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NCT Number: NCT06280183

Functional Inspiratory Muscle Training in Obese Individuals

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.

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Key information

Conditions

Obesity Behavior Body Weight Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Biruni University

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Functional Inspiratory Muscle Training

Other

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.

Aerobic+Resistive Exercise Traning

Other

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).

Primary outcomes

  1. Functional Capacity

    Time frame: 10 weeks

    Submaximal functional exercise capacity of the participants will be evaluated with six- minute walk test.

Secondary outcomes

  1. Comorbidity Assessment

    Time frame: Day 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+).

  2. Physical Activity Assessment

    Time frame: 10 weeks

    Step 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.

  3. Edmonton Obesity Staging System (EOSS)

    Time frame: Day 1

    The Edmonton Obesity Staging System (EOSS) is a five-stage obesity classification system used to determine prognosis and guide treatment when assessing obesity-related risk.

  4. Peripheral Muscle Strength

    Time frame: 10 weeks

    M. 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.

  5. Waist circumference

    Time frame: 10 weeks

    Waist circumference will be measured at belly level with the patient in an upright position during expiration, with both feet bearing equal weight.

  6. Hip circumference

    Time frame: 10 weeks

    Hip 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.

  7. Body fat-muscle ratios

    Time frame: 10 weeks

    These measurements will be determined by bioelectrical impedance.

  8. Glucose profile

    Time frame: 10 weeks

    Glucose profile after 12 hours of fasting will be measured

  9. Lipid profile

    Time frame: 10 weeks

    Lipid profile after 12 hours of fasting will be measured

  10. Respiratory Muscle Strength

    Time frame: 10 weeks

    Respiratory muscle strength; it will be evaluated with an intraoral pressure measuring device in a sitting position.

  11. Incremental load test (Respiratory muscle endurance)

    Time frame: 10 weeks

    Respiratory muscle endurance will be evaluated by incremental load test. The incremental load test will be performed using the electronic inspiratory loading device (PowerBreathe-KHP2)

  12. Forced expiratory volume 1st second (Respiratory function)

    Time frame: 10 weeks

    Spirometric assessment will be performed to determine participants' forced expiratory volume in one second (FECV1).

  13. Forced vital capacity (Respiratory function)

    Time frame: 10 weeks

    Spirometric assessment will be performed to determine participants' forced vital capacity (FVC)

Sponsors and collaborators

Lead sponsor

Biruni University

Other

Collaborators

  • Istanbul Galata University

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Feb 28, 2024
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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