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Clinical Trials/NCT06280183
NCT06280183
Recruiting
Not Applicable

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

Biruni University1 site in 1 country45 target enrollmentFebruary 28, 2024
ConditionsObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Biruni University
Enrollment
45
Locations
1
Primary Endpoint
Forced vital capacity (Respiratory Function)
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 28, 2024
End Date
June 30, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Biruni University
Responsible Party
Principal Investigator
Principal Investigator

Buket AKINCI

Assoc.Prof.

Biruni University

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)

Outcomes

Primary Outcomes

Forced vital capacity (Respiratory Function)

Time Frame: 10 weeks.

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

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 (FEV1).

Respiratory Muscle Strength

Time Frame: 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)

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).

Secondary Outcomes

  • Waist circumference(10 weeks)
  • Peripheral Muscle Strength(10 weeks)
  • Comorbidity Assessment(Day 1)
  • Functional Capacity(10 weeks)
  • Glucose profile(10 weeks)
  • Edmonton Obesity Staging System (EOSS)(Day 1)
  • Physical Activity Assessment(10 weeks)
  • Hip circumference(10 weeks)
  • Body fat-muscle ratios(10 weeks)
  • Lipid profile(10 weeks)

Study Sites (1)

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