 80% of the predicted maximal inspiratory pressure (MIP) and was progressively adjusted weekly to maintain the target training intensity according to perceived exertion.

High-Intensity Inspiratory Muscle Training (HI-IMT) Group

Moderate-Intensity IMT OTHER

Participants performed a 6-week moderate-intensity inspiratory muscle training program using a threshold-loading inspiratory muscle trainer (POWERbreathe Classic Light Resistance). Training was conducted five days per week, consisting of one supervised session and four home-based sessions. The initial training intensity was set at 50-60% of the predicted maximal inspiratory pressure (MIP) and was progressively adjusted weekly to maintain the prescribed training intensity.

Moderate-Intensity Inspiratory Muscle Training (MI-IMT) Group

Sham OTHER

Participants completed a 6-week sham inspiratory muscle training program using the same threshold-loading inspiratory muscle trainer. The intervention followed the same schedule as the active groups (five sessions per week, including one supervised and four home-based sessions), while the resistance was maintained at 15% of maximal inspiratory pressure throughout the study to provide minimal inspiratory loading without an intended training effect.

Sham Training Group

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Young adults aged 18 to 25 years.
• Low skeletal muscle mass defined as a skeletal muscle mass index (SMI) \< 8.87 kg/m² for men and \< 6.42 kg/m² for women.
• Clinically stable and able to safely participate in inspiratory muscle training.
• Willing and able to provide written informed consent.
• Able to comply with the study procedures and complete all assessments.

You may not qualify if:

• Presence of cardiovascular, neurological, orthopedic, psychiatric, respiratory, or other systemic diseases that could influence study outcomes.
• History of surgery that could affect participation or outcome assessments.
• Cognitive, psychological, or mental conditions that could interfere with participation or completion of the assessments.
• Inability or unwillingness to complete the intervention protocol or follow-up assessments.
• Any contraindication to inspiratory muscle training as determined by the investigators.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Munzur University Faculty of Health Sciences

Tunceli, Turkey (Türkiye)

Location

Related Publications (1)

• Aktan R, Tertemiz KC, Yigit S, Ozalevli S, Ozgen Alpaydin A, Ucan ES. Effects of home-based telerehabilitation-assisted inspiratory muscle training in patients with idiopathic pulmonary fibrosis: A randomized controlled trial. Respirology. 2024 Dec;29(12):1077-1084. doi: 10.1111/resp.14810. Epub 2024 Aug 11.

  PMID: 39129185 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Sleep Initiation and Maintenance Disorders

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

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

Study Record Dates

• First Submitted: August 2, 2026
• First Posted: August 11, 2026
• Study Start: January 5, 2026
• Primary Completion: May 21, 2026
• Study Completion: June 23, 2026
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)