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Functional Inspiratory Muscle Training in Obese Individuals

The Investigation of the Effects of Functional Inspiratory Muscle Training in Obese Individuals

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06280183
Enrollment
45
Registered
2024-02-28
Start date
2024-02-28
Completion date
2026-03-23
Last updated
2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

obesity, respiratory muscle training, exercise, prevention

Brief summary

In obese individuals, increased adipose tissue and systemic inflammation play a key role in the development of cardiometabolic diseases, pulmonary system dysfunction, and many respiratory diseases. Existing research has demonstrated beneficial clinical outcomes of inspiratory muscle training or combined aerobic and resistance exercise training in obese individuals. However, this focused on the isolated effects of exercise on obesity. In the current literature, no study is evaluating the effectiveness of functional inspiratory muscle training in obese individuals. This study aims to investigate the effects of functional inspiratory muscle training on body composition, cardiometabolic markers, functional capacity, respiratory function, respiratory muscle strength, and respiratory muscle performance in obese individuals.

Detailed description

Obesity is characterized by increased adipose tissue and systemic inflammation that play a key role in the development of non-communicable chronic diseases. It is well known that individuals with obesity have decreased exercise capacity and muscle weakness in both peripheral and respiratory muscles. Exercise training is recommended in addition to healthy dietary habits in managing obesity. Current literature demonstrated beneficial clinical outcomes of isolated inspiratory muscle training or combined aerobic and resistance exercise training in obese individuals. Functional inspiratory muscle training is a method that combines both aerobic exercise and inspiratory muscle training. In the current literature, no study is evaluating the effectiveness of functional inspiratory muscle training in obese individuals. The aim of this study is to investigate the effect of functional inspiratory muscle training on body composition, cardiometabolic markers, functional capacity, respiratory function, respiratory muscle strength and respiratory muscle performance in obese individuals.

Interventions

Inspiratory muscle training is a technique that combines aerobic training with inspiratory muscle training. will be applied simultaneously with aerobic exercise. Participants will work with bicycle ergometry and then continue with IMT in the same session for the first three weeks. The intensity of IMT exercise will be set at 40-60% of MIP.

OTHERAerobic+Resistive Exercise Traning

Aerobic exercise is planned at 60-85% of the Maximum Heart Rate on a cycle ergometer for 30-40 minutes. Resistive exercise will cover all major muscle groups. The upper body (pectoralis, latissimus dorsi, rotator cuff muscles, deltoid, biceps, triceps), abdominal muscles, and lower extremities (quadriceps, hamstring, gastrosoleus) will be exercised to strengthen. For upper body, abdominal, and lower extremity muscles, 1-3 sets of 10-15 repetitions will be planned as 40-70% of 1 maximum repetition (1RM).

Sponsors

Biruni University
Lead SponsorOTHER
Istanbul Galata University
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

The assessor will be blind to the group allocation, and participants will be blind to group allocation

Intervention model description

This is a randomized, single-blind study three arm study.

Eligibility

Sex/Gender
ALL
Age
25 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* Those between the ages of 25-60 * According to the World Health Organization (WHO) classification, those with a body mass index between 30-40 kg/m2 * Volunteering to participate in the research

Exclusion criteria

* According to the World Health Organization (WHO) classification, body mass index is over 40 kg/m2 * Functional class III or IV according to the New York Heart Association (NYHA) classification * Those with a Charlson comorbidity score of 3 and above * Uncontrolled hypertension, diabetes and unstable angina pectoris * Cooperative disorders, orthopedic and neurological problems that may interfere with evaluation and treatment * Individuals with a history of lower extremity-related injury or surgery in the last six months * Being diagnosed with diabetes and having complications such as nephropathy, retinopathy and neuropathy * Those with accompanying chronic respiratory disease * Those with acute infection * Individuals with middle ear-related pathologies (such as tympanic membrane rupture, otitis) * Those with a STOP-Bang score of 3 and above * Individuals with a history of spontaneous or trauma-related pneumothorax * Smokers * Pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Functional Capacity10 weeksSubmaximal functional exercise capacity of the participants will be evaluated with six- minute walk test.

Secondary

MeasureTime frameDescription
Comorbidity AssessmentDay 1"Charlson Comorbidity Index" (CMI) will be used to determine the comorbidity levels of obese individuals. The index, which consists of nineteen comorbid diagnosis groups, is a valid method for evaluating chronic diseases and measuring their relationship with mortality. All CMI scores are scored between 0-37. According to the results, 3 levels of comorbidity are defined: low (0), medium (1-2) and high (3+).
Physical Activity Assessment10 weeksStep Count Measurement: Daily step count will be monitored to determine the physical activity level of the participants. Step count will be assessed with a wearable activity monitor, a portable, easy-to-use tool that can measure objectively (Huawei Watch Fit Special Edition). With its six-axis sensor, the device records the user's physical activity style information in its temporary memory throughout the duration of use. Participants will be asked to wear the activity monitor on their left wrist throughout and only remove it during bathing. After one week of use, the data recorded with the wearable activity monitor will be taken.
Edmonton Obesity Staging System (EOSS)Day 1The Edmonton Obesity Staging System (EOSS) is a five-stage obesity classification system used to determine prognosis and guide treatment when assessing obesity-related risk.
Peripheral Muscle Strength10 weeksM. Quadriceps muscle strength and hand grip strength measurement will be used to evaluate peripheral muscle strength. Hand-held dynamometer will be used to evaluate quadriceps muscle strength and hand grip strength.
Waist circumference10 weeksWaist circumference will be measured at belly level with the patient in an upright position during expiration, with both feet bearing equal weight.
Hip circumference10 weeksHip circumference will be measured at the level of the greater femoral trochanter, with the patient in an upright position, with both feet bearing equal weight.
Body fat-muscle ratios10 weeksThese measurements will be determined by bioelectrical impedance.
Glucose profile10 weeksGlucose profile after 12 hours of fasting will be measured
Lipid profile10 weeksLipid profile after 12 hours of fasting will be measured
Respiratory Muscle Strength10 weeksRespiratory muscle strength; it will be evaluated with an intraoral pressure measuring device in a sitting position.
Incremental load test (Respiratory muscle endurance)10 weeksRespiratory muscle endurance will be evaluated by incremental load test. The incremental load test will be performed using the electronic inspiratory loading device (PowerBreathe-KHP2)
Forced expiratory volume 1st second (Respiratory function)10 weeksSpirometric assessment will be performed to determine participants' forced expiratory volume in one second (FECV1).
Forced vital capacity (Respiratory function)10 weeksSpirometric assessment will be performed to determine participants' forced vital capacity (FVC)

Countries

Turkey (Türkiye)

Contacts

STUDY_CHAIRBuket Akinci, Assoc. Prof.

Biruni University

STUDY_DIRECTORAlihan Oral, Assoc. Prof.

Biruni University Hospital

PRINCIPAL_INVESTIGATORSafak Yigit, MSc

Biruni University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026