An interventional study of Functional Inspiratory Muscle Training and Aerobic+Resistive Exercise Traning in Obesity, sponsored by Biruni University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 25 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by Biruni University · Not applicable, Interventional, and Treatment
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.
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 45 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
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Exclusion Criteria:
The exercise program will start with a 5-10 minute warm-up and end with a 5-10 minute cool down. Aerobic exercise is planned at 60-85% of Maximum Heart Rate on the bike for 30-40 minutes. Resistive exercise program, covering all major 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 muscles, abdominal muscles and lower extremity muscles, 1-3 sets of 10-15 repetitions will be planned as 40-70% of 1 maximum repetition (1RM).
Other: Aerobic+Resistive Exercise Traning
Inspiratory muscle training will be applied simultaneously with aerobic exercise. This program will create the functional IMT. The exercise program will start with a 5-10 minute warm-up and cool down. Aerobic exercise is planned at 60-85% of MHR on the bike for 30-40 minutes, progress will be achieved. Participants will first 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. After 10 consecutive breathing cycles, participants will be asked to perform 3-4 breath checks. Resistive exercise program, covering 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 muscles, abdominal muscles and lower extremity muscles, 1-3 sets of 10-15 repetitions will be planned as 40-70% of 1RM.
Other: Functional Inspiratory Muscle Training
Patient education will be given and no intervention will be made.
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 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).
Functional Capacity
Submaximal functional exercise capacity of the participants will be evaluated with six- minute walk test.
Time frame: 10 weeks
Comorbidity Assessment
"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+).
Time frame: Day 1
Physical Activity Assessment
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.
Time frame: 10 weeks
Edmonton Obesity Staging System (EOSS)
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.
Time frame: Day 1
Peripheral Muscle Strength
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.
Time frame: 10 weeks
Waist circumference
Waist circumference will be measured at belly level with the patient in an upright position during expiration, with both feet bearing equal weight.
Time frame: 10 weeks
Hip circumference
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.
Time frame: 10 weeks
Body fat-muscle ratios
These measurements will be determined by bioelectrical impedance.
Time frame: 10 weeks
Glucose profile
Glucose profile after 12 hours of fasting will be measured
Time frame: 10 weeks
Lipid profile
Lipid profile after 12 hours of fasting will be measured
Time frame: 10 weeks
Respiratory Muscle Strength
Respiratory muscle strength; it will be evaluated with an intraoral pressure measuring device in a sitting position.
Time frame: 10 weeks
Incremental load test (Respiratory muscle endurance)
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)
Time frame: 10 weeks
Forced expiratory volume 1st second (Respiratory function)
Spirometric assessment will be performed to determine participants' forced expiratory volume in one second (FECV1).
Time frame: 10 weeks
Forced vital capacity (Respiratory function)
Spirometric assessment will be performed to determine participants' forced vital capacity (FVC)
Time frame: 10 weeks
Plan to share: No
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