Respiratory MuscleNCT06494930
The Effect of Functional Respiratory Muscle Training on Respiratory Function and Physical Performance
A study testing F-IMT and Core Stabilization Exercise in people with Respiratory Muscle and Exercise, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
The study aims to investigate the effects of core stabilization exercise, which includes functional respiratory muscle training, on respiratory function, aerobic capacity, trunk stabilization, and physical performance in football players. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Respiratory Muscle, Exercise
- What is being tested?
- F-IMT and Core Stabilization Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2024to 15 Feb 2025
- 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 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Professional or recreational athlete Must be approved participation Must be ability to cooperate with the exercise training and evaluation methods to be applied
Who cannot join
- Have surgery within the last six months Cardiovascular or pulmonary disease Taking a break from sports
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Yunus Emre TÜTÜNEKEN
Istanbul, Zeytinburnu, 34010
About this study
Official title: The Effect of Functional Respiratory Muscle Training on Respiratory Function and Physical Performance in Football Players
The study aims to investigate the effects of core stabilization exercise, which includes functional respiratory muscle training, on respiratory function, aerobic capacity, trunk stabilization, and physical performance in football players.
Licensed athletes who actively engage in sports and play football will be included in the project. Volunteers included in the study will be randomly divided into two groups: study and control groups. Different methods will be used in the study for respiratory function testing, respiratory muscle strength measurement, trunk stabilization evaluation, and performance evaluation. To apply these methods, a spirometer device (according to ATS/ERS criteria with Cosmed Pony FX, Italy), portable, electronic oral pressure measurement device (with Micro Medical Micro RPM, Rochester, England), Plank and Sorenson tests will be used. A core stabilization exercise protocol including functional respiratory muscle training will be applied to the study group. The control group will only apply the same core stabilization exercise protocol as the study group.
This study aims to investigate the effects of functional respiratory muscle training and to add it to the training program of athletes according to the results.
Read the detailed description
Football is a sport branch that requires a high degree of coordination, using motoric properties such as general endurance and coordination, as well as aerobic and anaerobic efforts. Studies argue that core strength positively affects athletic performance, reduces the risk of injury, and has an effect on the treatment of pain in the back area. Core stability is very important in terms of sports performance. Respiratory functions of all athletes, regardless of sports branches; It varies depending on physiological, functional, and psychological factors. Because disruption of respiratory muscle functions or respiratory muscle fatigue is a factor that jeopardizes the exercise performance of athletes. Numerous studies have shown that respiratory muscle training reduces respiratory muscle fatigue and sympatho-excitation during intense exercise. Previous studies focusing on the effects of respiratory muscle training have shown increased respiratory muscle strength in triathletes and marathon runners, rowers, cyclists, and divers. There are a limited number of studies investigating the effect of respiratory muscle training on football players. Our study, based on research in recent literature, aims to investigate the effects of core stabilization exercise, which includes functional respiratory muscle training, on respiratory function, aerobic capacity, trunk stabilization, and physical performance in football players.
Licensed athletes who actively engage in sports and play football will be included in the project. Volunteers included in the study will be randomly divided into two groups: study and control groups. Different methods will be used in the study for respiratory function test (PFT), measurement of respiratory muscle strength, trunk stabilization evaluation, and performance evaluation. To apply these methods, a spirometer device (according to ATS/ERS criteria with Cosmed Pony FX, Italy), portable, electronic oral pressure measurement device (with Micro Medical Micro RPM, Rochester, England), Plank and Sorenson tests will be used. A core stabilization exercise protocol including functional respiratory muscle training will be applied to the study group. The control group will only apply the same core stabilization exercise protocol as the study group.
This study aims to investigate the effects of functional respiratory muscle training and to add it to the training program of athletes according to the results. Aiming to improve the health and working dynamics of the respiratory muscles in athletes by applying functional muscle training to participants, as well as showing its effect on instant and prospective performance in athletes, is the ultimate goal to be shaped by the study findings. The study will shed light on this aspect with its functioning and method for researchers in the field. With the analysis and presentation of the data obtained from our study, the gaps in the current literature will be filled.
- Conditions
- Respiratory Muscle, Exercise
- Being tested
- F-IMT, Core Stabilization Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F-IMTOther
A core stabilization exercise protocol including functional respiratory muscle training will be applied to the F-IMT group. IMT will be provided with the red Powerbreath Plus MR exercise device. Initial training intensity will be set at 50% of the MIP value measured at the athlete's first evaluation. Every two weeks, the athlete will be re-evaluated the new MIP value will be measured, and the training intensity will be adjusted to 50% of the newly measured MIP value. After the nose clip is attached, the athlete will be asked to take the device's mouthpiece into his mouth, close his lips tightly, and take a deep, fast, and powerful breath, then exhale slowly and completely with minimal effort. While the athlete does breathing exercises with the device, he will also do core stabilization exercises. Athletes will be asked to train 30 minutes daily, five days a week, for six weeks.
Core Stabilization ExerciseOther
Only the core stabilization exercise protocol will be applied to the control group. Athletes will be asked to train 30 minutes a day, five days a week, for six weeks.
| Study group | Role | What they receive |
|---|---|---|
| F-IMT Group | Experimental | Participants in this group will perform functional IMT under supervision 5 days a week. In functional IMT, the core stabilization exercise protocol will be applied at the same time as the participants practice the breathing exercise with the device. Receives: Other: F-IMT |
| Control Group | Active comparator | Participants in this group will also apply a core stabilization exercise protocol under supervision 5 days a week. Receives: Other: Core Stabilization Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
İnspiratory muscle strength measurement
The athletes' maximum inspiratory intraoral pressure (MIP) will be measured by a portable, electronic oral pressure measuring device, and the values will be recorded in cmH2O.
Measured: 6 week
Plank Test
Subjects are asked to lie face down, stand on their toes with their forearms and elbows bilaterally shoulder-width apart, lift the pelvis, and form a straight line parallel to the floor with their neck, shoulders, back, hips, and legs, and the subject maintains this posture. Once the time starts, the time until the subject gets tired and/or breaks his posture is recorded in seconds.
Measured: 6 week
Sorenson Test
For this test, the athlete will be laid face down with his body hanging off the bed from the anterior superior iliac spine. The athlete is asked to keep his body parallel to the ground against gravity, with his legs fixed at the gastrocnemius muscle level and his hands clasped on his chest. Partial trunk extension is allowed. When posture is impaired and/or the athlete quits the experiment due to fatigue and pain, the time is stopped and the score in seconds is recorded.
Measured: 6 week
Y Balance Test
The "Y Balance Test" platform will be used to measure dynamic postural control. Each participant's leg length will be recorded in centimeters by measuring bilaterally in the supine position from the anterior superior iliac point to the distal part of the medial malleolus. Measurements will be tested barefoot, in 3 directions, with ANT reaching as the distance between the participant's central toe tip and PL and PM as the distance between the farthest point the participant can reach from the heel of the foot.
Measured: 6 week
Ekspiratory muscle strength measurement
The athletes' maximum expiratory intraoral pressure (MEP) will be measured by a portable, electronic oral pressure measuring device, and the values will be recorded in cmH2O.
Measured: 6 week
Secondary outcomes (4)
The forced vital capacity (FVC)
In the respiratory function test, the athletes' forced vital capacity (FVC) will be measured with a portable spirometer. Pulmonary function test parameters will be expressed in liters and percentage of the expected value. Respiratory function test will be performed with a spirometer device according to ATS/ERS criteria.
Measured: 6 week
The forced expiratory volume in the first second (FEV1)
In the respiratory function test, the athletes' forced expiratory volume in the first second (FEV1) will be measured with a portable spirometer. Pulmonary function test parameters will be expressed in liters and percentage of the expected value. Respiratory function test will be performed with a spirometer device according to ATS/ERS criteria.
Measured: 6 week
The forced expiratory volume in the first second to forced vital capacity (FEV1/FVC)
In the respiratory function test, the athletes' ratio of forced expiratory volume in the first second to forced vital capacity (FEV1/FVC) will be measured with a portable spirometer. Pulmonary function test parameters will be expressed in liters and percentage of the expected value. Respiratory function test will be performed with a spirometer device according to ATS/ERS criteria.
Measured: 6 week
The peak flow rate (PEF)
In the respiratory function test, the athletes' peak flow rate (PEF) will be measured with a portable spirometer. Pulmonary function test parameters will be expressed in liters and percentage of the expected value. Respiratory function test will be performed with a spirometer device according to ATS/ERS criteria.
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start15 Jul 2024
- Primary completion15 Dec 2024
- Study completion15 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory MuscleStudies of the same condition, open and under way.
- More trials run by Istinye 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunus Emre Tutuneken, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06494930
- Sponsor's protocol ID
- 12
- Status last verified
- Apr 2025
- First submitted
- 2 Jun 2024
- Last updated
- 17 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Functional Respiratory Muscle Training on Respiratory Function and Physical Performance in Football Players
- ClinicalTrials.gov ID
- NCT06494930
- Acronym / sponsor ID
- 12
- Conditions
- Respiratory Muscle, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 15 Feb 2025 (actual)
- First posted
- 10 Jul 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.
The study aims to investigate the effects of core stabilization exercise, which includes functional respiratory muscle training, on respiratory function, aerobic capacity, trunk stabilization, and physical performance in football players.
Licensed athletes who actively engage in sports and play football will be included in the project. Volunteers included in the study will be randomly divided into two groups: study and control groups. Different methods will be used in the study for respiratory function testing, respiratory muscle strength measurement, trunk stabilization evaluation, and performance evaluation. To apply these methods, a spirometer device (according to ATS/ERS criteria with Cosmed Pony FX, Italy), portable, electronic oral pressure measurement device (with Micro Medical Micro RPM, Rochester, England), Plank and Sorenson tests will be used. A core stabilization exercise protocol including functional respiratory muscle training will be applied to the study group. The control group will only apply the same core stabilization exercise protocol as the study group.
This study aims to investigate the effects of functional respiratory muscle training and to add it to the training program of athletes according to the results.
Detailed description
Football is a sport branch that requires a high degree of coordination, using motoric properties such as general endurance and coordination, as well as aerobic and anaerobic efforts. Studies argue that core strength positively affects athletic performance, reduces the risk of injury, and has an effect on the treatment of pain in the back area. Core stability is very important in terms of sports performance. Respiratory functions of all athletes, regardless of sports branches; It varies depending on physiological, functional, and psychological factors. Because disruption of respiratory muscle functions or respiratory muscle fatigue is a factor that jeopardizes the exercise performance of athletes. Numerous studies have shown that respiratory muscle training reduces respiratory muscle fatigue and sympatho-excitation during intense exercise. Previous studies focusing on the effects of respiratory muscle training have shown increased respiratory muscle strength in triathletes and marathon runners, rowers, cyclists, and divers. There are a limited number of studies investigating the effect of respiratory muscle training on football players. Our study, based on research in recent literature, aims to investigate the effects of core stabilization exercise, which includes functional respiratory muscle training, on respiratory function, aerobic capacity, trunk stabilization, and physical performance in football players.
Licensed athletes who actively engage in sports and play football will be included in the project. Volunteers included in the study will be randomly divided into two groups: study and control groups. Different methods will be used in the study for respiratory function test (PFT), measurement of respiratory muscle strength, trunk stabilization evaluation, and performance evaluation. To apply these methods, a spirometer device (according to ATS/ERS criteria with Cosmed Pony FX, Italy), portable, electronic oral pressure measurement device (with Micro Medical Micro RPM, Rochester, England), Plank and Sorenson tests will be used. A core stabilization exercise protocol including functional respiratory muscle training will be applied to the study group. The control group will only apply the same core stabilization exercise protocol as the study group.
This study aims to investigate the effects of functional respiratory muscle training and to add it to the training program of athletes according to the results. Aiming to improve the health and working dynamics of the respiratory muscles in athletes by applying functional muscle training to participants, as well as showing its effect on instant and prospective performance in athletes, is the ultimate goal to be shaped by the study findings. The study will shed light on this aspect with its functioning and method for researchers in the field. With the analysis and presentation of the data obtained from our study, the gaps in the current literature will be filled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| F-IMT Group | Experimental | Other: F-IMTParticipants in this group will perform functional IMT under supervision 5 days a week. In functional IMT, the core stabilization exercise protocol will be applied at the same time as the participants practice the breathing exercise with the device. |
| Control Group | Active comparator | Other: Core Stabilization ExerciseParticipants in this group will also apply a core stabilization exercise protocol under supervision 5 days a week. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Professional or recreational athlete Must be approved participation Must be ability to cooperate with the exercise training and evaluation methods to be applied
Key exclusion criteria (1 listed)
- Have surgery within the last six months Cardiovascular or pulmonary disease Taking a break from sports
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 |
|---|---|---|
| F-IMTA core stabilization exercise protocol including functional respiratory muscle training will be applied to the F-IMT group. IMT will be provided with the red Powerbreath Plus MR exercise device. Initial training intensity will be set at 50% of the MIP value measured at the athlete's first evaluation. Every two weeks, the athlete will be re-evaluated the new MIP value will be measured, and the training intensity will be adjusted to 50% of the newly measured MIP value. After the nose clip is attached, the athlete will be asked to take the device's mouthpiece into his mouth, close his lips tightly, and take a deep, fast, and powerful breath, then exhale slowly and completely with minimal effort. While the athlete does breathing exercises with the device, he will also do core stabilization exercises. Athletes will be asked to train 30 minutes daily, five days a week, for six weeks. | Other | F-IMT Group |
| Core Stabilization ExerciseOnly the core stabilization exercise protocol will be applied to the control group. Athletes will be asked to train 30 minutes a day, five days a week, for six weeks. | Other | Control Group |
Primary outcome
İnspiratory muscle strength measurement
Time frame: 6 week
The athletes' maximum inspiratory intraoral pressure (MIP) will be measured by a portable, electronic oral pressure measuring device, and the values will be recorded in cmH2O.
Plank Test
Time frame: 6 week
Subjects are asked to lie face down, stand on their toes with their forearms and elbows bilaterally shoulder-width apart, lift the pelvis, and form a straight line parallel to the floor with their neck, shoulders, back, hips, and legs, and the subject maintains this posture. Once the time starts, the time until the subject gets tired and/or breaks his posture is recorded in seconds.
Sorenson Test
Time frame: 6 week
For this test, the athlete will be laid face down with his body hanging off the bed from the anterior superior iliac spine. The athlete is asked to keep his body parallel to the ground against gravity, with his legs fixed at the gastrocnemius muscle level and his hands clasped on his chest. Partial trunk extension is allowed. When posture is impaired and/or the athlete quits the experiment due to fatigue and pain, the time is stopped and the score in seconds is recorded.
Y Balance Test
Time frame: 6 week
The "Y Balance Test" platform will be used to measure dynamic postural control. Each participant's leg length will be recorded in centimeters by measuring bilaterally in the supine position from the anterior superior iliac point to the distal part of the medial malleolus. Measurements will be tested barefoot, in 3 directions, with ANT reaching as the distance between the participant's central toe tip and PL and PM as the distance between the farthest point the participant can reach from the heel of the foot.
Ekspiratory muscle strength measurement
Time frame: 6 week
The athletes' maximum expiratory intraoral pressure (MEP) will be measured by a portable, electronic oral pressure measuring device, and the values will be recorded in cmH2O.
4 secondary outcomes
The forced vital capacity (FVC)
Time frame: 6 week
The forced expiratory volume in the first second (FEV1)
Time frame: 6 week
The forced expiratory volume in the first second to forced vital capacity (FEV1/FVC)
Time frame: 6 week
The peak flow rate (PEF)
Time frame: 6 week
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 17 Apr 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing F-IMT and Core Stabilization Exercise in people with Respiratory Muscle and Exercise, run by Istinye 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 1 inclusion and 1 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 17 Apr 2025. 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?
İnspiratory muscle strength measurement (time frame: 6 week). The study lists 5 primary outcomes in all. 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 17 Apr 2025.