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

5 augustus 2026 bijgewerkt door: Ceyhun Topcuoglu, Hacettepe University

Comparison of High- and Moderate-Intensity Inspiratory Muscle Training on Diaphragm Ultrasound Parameters, Cognition, and Mental Health in Young Adults With Low Muscle Mass Index: A Randomized Controlled Trial

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Low skeletal muscle mass during young adulthood has become an increasingly recognized public health concern because it is associated with reduced physical performance, impaired metabolic health, and an increased risk of developing sarcopenia later in life. In addition to peripheral skeletal muscles, reduced muscle mass may affect diaphragm structure and function, potentially contributing to impaired respiratory mechanics as well as alterations in cognition, sleep, psychological well-being, and health-related quality of life. Although inspiratory muscle training (IMT) has been widely used to improve inspiratory muscle performance, the influence of different IMT intensities on diaphragm morphology and multidimensional health outcomes has not been fully established.

This randomized, sham-controlled clinical trial is designed 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. The primary objective is to determine whether training intensity influences changes in diaphragm structure and function assessed by ultrasonography. Secondary objectives are to evaluate the effects of different IMT intensities on cognitive function, sleep quality, daytime sleepiness, insomnia severity, anxiety, and health-related quality of life.

Participants aged 18-25 years with low skeletal muscle mass will be randomly assigned to one of three parallel groups using age- and sex-stratified block randomization. Participants allocated to the HI-IMT group will perform inspiratory muscle training at approximately 80% of maximal inspiratory pressure (MIP), whereas participants in the MI-IMT group will train at approximately 50-60% of MIP. Participants in the sham group will perform inspiratory muscle training using minimal resistance (approximately 15% of MIP). The intervention will last 6 weeks, with five training sessions per week. One session each week will be supervised by a physiotherapist, and the remaining sessions will be completed at home with regular monitoring.

Outcome assessments will be performed before and after the intervention. Primary outcome measures will include diaphragm thickness, diaphragm thickening fraction, and diaphragm excursion assessed using ultrasonography. Secondary outcome measures will include body composition, 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 the Generalized Anxiety Disorder-7 (GAD-7), and health-related quality of life assessed using the Short Form-36 Health Survey (SF-36).

The study is designed to evaluate whether different inspiratory muscle training intensities are associated with differences in diaphragm morphology and function, cognitive function, sleep, anxiety, and health-related quality of life in young adults with low skeletal muscle mass.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

69

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Turkije (Türkiye)
      • Tunceli, Turkije (Türkiye)
        • Munzur University Faculty of Health Sciences

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Ja

Beschrijving

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: High-Intensity Inspiratory Muscle Training (HI-IMT) Group
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.
Ander: High-Intensity IMT
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.
Experimenteel: Moderate-Intensity Inspiratory Muscle Training (MI-IMT) Group
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.
Ander: Moderate-Intensity IMT
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.
Sham-vergelijker: Sham Training Group
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.
Ander: Sham
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Diaphragm Thickness Measured by Ultrasonography
Tijdsspanne: Baseline and Week 6
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
Tijdsspanne: Baseline and Week 6
Diaphragm thickening fraction measured by ultrasonography. The outcome is the change from baseline to Week 6.
Baseline and Week 6
Change in Diaphragm Excursion
Tijdsspanne: Baseline and Week 6
Diaphragm excursion (mobility) measured by ultrasonography. The outcome is the change from baseline to Week 6.
Baseline and Week 6

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Montreal Cognitive Assessment (MoCA) Score
Tijdsspanne: Baseline and Week 6
Cognitive function assessed using the Montreal Cognitive Assessment (MoCA). The Montreal Cognitive Assessment is a 30-point cognitive screening instrument with total scores ranging from 0 to 30. Higher scores indicate better cognitive function. The outcome measure is the change in total score from baseline to Week 6.
Baseline and Week 6
Change in Pittsburgh Sleep Quality Index (PSQI) Score
Tijdsspanne: Baseline and Week 6
Sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI). The Pittsburgh Sleep Quality Index is a 21-point questionnaire with total scores ranging from 0 to 21. Higher scores indicate poorer sleep quality. The outcome measure is the change in total score from baseline to Week 6.
Baseline and Week 6
Change in Epworth Sleepiness Scale (ESS) Score
Tijdsspanne: Baseline and Week 6
Daytime sleepiness assessed using the Epworth Sleepiness Scale (ESS). The Epworth Sleepiness Scale is a 24-point questionnaire with total scores ranging from 0 to 24. Higher scores indicate greater daytime sleepiness. The outcome measure is the change in total score from baseline to Week 6.
Baseline and Week 6
Change in Insomnia Severity Index (ISI) Score
Tijdsspanne: Baseline and Week 6
Insomnia severity assessed using the Insomnia Severity Index (ISI). The Insomnia Severity Index is a 28-point questionnaire with total scores ranging from 0 to 28. Higher scores indicate greater insomnia severity. The outcome measure is the change in total score from baseline to Week 6.
Baseline and Week 6
Change in State Anxiety Inventory (STAI-State) Score
Tijdsspanne: Baseline and Week 6
State anxiety assessed using the State-Trait Anxiety Inventory-State (STAI-State). The State-Trait Anxiety Inventory-State is a 20-item questionnaire with total scores ranging from 20 to 80. Higher scores indicate greater state anxiety. The outcome measure is the change in total score from baseline to Week 6.
Baseline and Week 6
Change in Trait Anxiety Inventory (STAI-Trait) Score
Tijdsspanne: Baseline and Week 6
Trait anxiety assessed using the State-Trait Anxiety Inventory-Trait (STAI-Trait). The State-Trait Anxiety Inventory-Trait is a 20-item questionnaire with total scores ranging from 20 to 80. Higher scores indicate greater trait anxiety. The outcome measure is the change in total score from baseline to Week 6.
Baseline and Week 6
Change in Generalized Anxiety Disorder-7 (GAD-7) Score
Tijdsspanne: Baseline and Week 6
Generalized anxiety symptoms assessed using the Generalized Anxiety Disorder 7-item Scale (GAD-7). The Generalized Anxiety Disorder 7-item Scale is a 7-item questionnaire with total scores ranging from 0 to 21. Higher scores indicate greater anxiety symptom severity. The outcome measure is the change in total score from baseline to Week 6.
Baseline and Week 6
Change in Short Form-36 (SF-36) Total Score
Tijdsspanne: Baseline and Week 6
Health-related quality of life assessed using the 36-Item Short Form Health Survey (SF-36). The 36-Item Short Form Health Survey generates a total score ranging from 0 to 100, with higher scores indicating better health-related quality of life. The outcome measure is the change in total score from baseline to Week 6.
Baseline and Week 6

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hacettepe University

Publicaties en nuttige links

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Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

5 januari 2026

Primaire voltooiing (Werkelijk)

21 mei 2026

Studie voltooiing (Werkelijk)

23 juni 2026

Studieregistratiedata

Eerst ingediend

2 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

5 augustus 2026

Eerst geplaatst (Werkelijk)

11 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

11 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

5 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2025/16-2

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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