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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammation; Obesity & Overweight; Ventilation Disorders
• Intervention / Treatment: Device: inspiratory muscle training; Device: placebo-IMT

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paulina Okrzymowska, phD; Phone Number: +48 71 347 3520; Email: paulina.okrzymowska@awf.wroc.pl

Study Locations

• Poland
  • Dolny Śląsk
    • Wroclaw, Dolny Śląsk, Poland, 51-612
      • Recruiting
      • Wroclaw University of Health and Sport Sciences
      • Contact: Phone Number: +48 71 347 3520; Email: paulina.okrzymowska@awf.wroc.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IMT Group	Device: 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 Comparator: placebo-IMT	Device: 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.
No Intervention: Control group; No Intervention: IMT Control Group - IMT Control Group - participants who will not complete the IMT cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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].	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.	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.	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.	Baseline and after 6 weeks (post-intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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].	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.	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.	Baseline and after 6 weeks (post-intervention)

Collaborators and Investigators

• Sponsor: Wroclaw University of Health and Sport Sciences
• Investigators: Principal Investigator: Dariusz Kałka, prof., Wroclaw University of Health and Sport Sciences; Study Director: Krystyna Rożek-Piechura, prof., Wroclaw University of Health and Sport Sciences; Principal Investigator: Paulina Okrzymowska, Wroclaw University of Health and Sport Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: November 26, 2025
• First Submitted That Met QC Criteria: December 14, 2025
• First Posted (Actual): December 29, 2025

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 12, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: obesity; spirometry; inflammation; inspiratory muscle training; forced oscillation technique; ventilation disorders
• Additional Relevant MeSH Terms: Pathologic Processes; Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Inflammation
• Other Study ID Numbers: 00913

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No