Functional Inspiratory Muscle Training in Obese Individuals

NCT06280183 | Completed

• 1 other identifier: 323132
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

obesity; respiratory muscle training; exercise; prevention

Outcome Measures

Primary Outcomes (1)

• Functional Capacity

  Submaximal functional exercise capacity of the participants will be evaluated with six- minute walk test.

  10 weeks

Secondary Outcomes (13)

• Comorbidity Assessment

  Day 1

• Physical Activity Assessment

  10 weeks

• Edmonton Obesity Staging System (EOSS)

  Day 1

• Peripheral Muscle Strength

  10 weeks

• Waist circumference

  10 weeks

Study Arms (3)

Aerobic and Resistive Exercise Training

ACTIVE COMPARATOR

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

Functional Inspiratory Muscle Training Group in obese individuals:

EXPERIMENTAL

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

Control Group:

NO INTERVENTION

Patient education will be given and no intervention will be made.

Interventions

Aerobic+Resistive Exercise Traning OTHER

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).

Aerobic and Resistive Exercise Training

Functional Inspiratory Muscle Training OTHER

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.

Functional Inspiratory Muscle Training Group in obese individuals:

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biruni University: lead
• Istanbul Galata University: collaborator

Study Sites (1)

Biruni University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Buket Akinci, Assoc. Prof.

  Biruni University

  STUDY CHAIR

• Alihan Oral, Assoc. Prof.

  Biruni University Hospital

  STUDY DIRECTOR

• Safak Yigit, MSc

  Biruni University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The assessor will be blind to the group allocation, and participants will be blind to group allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof.

Model Details: This is a randomized, single-blind study three arm study.

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: February 28, 2024
• Study Start: February 28, 2024
• Primary Completion: August 30, 2025
• Study Completion: March 23, 2026
• Last Updated: March 27, 2026

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)