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

Condition(s) studied

Investigational drug(s) / intervention(s)

inspiratory muscle training: 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: 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Pulmonary function test — 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) \[MEF50/MIF50 in liters\].
• Respiratory muscle strength (PImax/PEmax) — 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.
• Forced oscillation technique (FOT) — 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.
• Laboratory tests — 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.

Trial sites (1)

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