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

NCT07307417 | Recruiting

• 1 other identifier: 00913
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inflammation; Obesity & Overweight; Ventilation Disorders

Keywords

inspiratory muscle training; obesity; ventilation disorders; inflammation; forced oscillation technique; spirometry

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Body Composition (Bioelectrical Impedance Analysis, BIA)

  Baseline and after 6 weeks (post-intervention)

• World Health Organization - Quality of Life - BREF (WHOQOL-BREF)

  Baseline and after 6 weeks (post-intervention)

• International Physical Activity Questionnaire - short version (IPAQ - short version)

  Baseline and after 6 weeks (post-intervention)

Study Arms (3)

IMT Group

EXPERIMENTAL

Device: inspiratory muscle training

placebo-IMT

PLACEBO COMPARATOR

Device: placebo-IMT

Control group

NO INTERVENTION

No Intervention: IMT Control Group - IMT Control Group - participants who will not complete the IMT cycle.

Interventions

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.

placebo-IMT

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.

IMT Group

Eligibility Criteria

• Age: 30 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wroclaw University of Health and Sport Sciences: lead

Study Sites (1)

Wroclaw University of Health and Sport Sciences

Wroclaw, Dolny Śląsk, 51-612, Poland

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight; Inflammation

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Dariusz Kałka, prof.

  Wroclaw University of Health and Sport Sciences

  PRINCIPAL INVESTIGATOR

• Krystyna Rożek-Piechura, prof.

  Wroclaw University of Health and Sport Sciences

  STUDY DIRECTOR

• Paulina Okrzymowska

  Wroclaw University of Health and Sport Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paulina Okrzymowska, phD

CONTACT

+48 71 347 3520; paulina.okrzymowska@awf.wroc.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 29, 2025
• Study Start: March 25, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)