ObesityNCT06280183
Functional Inspiratory Muscle Training in Obese Individuals
A study testing Functional Inspiratory Muscle Training and Aerobic+Resistive Exercise Traning in people with Obesity, run by Biruni University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Functional Inspiratory Muscle Training and Aerobic+Resistive Exercise Traning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Feb 2024to 23 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Investigation of the Effects of Functional Inspiratory Muscle Training in Obese Individuals
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Functional Inspiratory Muscle Training, Aerobic+Resistive Exercise Traning
- Keywords
- obesity, respiratory muscle training, exercise, prevention
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Inspiratory Muscle TrainingOther
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 TraningOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Other: Functional Inspiratory Muscle Training |
| Control Group: | No intervention | Patient education will be given and no intervention will be made. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Capacity
Submaximal functional exercise capacity of the participants will be evaluated with six- minute walk test.
Measured: 10 weeks
Secondary outcomes (13)
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+).
Measured: Day 1
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.
Measured: 10 weeks
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.
Measured: Day 1
Peripheral Muscle Strength
- 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.
Measured: 10 weeks
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.
Measured: 10 weeks
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.
Measured: 10 weeks
Body fat-muscle ratios
These measurements will be determined by bioelectrical impedance.
Measured: 10 weeks
Glucose profile
Glucose profile after 12 hours of fasting will be measured
Measured: 10 weeks
Lipid profile
Lipid profile after 12 hours of fasting will be measured
Measured: 10 weeks
Respiratory Muscle Strength
Respiratory muscle strength; it will be evaluated with an intraoral pressure measuring device in a sitting position.
Measured: 10 weeks
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)
Measured: 10 weeks
Forced expiratory volume 1st second (Respiratory function)
Spirometric assessment will be performed to determine participants' forced expiratory volume in one second (FECV1).
Measured: 10 weeks
Forced vital capacity (Respiratory function)
Spirometric assessment will be performed to determine participants' forced vital capacity (FVC)
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start28 Feb 2024
- Primary completion30 Aug 2025
- Study completion23 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, single-blind study three arm study.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul Galata University
- Responsible party
- Principal investigator, Buket AKINCI, Biruni University
- Investigators
- Buket Akinci, Assoc. Prof., Study chair, Biruni UniversityAlihan Oral, Assoc. Prof., Study director, Biruni University HospitalSafak Yigit, MSc, Principal investigator, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06280183
- Sponsor's protocol ID
- 323132
- Status last verified
- May 2024
- First submitted
- 26 Jan 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Investigation of the Effects of Functional Inspiratory Muscle Training in Obese Individuals
- ClinicalTrials.gov ID
- NCT06280183
- Acronym / sponsor ID
- 323132
- Conditions
- Obesity
- Keywords
- obesity, respiratory muscle training, exercise, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Collaborators
- Istanbul Galata University
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 23 Mar 2026 (actual)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- This is a randomized, single-blind study three arm study.
| Arm | Type | Receives |
|---|---|---|
| Aerobic and Resistive Exercise Training | Active comparator | Other: Aerobic+Resistive Exercise TraningThe 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). |
| Functional Inspiratory Muscle Training Group in obese individuals: | Experimental | Other: Functional Inspiratory Muscle TrainingInspiratory 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. |
| Control Group: | No intervention | –Patient education will be given and no intervention will be made. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Inspiratory Muscle TrainingInspiratory 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. | Other | Functional Inspiratory Muscle Training Group in obese individuals: |
| Aerobic+Resistive Exercise TraningAerobic 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). | Other | Aerobic and Resistive Exercise Training |
Primary outcome
Functional Capacity
Time frame: 10 weeks
Submaximal functional exercise capacity of the participants will be evaluated with six- minute walk test.
13 secondary outcomes
Comorbidity Assessment
Time frame: Day 1
Physical Activity Assessment
Time frame: 10 weeks
Edmonton Obesity Staging System (EOSS)
Time frame: Day 1
Peripheral Muscle Strength
Time frame: 10 weeks
Waist circumference
Time frame: 10 weeks
Hip circumference
Time frame: 10 weeks
Body fat-muscle ratios
Time frame: 10 weeks
Glucose profile
Time frame: 10 weeks
Lipid profile
Time frame: 10 weeks
Respiratory Muscle Strength
Time frame: 10 weeks
Incremental load test (Respiratory muscle endurance)
Time frame: 10 weeks
Forced expiratory volume 1st second (Respiratory function)
Time frame: 10 weeks
Forced vital capacity (Respiratory function)
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Buket Akinci, Assoc. Prof. study chair
Biruni University
Alihan Oral, Assoc. Prof. study director
Biruni University Hospital
Safak Yigit, MSc principal investigator
Biruni University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Inspiratory Muscle Training and Aerobic+Resistive Exercise Traning in people with Obesity, run by Biruni University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Capacity (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.