Clinical trial NCT06280183: Functional Inspiratory Muscle Training in Obese Individuals
Official title: The Investigation of the Effects of Functional Inspiratory Muscle Training in Obese Individuals
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Keywords: obesity
respiratory muscle training
exercise
prevention
Lead sponsor: Biruni University
Sponsor class: OTHER
Collaborators: name: Istanbul Galata University
First posted: 2024-02-28
Enrollment: 45
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized, single-blind study three arm study.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Respiratory Muscle Strength
timeFrame: 10 weeks
measure: Incremental load test (Respiratory Muscle Endurance)
timeFrame: 10 weeks
measure: Forced expiratory volume 1st second (Respiratory Function)
timeFrame: 10 weeks
measure: Forced vital capacity (Respiratory Function)
timeFrame: 10 weeks.
Secondary outcomes:
measure: Comorbidity Assessment
timeFrame: Day 1
measure: Physical Activity Assessment
timeFrame: 10 weeks
measure: Edmonton Obesity Staging System (EOSS)
timeFrame: Day 1
measure: Functional Capacity
timeFrame: 10 weeks
measure: Peripheral Muscle Strength
timeFrame: 10 weeks
measure: Waist circumference
timeFrame: 10 weeks
measure: Hip circumference
timeFrame: 10 weeks
measure: Body fat-muscle ratios
timeFrame: 10 weeks
measure: Glucose profile
timeFrame: 10 weeks
measure: Lipid profile
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Biruni University
Study officials:
affiliation: Biruni University
name: Buket Akinci, Assoc. Prof.
role: STUDY_CHAIR
affiliation: Biruni University Hospital
name: Alihan Oral, Assoc. Prof.
role: STUDY_DIRECTOR
affiliation: Biruni University
name: Safak Yigit, MSc
role: PRINCIPAL_INVESTIGATOR
References: