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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 30 to 60 years
• All sexes
• No healthy volunteers
• Adult

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

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

Conditions

Obesity & Overweight, Inflammation, Ventilation Disorders

Being tested

inspiratory muscle training, placebo-IMT

Keywords

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

Medical subject headings

Obesity, Overweight, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• inspiratory muscle trainingDevice

  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-IMTDevice

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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].

   Measured: Baseline and after 6 weeks (post-intervention)

2. 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.

   Measured: Baseline and after 6 weeks (post-intervention)

3. 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.

   Measured: Baseline and after 6 weeks (post-intervention)

4. 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.

   Measured: Baseline and after 6 weeks (post-intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted29 Dec 2025
2. Study start25 Mar 2025
3. Primary completionOct 2026 (estimated)
4. Study completionNov 2026 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Obesity & OverweightStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.