Functional Inspiratory Muscle Training in Obese Individuals

Not Applicable

Recruiting

• Conditions: Obesity

• Registration Number: NCT06280183
• Lead Sponsor: Biruni University

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.

Study Timeline

• Study First Submitted: 2024-01-26
• Study First Submitted QC: 2024-02-20
• Study Start: 2024-02-28
• Study First Posted: 2024-02-28
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-09
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Forced vital capacity (Respiratory Function)	10 weeks.	Spirometric assessment will be performed to determine participants' forced vital capacity (FVC).
Forced expiratory volume 1st second (Respiratory Function)	10 weeks	Spirometric assessment will be performed to determine participants' forced expiratory volume in one second (FEV1).
Respiratory Muscle Strength	10 weeks	Respiratory muscle strength; It will be evaluated with an intraoral pressure measuring device in a sitting position.
Incremental load test (Respiratory Muscle Endurance)	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).

Secondary Outcome Measures

Name	Time	Method
Waist circumference	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.
Peripheral Muscle Strength	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.
Comorbidity Assessment	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+).
Functional Capacity	10 weeks	Submaximal functional exercise capacity of the participants will be evaluated with the six-minute walk test.
Glucose profile	10 weeks	Glucose profile after 12 hours of fasting will be measured
Edmonton Obesity Staging System (EOSS)	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.
Physical Activity Assessment	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.
Hip circumference	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.
Body fat-muscle ratios	10 weeks	These measurements will be determined by bioelectrical impedance.
Lipid profile	10 weeks	Lipid profile after 12 hours of fasting will be measured

Trial Locations

Locations (1)

Biruni University; 🇹🇷 Istanbul, Turkey