Functional Inspiratory Muscle Training in Obese Individuals

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06280183
• Other study ID #: 323132
• Status: Recruiting
• Phase: N/A
• Start date: February 28, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: Biruni University
• Contact: Buket Akinci, Assoc.Prof.
• Phone: +90 212 444 8 276
• Email: bakinci[@]biruni.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Respiratory Aspiration

Intervention

Other:
• Functional Inspiratory Muscle Training
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
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).

Locations

Country	Name	City	State
Turkey	Biruni University	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Biruni University	Istanbul Galata University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory Muscle Strength	Respiratory muscle strength; It will be evaluated with an intraoral pressure measuring device in a sitting position.	10 weeks
Primary	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).	10 weeks
Primary	Forced expiratory volume 1st second (Respiratory Function)	Spirometric assessment will be performed to determine participants' forced expiratory volume in one second (FEV1).	10 weeks
Primary	Forced vital capacity (Respiratory Function)	Spirometric assessment will be performed to determine participants' forced vital capacity (FVC).	10 weeks.
Secondary	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+).	Day 1
Secondary	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.	10 weeks
Secondary	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.	Day 1
Secondary	Functional Capacity	Submaximal functional exercise capacity of the participants will be evaluated with the six-minute walk test.	10 weeks
Secondary	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.	10 weeks
Secondary	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.	10 weeks
Secondary	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.	10 weeks
Secondary	Body fat-muscle ratios	These measurements will be determined by bioelectrical impedance.	10 weeks
Secondary	Glucose profile	Glucose profile after 12 hours of fasting will be measured	10 weeks
Secondary	Lipid profile	Lipid profile after 12 hours of fasting will be measured	10 weeks