- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06886503
Effects of Inspiratory Muscle Warm-up on Respiratory Variables, Physiological Indices, and 400-meter Performance in Elite Male Runners - Randomized Crossover Trial
Inspiratory Muscle Warm-up Improves 400-meter Performance in Elite Runners - Randomized Crossover Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Thirteen male 400-meter sprinters were included in analysis The participants' best recorded times ranged between 49.71 seconds and 51.74 seconds (Mean: 50.78±0.65 s). The required sample size was determined using*Power software (version 3.1.9.6; Dusseldorf, Germany), with a significance level of α = 0.05, statistical power (1 - β) = 0.95, and an effect size of ƒ = 0.5 (ANOVA with repeated measures, within interaction, 4 measurements) and totaled 10 participants. Initially, 14 athletes were recruited with convenience sampling by direct contact with coaches and athletes. One athlete dropped out during the study and did not complete all the required measurements and was not included in further analyses. All the participants were highly-trained athletes specializing in 400-meter sprint competitions, training six days per week.
Participants who voluntarily agreed to participate in the study and met the inclusion criteria were included after completing the Informed Consent Form. Upon obtaining approval from the responsible researcher and research supervisor, the warm-up protocols and physiological tests outlined in the study were initiated. The four different warm-up protocols were implemented in a randomized order: athletic warm-up alone, athletic warm-up + 60% inspiratory muscle warm-up, athletic warm-up + 40% inspiratory muscle warm-up, and athletic warm-up + 15% sham (placebo) inspiratory muscle warm-up. Immediately following each warm-up protocol, participants performed a 400-meter sprint, after which the physiological tests were repeated. The athletes were blinded to the applied protocol.
Athletic Warm-Up Protocol (AW) The athletic warm-up (AWU) consisted of 15 minutes of low-intensity running (rate of perceived effort 2-4 on 1-10 Borg Scale), followed by dynamic stretching exercises targeting the upper and lower extremities. In the final phase, running drills were performed, including three progressively increasing sprint efforts over a distance of approximately 30 meters.
Inspiratory Muscle Warm-up Protocols In addition to AWU an athletic warm-up protocol, participants performed inspiratory muscle warm-up (IMW) using the POWERbreathe® Plus Blue Medium Resistance (POWERbreathe International Ltd., Warwickshire, England UK) device at varying intensities. The IMW protocol was implemented at three different intensity levels: IW60, IW40, and IWPL. In the IW60 condition, inspiratory muscle warm-up was performed at 60% of maximal inspiratory pressure (MIP), while in IW40 and IWPL conditions, the intensity was set at 40% and 15% of MIP, respectively, with the latter serving as the sham protocolplacebo condition. Each protocol consisted of two sets of 30 repetitions.
MeasurementsTest Protocols Inspiratory and Expiratory Muscle Strength Test Maximal inspiratory pressure represents the highest negative intrathoracic pressure generated during inspiration, while MEP refers to the highest positive intrathoracic pressure produced by expiratory muscles under static conditions. These physiological parameters are commonly used for the objective assessment of respiratory muscle strength. For measurements, the Micro Medical-Carefusion Micro RPM (MicroMedical/CareFusion, Kent, UK) device, a validated assessment tool with real-time monitoring capability, was used. To prevent air leaks, participants' noses were occluded using a nasal clip during testing. For MEP measurement, participants were instructed to inhale maximally up to total lung capacity and then perform a forceful expiration through the mouthpiece. For MIP measurement, participants were instructed to exhale fully to residual volume, immediately followed by a maximal inspiratory effort. Each test was repeated at least three times, and testing was concluded when the difference between repeated measurements did not exceed 20%. The highest value was recorded as the final result. Participants were encouraged to exert maximum effort during all tests. All measurements were performed with participants in a seated position, following standardized guidelines of American Thoracic Society/European Respiratory Society .
Peak Inspiratory Flow Rate and Inhaled Volume Test Peak Inspiratory Flow Rate (PIFR) is a method used to assess respiratory muscle strength and airway resistance by measuring the maximum airflow rate (L/min) achieved during inspiration. Inhaled Volume (IV) measures the total volume of air (L) inhaled in a single breath, serving as an indicator of respiratory muscle capacity and pulmonary ventilation efficiency. A portable POWERbreathe® K5 device (POWERbreathe International Ltd., Warwickshire, England UK) was used for both assessments. Testing was conducted with participants seated, their noses occluded with a nose clip. Participants were instructed to exhale fully to residual volume, followed by a forceful maximal inspiration lasting at least one second. Each test was repeated three times, and the highest recorded value was used for analysis. Measurements of PIFR and IV were obtained simultaneously using the device's single-breath test mode.
Blood Lactate Test Blood lactate levels were measured using a portable and validated analysis device, the Lactate Scout Sport (EKF Diagnostics, Germany). All measurements were conducted according to standardized protocols to ensure accuracy and reliability. Capillary blood sampling was performed from the fingertip. Before sample collection, the skin was first cleansed and sweat was removed using an alcohol-based antiseptic, followed by rinsing with water for additional cleaning. A single-use lancet was then used to puncture the fingertip, and the first drop of blood was discarded. The subsequent drop was applied directly to the device's test strip for analysis. To prevent contamination and ensure measurement consistency, a different finger was used for each test. Additionally, the device's automatic calibration procedures were performed every 12 measurements.
Heat Rate A validated and highly accurate heart rate sensor (PolarPolar H10, Kempele, Finland) was used to measure heart rate, ensuring reliability and precision (Schaffarczyk et al., 2022) recorded in real time using the Polar Flow mobile application, which synchronizes wirelessly via Bluetooth with the sensor to provide instantaneous feedback on cardiac activity.
Determination of Sprint Time After completing the warm-up protocol, participants performed a 400-meter sprint test on a standard 400-meter outdoor tartan track (Lane 4) using their personal spiked running shoes previously used in competitions. The test was conducted using starting blocks, and at the beginning of each trial, a researcher with official sprint start officiating experience in track and field competitions gave the "Set" command. The sprint time was initiated automatically with the sound of a starting pistol connected to an optical sensor. Participants ran with maximum effort towards the finish line, where the time was stopped using optical sensors (DK-386, Turkey). Performance was recorded automatically. Participants were instructed to perform as if they were in a competitive race, but no pacing or race strategy guidance was provided. Due to the frequency of post-run measurements, each test was conducted individually to ensure accurate data collection.
Statistical analysis The normality of the distribution was evaluated with the Shapiro-Wilk test and visual assessment. The basic results are reported as mean and standard deviation. The statistical effects for running performance were evaluated by regular analysis of variance. The effects for time and the interaction between time and warm-up protocol for all other variables were analyzed using analysis of variance for repeated-measures. Mauchly's Test of Sphericity and Greenhouse-Geisser correction were used to identify and correct for the violation of sphericity. To account for multiple testing, the post-hoc Holm correction was applied, ensuring a stringent control of type I error. Effect sizes were calculated using partial eta squared (ηp²) and omega squared (ω²). The following values were suggested as small (0.01), medium (0.06) or large (0.14) effect sizes. A significance level of p < 0.05 was applied. All statistical analyses were performed using the JASP Team statistical package JASP (Amsterdam, Netherlands, version 0.17.2).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Corum Merkez
-
Çorum, Corum Merkez, Turkey, 19030
- Faculty of Sport Sciences, Hitit University.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Athletes included in the study had previous competition experience in 400-meter track events on national level, no history of respiratory diseases, were non-smokers, and had not experienced any sports injuries in the past five months. All the participants were healthy and medically cleared to take part in competitive track and field.
Exclusion Criteria:
The exclusion criteria were: using any ongoing medication or using performance-enhancing substances, and any acute or chronic illness.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: IW-SHAM
Inspiratory Muscle Warm-up Protocols In addition to athletic warm-up an athletic warm-up protocol, participants performed inspiratory muscle warm-up (IMW) using the POWERbreathe® Plus Blue Medium Resistance (POWERbreathe International Ltd., Warwickshire, England UK).
In the sham arm, inspiratory muscle warm-up was performed at 15% of maximal inspiratory pressure (MIP).
Each protocol consisted of two sets of 30 repetitions (Marostegan et al., 2022; Demirkan et al., 2025).
|
In addition to athletic warm-up an athletic warm-up protocol, participants performed inspiratory muscle warm-up (IMW) using the POWERbreathe® Plus Blue Medium Resistance (POWERbreathe International Ltd., Warwickshire, England UK).
In the sham arm, inspiratory muscle warm-up was performed at 15% of maximal inspiratory pressure (MIP).
Each protocol consisted of two sets of 30 repetitions (Marostegan et al., 2022; Demirkan et al., 2025).
|
|
Other: Inspiratory Warm-Up 40% MIP
In addition to athletic warm-up an athletic warm-up protocol, participants performed inspiratory muscle warm-up (IMW) using the POWERbreathe® Plus Blue Medium Resistance (POWERbreathe International Ltd., Warwickshire, England UK).
In the sham arm, inspiratory muscle warm-up was performed at 40% of maximal inspiratory pressure (MIP).
Each protocol consisted of two sets of 30 repetitions (Marostegan et al., 2022; Demirkan et al., 2025).
|
Inspiratory Muscle Warm-up Protocols In addition to athletic warm-up an athletic warm-up protocol, participants performed inspiratory muscle warm-up (IMW) using the POWERbreathe® Plus Blue Medium Resistance (POWERbreathe International Ltd., Warwickshire, England UK).
In the IW40 arm, inspiratory muscle warm-up was performed at 40% of maximal inspiratory pressure (MIP).
Each protocol consisted of two sets of 30 repetitions (Marostegan et al., 2022; Demirkan et al., 2025).
|
|
Other: Inspiratory Warm-Up 60% MIP
In addition to athletic warm-up an athletic warm-up protocol, participants performed inspiratory muscle warm-up (IMW) using the POWERbreathe® Plus Blue Medium Resistance (POWERbreathe International Ltd., Warwickshire, England UK).
In the sham arm, inspiratory muscle warm-up was performed at 60% of maximal inspiratory pressure (MIP).
Each protocol consisted of two sets of 30 repetitions (Marostegan et al., 2022; Demirkan et al., 2025).
|
Inspiratory Muscle Warm-up Protocols In addition to athletic warm-up an athletic warm-up protocol, participants performed inspiratory muscle warm-up (IMW) using the POWERbreathe® Plus Blue Medium Resistance (POWERbreathe International Ltd., Warwickshire, England UK).
In the IW60 arm, inspiratory muscle warm-up was performed at 60% of maximal inspiratory pressure (MIP).
Each protocol consisted of two sets of 30 repetitions (Marostegan et al., 2022; Demirkan et al., 2025).
|
|
Other: Athletic Warm-up Only
The athletic warm-up (AWU) consisted of 15 minutes of low-intensity running (rate of perceived effort 2-4 on 1-10 Borg Scale), followed by dynamic stretching exercises targeting the upper and lower extremities.
In the final phase, running drills were performed, including three progressively increasing sprint efforts over a distance of approximately 30 meters.
|
In addition to athletic warm-up an athletic warm-up protocol, participants performed inspiratory muscle warm-up (IMW) using the POWERbreathe® Plus Blue Medium Resistance (POWERbreathe International Ltd., Warwickshire, England UK).
In the sham arm, inspiratory muscle warm-up was performed at 15% of maximal inspiratory pressure (MIP).
Each protocol consisted of two sets of 30 repetitions (Marostegan et al., 2022; Demirkan et al., 2025).
Inspiratory Muscle Warm-up Protocols In addition to athletic warm-up an athletic warm-up protocol, participants performed inspiratory muscle warm-up (IMW) using the POWERbreathe® Plus Blue Medium Resistance (POWERbreathe International Ltd., Warwickshire, England UK).
In the IW40 arm, inspiratory muscle warm-up was performed at 40% of maximal inspiratory pressure (MIP).
Each protocol consisted of two sets of 30 repetitions (Marostegan et al., 2022; Demirkan et al., 2025).
Inspiratory Muscle Warm-up Protocols In addition to athletic warm-up an athletic warm-up protocol, participants performed inspiratory muscle warm-up (IMW) using the POWERbreathe® Plus Blue Medium Resistance (POWERbreathe International Ltd., Warwickshire, England UK).
In the IW60 arm, inspiratory muscle warm-up was performed at 60% of maximal inspiratory pressure (MIP).
Each protocol consisted of two sets of 30 repetitions (Marostegan et al., 2022; Demirkan et al., 2025).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Running performance
Time Frame: 4 weeks
|
After completing the warm-up protocol, participants performed a 400-meter sprint test on a standard 400-meter outdoor tartan track (Lane 4) using their personal spiked running shoes previously used in competitions.
The test was conducted using starting blocks, and at the beginning of each trial, a researcher with official sprint start officiating experience in track and field competitions gave the "Set" command.
The sprint time was initiated automatically with the sound of a starting pistol connected to an optical sensor.
Participants ran with maximum effort towards the finish line, where the time was stopped using optical sensors (DK-386, Turkey).
Performance was recorded automatically.
Participants were instructed to perform as if they were in a competitive race, but no pacing or race strategy guidance was provided.
Due to the frequency of post-run measurements, each test was conducted individually to ensure accurate data collection.
|
4 weeks
|
|
Maximal Pressures
Time Frame: 4 weeks
|
Maximal inspiratory pressure represents the highest negative intrathoracic pressure generated during inspiration, while MEP refers to the highest positive intrathoracic pressure produced by expiratory muscles under static conditions.
These physiological parameters are commonly used for the objective assessment of respiratory muscle strength (Gómez-Albareda et al., 2023; Evans & Whitelaw, 2009).
For measurements, the Micro Medical-Carefusion Micro RPM (MicroMedical/CareFusion, Kent, UK) device, a validated assessment tool with real-time monitoring capability, was used (Erail & Mayda, 2023).
To prevent air leaks, participants' noses were occluded using a nasal clip during testing.
All measurements were performed with participants in a seated position, following standardized guidelines (American Thoracic Society/European Respiratory Society, 2002).
|
4 weeks
|
|
Peak Inspiratory Flow Rate
Time Frame: 4 weeks
|
Peak Inspiratory Flow Rate (PIFR) is a method used to assess respiratory muscle strength and airway resistance by measuring the maximum airflow rate (L/min) achieved during inspiration (Ghosh et al., 2017).
A portable POWERbreathe® K5 device (POWERbreathe International Ltd., Warwickshire, England UK) was used.
Testing was conducted with participants seated, their noses occluded with a nose clip (Kowalski & Klusiewicz, 2023).
Participants were instructed to exhale fully to residual volume (RV), followed by a forceful maximal inspiration lasting at least one second.
Each test was repeated three times, and the highest recorded value was used for analysis.
Measurements of PIFR were obtained simultaneously using the device's single-breath test mode (Demirkan et al., 2025).
|
4 weeks
|
|
Peak Inspiratory Flow Rate
Time Frame: 4 weeks
|
Peak Inspiratory Flow Rate (PIFR) is a method used to assess respiratory muscle strength and airway resistance by measuring the maximum airflow rate (L/min) achieved during inspiration (Ghosh et al., 2017).
A portable POWERbreathe® K5 device (POWERbreathe International Ltd., Warwickshire, England UK) was used for both assessments.
It was conducted with participants seated, their noses occluded with a nose clip (Kowalski & Klusiewicz, 2023).
Participants were instructed to exhale fully to residual volume (RV), followed by a forceful maximal inspiration lasting at least one second.
Each test was repeated three times, and the highest recorded value was used for analysis.
Measurements of PIFR and IV were obtained simultaneously using the device's single-breath test mode (Demirkan et al., 2025).
|
4 weeks
|
|
Inhaled Volume
Time Frame: 4 weeks
|
(IV) measures the total volume of air (L) inhaled in a single breath, serving as an indicator of respiratory muscle capacity and pulmonary ventilation efficiency (Krause-Sorio et al., 2021).
A portable POWERbreathe® K5 device (POWERbreathe International Ltd., Warwickshire, England UK) was used for the assessment.
Testing was conducted with participants seated, their noses occluded with a nose clip (Kowalski & Klusiewicz, 2023).
Participants were instructed to exhale fully to residual volume (RV), followed by a forceful maximal inspiration lasting at least one second.
Each test was repeated three times, and the highest recorded value was used for analysis.
Measurements of IV were obtained simultaneously using the device's single-breath test mode (Demirkan et al., 2025).
|
4 weeks
|
|
Blood lactate
Time Frame: 4 weeks
|
Blood lactate levels were measured using a portable and validated analysis device, the Lactate Scout Sport (EKF Diagnostics, Germany).
All measurements were conducted according to standardized protocols to ensure accuracy and reliability.
Capillary blood sampling was performed from the fingertip.
Before sample collection, the skin was first cleansed and sweat was removed using an alcohol-based antiseptic, followed by rinsing with water for additional cleaning.
A single-use lancet was then used to puncture the fingertip, and the first drop of blood was discarded.
The subsequent drop was applied directly to the device's test strip for analysis (Zhong et al., 2025).
To prevent contamination and ensure measurement consistency, a different finger was used for each test.
Additionally, the device's automatic calibration procedures were performed every 12 measurements.
|
4 weeks
|
|
Heart rate
Time Frame: 4 weeks
|
A validated and highly accurate heart rate sensor (PolarPolar H10, Kempele, Finland) was used to measure heart rate, ensuring reliability and precision (Schaffarczyk et al., 2022).
Heart rate data were continuously monitored and recorded in real time using the Polar Flow mobile application, which synchronizes wirelessly via Bluetooth with the sensor to provide instantaneous feedback on cardiac activity.
|
4 weeks
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HI:2024-148
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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