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

5 sierpnia 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

69

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły

Akceptuje zdrowych ochotników

Tak

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Inny: 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.
Eksperymentalny: 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.
Inny: 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.
Pozorny komparator: 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.
Inny: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in Diaphragm Thickness Measured by Ultrasonography
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Baseline and Week 6
Diaphragm excursion (mobility) measured by ultrasonography. The outcome is the change from baseline to Week 6.
Baseline and Week 6

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in Montreal Cognitive Assessment (MoCA) Score
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Hacettepe University

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

5 stycznia 2026

Zakończenie podstawowe (Rzeczywisty)

21 maja 2026

Ukończenie studiów (Rzeczywisty)

23 czerwca 2026

Daty rejestracji na studia

Pierwszy przesłany

2 sierpnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

5 sierpnia 2026

Pierwszy wysłany (Rzeczywisty)

11 sierpnia 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

11 sierpnia 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

5 sierpnia 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 2025/16-2

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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