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

NCT ID: NCT07307417

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2026-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity & Overweight Inflammation Ventilation Disorders

Keywords

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inspiratory muscle training obesity ventilation disorders inflammation forced oscillation technique spirometry

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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IMT Group

Group Type EXPERIMENTAL

inspiratory muscle training

Intervention Type 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.

placebo-IMT

Group Type PLACEBO_COMPARATOR

placebo-IMT

Intervention Type 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.

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wroclaw University of Health and Sport Sciences

OTHER

Sponsor Role lead

Responsible Party

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Paulina Okrzymowska

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dariusz Kałka, prof.

Role: PRINCIPAL_INVESTIGATOR

Wroclaw University of Health and Sport Sciences

Krystyna Rożek-Piechura, prof.

Role: STUDY_DIRECTOR

Wroclaw University of Health and Sport Sciences

Paulina Okrzymowska

Role: PRINCIPAL_INVESTIGATOR

Wroclaw University of Health and Sport Sciences

Locations

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Wroclaw University of Health and Sport Sciences

Wroclaw, Dolny Śląsk, Poland

Site Status

Countries

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Poland

Central Contacts

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Paulina Okrzymowska, phD

Role: CONTACT

Phone: +48 71 347 3520

Email: [email protected]

Facility Contacts

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Role: primary

Other Identifiers

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00913

Identifier Type: -

Identifier Source: org_study_id