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NCT Number: NCT07307417

Assessment of Respiratory Dysfunction in Obesity and the Use of IMT.

The aim of the project will be to assess the functional condition of the respiratory tract and inflammation resulting from obesity, as well as the possibility of using inspiratory muscle training as a factor reducing the occurrence of dysfunction in the respiratory system.

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Key information

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wroclaw University of Health and Sport Sciences

Wroclaw, Dolny Śląsk, 51-612, Poland

Location status: Recruiting

Location contact

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosed obesity, BMI equal to or greater than 30 kg/m2
  • age between 30 and 60 (women and men),
  • consent of the subject.

Exclusion criteria

  • respiratory diseases requiring pharmacological treatment,
  • acute illness that may affect the training programme: e.g. infection, renal failure,
  • mental impairment preventing cooperation,
  • mental disorders preventing contact and cooperation with the patient,
  • pacemaker,
  • pregnancy
  • implanted electronic
  • medical implants
  • epilepsy
  • metal implants.

Treatment and study plan

Inspiratory muscle training

Device

The IMT experimental group will undergo training with a load of 30% of PImax, assessed in the first inspiratory muscle strength test. Training will be conducted twice a day, with 30 breaths in each training session. From the second week onwards, the training load will be increased by 10% each week. The maximum load will be 60% of PImax. The intervention will last 6 weeks and will be performed daily.

placebo-IMT

Device

The control group will perform simulated inspiratory muscle training with a constant load of 15% PImax. Training will take place 7 times a week, 60 breaths once a day. The intervention will last 6 weeks and will be performed daily.

Primary outcomes

  1. Pulmonary function test

    Time frame: Baseline and after 6 weeks (post-intervention)

    Respiratory function testing (spirometry) will be performed in accordance with the guidelines of the American Thoracic Society and the European Respiratory Society. The respiratory function test will include the following parameters: forced vital capacity (FVC)[FVC in liters], forced expiratory volume in one second (FEV1) [FEV1 in liters], peak expiratory flow (PEF)[PEF in liters/second], vital capacity (VC) [VC in liters], maximum expiratory flow at 25%, 50% and 75% FVC (MEF 25-75%) [MEF 25-75% in liters], maximal inspiratory flow (MIF50) [MIF in liters], maximal expiratory Flow at 50% of vital capacity (MEF50) and maximal inspiratory flow at 50% of vital capacity (MIF50) (MEF50/MIF50) [MEF50/MIF50 in liters].

  2. Respiratory muscle strength (PImax/PEmax)

    Time frame: Baseline and after 6 weeks (post-intervention)

    Respiratory Muscle Strength (PImax/PEmax) by assessing maximum inspiratory pressure (PImax in kilopascal,kPa) and expiratory pressure (PEmax in kilopascal,kPa).

    This measurement is to evaluate the potential effect of the intervention on the strength of inspiratory and expiratory muscles, particularly the potential to improve respiratory muscle performance and enhance overall ventilatory capacity in individuals with reduced respiratory muscle strength.

  3. Forced oscillation technique (FOT)

    Time frame: Baseline and after 6 weeks (post-intervention)

    respiratory mechanics parameter: resistance (Rrs)[Rrs in kPa·s·L-¹], reactance (Xrs) [Xrs in kPa·s·L-¹], resonant Frequency (Fres): The frequency where Xrs = 0 (reactance cancels out).

    This measurement is to evaluate the potential effect of the intervention on airway resistance and reactance, particularly the potential to improve lung mechanics and detect subtle changes in airway function in individuals with impaired or fluctuating respiratory function.

  4. Laboratory tests

    Time frame: Baseline and after 6 weeks (post-intervention)

    inflammatory cytokine profile and CRP (IL-1β, IL-6, IL-8, IL-10, IL-12, TNF-α, CRP), lipid profile.

    Systemic inflammation parameter and lipid profile, this measurement is to evaluate the potential effect of the intervention on inflammatory status, particularly the potential to modify circulating cytokine levels and acute-phase response markers. Laboratory analyses will be performed by qualified diagnostic personnel. Blood samples will be collected into plasma separator tubes (containing lithium-heparin gel), centrifuged, and analyzed. The following parameters will be used for the assessment: interlukin-1β, interlukin-6, interlukin-8, interlukin-10, interlukin-12, tumor necrosis factor-alpha (TNF-α), C-reactive protein (CRP), lipid profile (HDL, LDL, TG). The study will be performed once in all study participants and a second time in those undergoing inspiratory muscle training to assess changes in systemic inflammation associated with the intervention.

Secondary outcomes

  1. Body Composition (Bioelectrical Impedance Analysis, BIA)

    Time frame: Baseline and after 6 weeks (post-intervention)

    Body composition parameter - this measurement assesses: Total Body Water (TBW) [TBW in Liters], Fat-Free Mass (FFM) [FFM in Kilograms], Fat Mass (FM) [FM in Kilograms], Body Fat Percentage (%) in Percentage (%), Height (H) [H in Centimeters], Weight (BW) [BW in Kilograms].

  2. World Health Organization - Quality of Life - BREF (WHOQOL-BREF)

    Time frame: Baseline and after 6 weeks (post-intervention)

    Quality of life parameter - WHOQOL-BREF. This measurement aims to assess participants' perceptions of their quality of life in the physical, mental, social, and environmental areas, in particular the potential to improve the overall well-being and daily functioning of individuals undergoing intervention. The numerical score in each domain reflects individual perceptions of quality of life. Scores are determined on a five-point scale, with a possible range of 4 to 20 points in each domain. The higher the score, the higher the quality of life.

  3. International Physical Activity Questionnaire - short version (IPAQ - short version)

    Time frame: Baseline and after 6 weeks (post-intervention)

    Physical activity parameter. This measure aims to assess participants' physical activity levels, specifically the potential to increase overall activity, reduce sedentary behavior, and monitor changes in daily movement patterns in individuals undergoing the intervention. In IPAQ-SF, physical activity level is measured in MET units (MET - Metabolic Equivalent of Task) [MET - min/week]. High physical activity level is >3000 MET-min/week, moderate is 600-3000 MET-min/week, and low is <600 MET-min/week.

Study contacts

Contact information is provided by the study sponsor or research team.

Paulina Okrzymowska, phD

CONTACT

[email protected]

+48 71 347 3520

Sponsors and collaborators

Lead sponsor

Wroclaw University of Health and Sport Sciences

Other

Registry information

Official study title

Functional Respiratory Tract Dysfunctions in Individuals With Obesity Undergoing Experimental Inspiratory Muscle Training.

Acronym: IMT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 29, 2025
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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