Assessment of Respiratory Dysfunction in Obesity and the Use of IMT.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: inspiratory muscle training, placebo-IMT.
- Who it may be relevant to
- Registry conditions: Obesity & Overweight, Inflammation, Ventilation Disorders. Basic parameters: 30 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Functional Respiratory Tract Dysfunctions in Individuals With Obesity Undergoing Experimental Inspiratory Muscle Training.
Overview
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.
Interventions
- 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. - 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.
Primary outcome measures
- Pulmonary function test [Time frame: Baseline and after 6 weeks (post-intervention)]
- Respiratory muscle strength (PImax/PEmax) [Time frame: Baseline and after 6 weeks (post-intervention)]
- Forced oscillation technique (FOT) [Time frame: Baseline and after 6 weeks (post-intervention)]
- Laboratory tests [Time frame: Baseline and after 6 weeks (post-intervention)]
Secondary outcome measures (3)
- Body Composition (Bioelectrical Impedance Analysis, BIA) [Time frame: Baseline and after 6 weeks (post-intervention)]
- World Health Organization - Quality of Life - BREF (WHOQOL-BREF) [Time frame: Baseline and after 6 weeks (post-intervention)]
- International Physical Activity Questionnaire - short version (IPAQ - short version) [Time frame: Baseline and after 6 weeks (post-intervention)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Basic science
Study locations
Poland · 1 center
- Wroclaw University of Health and Sport Sciences — Wroclaw
Identifiers
NCT: NCT07307417 · 00913