An interventional study of inspiratory muscle training and placebo-IMT in Obesity & Overweight, Inflammation and Ventilation Disorders, sponsored by Wroclaw University of Health and Sport Sciences. Recruiting at 1 site in Poland. Open to participants aged 30 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-04-14.
Sponsored by Wroclaw University of Health and Sport Sciences · Not applicable, Interventional, and Basic science
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's planned enrollment of 40 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Wroclaw University of Health and Sport Sciences is the lead sponsor of 44 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: inspiratory muscle training
Device: placebo-IMT
No Intervention: IMT Control Group - IMT Control Group - participants who will not complete the IMT cycle.
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.
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.
Pulmonary function test
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) \[MEF50/MIF50 in liters\].
Time frame: Baseline and after 6 weeks (post-intervention)
Respiratory muscle strength (PImax/PEmax)
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.
Time frame: Baseline and after 6 weeks (post-intervention)
Forced oscillation technique (FOT)
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.
Time frame: Baseline and after 6 weeks (post-intervention)
Laboratory tests
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.
Time frame: Baseline and after 6 weeks (post-intervention)
Body Composition (Bioelectrical Impedance Analysis, BIA)
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) \[BW in Kilograms\].
Time frame: Baseline and after 6 weeks (post-intervention)
World Health Organization - Quality of Life - BREF (WHOQOL-BREF)
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.
Time frame: Baseline and after 6 weeks (post-intervention)
International Physical Activity Questionnaire - short version (IPAQ - short version)
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.
Time frame: Baseline and after 6 weeks (post-intervention)
Plan to share: No
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Wroclaw University of Health and Sport Sciences