Healthy ParticipantsIMW-AENCT07445269
ACUTE EFFECTS OF INSPIRATORY MUSCLE WARM-UP ON INSPIRATORY MUSCLE STRENGTH DURING AEROBIC AND ANAEROBIC EXERCISE IN ATHLETES
A study testing Inspiratory Muscle Warm-Up (40% MIP) in people with Healthy Participants, run by Hitit University at 1 site in Turkey (Türkiye).
Trial summary
Inspiratory muscle warm-up (IMW) is a specific pre-exercise breathing intervention designed to prepare the respiratory muscles before physical activity and potentially enhance exercise performance. Read more about this study
- Who is it for?
- Ages 14 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Inspiratory Muscle Warm-Up (40% MIP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Feb 2026to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 14 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age between 14 and 30 years.
- Regular participation in organized sports training for at least 4 years.
- Engaged in predominantly aerobic or anaerobic sports disciplines.
- Training frequency of at least 3 sessions per week.
- No known cardiopulmonary disease affecting respiratory function.
- Ability to safely perform maximal effort treadmill exercise.
Show all 9Show fewer
- No respiratory illness within the last 12 weeks.
- Willingness to comply with study procedures.
- Provision of written informed consent (and parental consent for minors where applicable).
Who cannot join
- History of asthma, chronic obstructive pulmonary disease (COPD), or other respiratory disorders.
- Age below 14 years or above 30 years.
- Orthopedic injury or condition limiting running ability.
- Participation in inspiratory muscle training within the last 12 months.
- Use of medications affecting respiratory or cardiovascular function.
- Active smoking.
- Failure to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Hitit University Faculty of Sport Sciences, Exercise Physiology Laboratory
Çorum, 19030
About this study
Inspiratory muscle warm-up (IMW) is a specific pre-exercise breathing intervention designed to prepare the respiratory muscles before physical activity and potentially enhance exercise performance. Previous research suggests that IMW may acutely improve inspiratory muscle function; however, the duration of these effects during exercise and their responses under different exercise intensities remain unclear. Furthermore, placebo-controlled comparisons are limited in the current literature.
The purpose of this study is to investigate the acute effects of inspiratory muscle warm-up on inspiratory muscle strength during aerobic and anaerobic exercise in trained athletes. The study will compare three experimental conditions: a standardized inspiratory muscle warm-up protocol, a placebo breathing warm-up, and a control condition without respiratory warm-up.
Read more
In this repeated-measures interventional study, trained athletes aged 14-30 years will complete three experimental sessions in randomized order. The active intervention consists of inspiratory muscle warm-up performed at 40% of maximal inspiratory pressure (MIP). The placebo condition includes a low-resistance breathing protocol designed to mimic the intervention without providing a meaningful training stimulus. The control condition involves exercise performed without respiratory warm-up.
Participants will perform treadmill exercise at intensity levels representing aerobic and anaerobic workloads, defined according to percentage of maximal heart rate. Inspiratory muscle strength (MIP) will be assessed at baseline, immediately after the warm-up protocols, and periodically during exercise to evaluate time-dependent changes.
The primary objective is to determine how long the acute increase in inspiratory muscle strength is maintained during exercise and to compare responses between aerobic and anaerobic athletes across the three conditions. The findings may provide evidence-based guidance for integrating respiratory muscle warm-up strategies into sport-specific preparation routines.
Read the detailed description
Inspiratory muscle warm-up (IMW) has emerged as a non-pharmacological pre-exercise strategy aimed at enhancing respiratory muscle readiness prior to physical activity. The inspiratory muscles, particularly the diaphragm and accessory respiratory muscles, play a critical role in meeting increased ventilatory demands during exercise. Acute respiratory muscle fatigue has been associated with reduced performance through mechanisms such as altered ventilatory efficiency and activation of the respiratory muscle metaboreflex, which may redistribute blood flow away from locomotor muscles. While previous studies have reported beneficial acute effects of IMW on respiratory and performance parameters, the temporal characteristics of these effects during ongoing exercise remain insufficiently understood.
Existing research has primarily focused on pre- and post-intervention comparisons, often evaluating inspiratory muscle strength immediately following IMW without assessing how long these acute improvements persist during exercise. Furthermore, the influence of exercise intensity domains and athlete specialization (aerobic vs. anaerobic disciplines) on the duration of IMW-induced effects has not been systematically investigated. Another limitation of prior studies is the limited use of placebo-controlled designs, which are important for distinguishing physiological effects from expectancy or psychological influences associated with warm-up interventions.
The present study is designed as a repeated-measures interventional investigation to evaluate the acute time course of inspiratory muscle strength responses following inspiratory muscle warm-up under different exercise conditions. Each participant will complete three experimental sessions, including: (1) an active inspiratory muscle warm-up protocol performed at a standardized relative intensity, (2) a placebo breathing warm-up designed to mimic the intervention without providing a meaningful physiological load, and (3) a control condition without respiratory warm-up. The order of conditions will be counterbalanced to minimize order effects.
Exercise trials will involve treadmill running performed at predefined intensity domains representing aerobic and anaerobic workloads based on individual maximal heart rate. Inspiratory muscle strength will be measured repeatedly throughout exercise to identify the time-dependent decline relative to baseline and post-warm-up levels. This design allows examination of both immediate and sustained effects of respiratory muscle preparation strategies.
By comparing responses between athletes from predominantly aerobic and anaerobic sports backgrounds, the study seeks to explore whether differences in energy system utilization, muscle fiber composition, and ventilatory demands influence the effectiveness and duration of inspiratory muscle warm-up. The findings may contribute to a more precise understanding of respiratory muscle preparation and support evidence-based integration of breathing-specific warm-up strategies into athletic training and competition routines.
- Conditions
- Healthy Participants
- Being tested
- Inspiratory Muscle Warm-Up (40% MIP), Placebo Breathing Warm-Up (15% MIP)
- Keywords
- Inspiratory Muscle Warm-Up, Inspiratory Muscle Strength, Maximal Inspiratory Pressure, Respiratory Muscle Performance, Aerobic Exercise, Anaerobic Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Muscle Warm-Up (40% MIP)Behavioural
A standardized inspiratory muscle warm-up performed using a breathing resistance device set at 40% of maximal inspiratory pressure (MIP). Participants perform resisted inspiratory efforts prior to exercise to acutely activate respiratory muscles.
Placebo Breathing Warm-Up (15% MIP)Behavioural
A sham breathing warm-up performed using the same device and breathing pattern as the active intervention but with resistance set at 15% of maximal inspiratory pressure (MIP), intended to minimize physiological loading while maintaining procedural similarity.
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory Muscle Warm-Up (40% MIP) | Experimental | Participants perform a standardized inspiratory muscle warm-up using a breathing resistance device set at 40% of maximal inspiratory pressure (MIP) prior to exercise testing. The protocol consists of resisted inspiratory efforts designed to acutely activate the respiratory muscles before aerobic or anaerobic exercise. Receives: Behavioral: Inspiratory Muscle Warm-Up (40% MIP) |
| Placebo Breathing Warm-Up (15% MIP) | Placebo comparator | Participants perform a placebo breathing warm-up using the same device and procedures as the active intervention, but with resistance set at 15% of maximal inspiratory pressure (MIP). This low-resistance protocol is intended to mimic the intervention while minimizing meaningful physiological loading. Receives: Behavioral: Placebo Breathing Warm-Up (15% MIP) |
| Control (No Respiratory Warm-Up) | No intervention | Participants complete the exercise protocol without any inspiratory muscle warm-up prior to testing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Decline in Maximal Inspiratory Pressure (MIP) During Exercise
Time (minutes) until maximal inspiratory pressure (MIP) decreases below baseline or post-warm-up levels during aerobic and anaerobic exercise following inspiratory muscle warm-up, placebo breathing warm-up, or control conditions.
Measured: From exercise onset until the time of MIP decline during a single acute exercise testing session (up to 30 minutes).
Secondary outcomes (2)
Acute Change in Maximal Inspiratory Pressure After Warm-Up
Difference between baseline MIP and immediate post-warm-up MIP across experimental conditions.
Measured: From exercise onset until MIP declines below baseline or post-warm-up values, assessed at minutes 2, 4, 6, 8, and 10, then at minutes 14, 18, 22, 26, and 30 (up to 30 minutes).
Repeated MIP Measurements During Exercise
Periodic maximal inspiratory pressure values measured at predefined intervals during treadmill exercise.
Measured: Every 2 minutes during exercise.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start25 Feb 2026 (estimated)
- Primary completion25 Mar 2026 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will complete three conditions (inspiratory muscle warm-up, placebo breathing warm-up, and control with no respiratory warm-up) in a randomized crossover design. All participants will undergo each condition in separate sessions, with the order counterbalanced and sessions separated by adequate washout periods to minimize carryover effects. Inspiratory muscle strength will be assessed repeatedly within each session to characterize the time course of acute responses during aerobic and anaerobic exercise workloads.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hitit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet İsmail TOSUN, Hitit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07445269
- Sponsor's protocol ID
- 2025-39
- Acronym
- IMW-AE
- Status last verified
- Feb 2026
- First submitted
- 18 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the results reported in publications, including maximal inspiratory pressure (MIP) measurements, demographic variables, exercise responses, and related outcome variables, will be made available upon reasonable request. Data will be shared after publication of the main study results and in accordance with institutional ethics approval and applicable data protection regulations. A data dictionary and relevant methodological documentation will be provided to allow appropriate interpretation of the dataset. Requests for data access will be evaluated by the principal investigator to ensure scientific validity and compliance with ethical standards.
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACUTE EFFECTS OF INSPIRATORY MUSCLE WARM-UP ON INSPIRATORY MUSCLE STRENGTH DURING AEROBIC AND ANAEROBIC EXERCISE IN ATHLETES
- ClinicalTrials.gov ID
- NCT07445269
- Acronym / sponsor ID
- IMW-AE / 2025-39
- Conditions
- Healthy Participants
- Keywords
- Inspiratory Muscle Warm-Up, Inspiratory Muscle Strength, Maximal Inspiratory Pressure, Respiratory Muscle Performance, Aerobic Exercise, Anaerobic Exercise
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Hitit UniversityUniversity, hospital or other
- Study start
- 25 Feb 2026 (estimated)
- Primary completion
- 25 Mar 2026 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 3 Mar 2026 (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.
Inspiratory muscle warm-up (IMW) is a specific pre-exercise breathing intervention designed to prepare the respiratory muscles before physical activity and potentially enhance exercise performance. Previous research suggests that IMW may acutely improve inspiratory muscle function; however, the duration of these effects during exercise and their responses under different exercise intensities remain unclear. Furthermore, placebo-controlled comparisons are limited in the current literature.
The purpose of this study is to investigate the acute effects of inspiratory muscle warm-up on inspiratory muscle strength during aerobic and anaerobic exercise in trained athletes. The study will compare three experimental conditions: a standardized inspiratory muscle warm-up protocol, a placebo breathing warm-up, and a control condition without respiratory warm-up.
In this repeated-measures interventional study, trained athletes aged 14-30 years will complete three experimental sessions in randomized order. The active intervention consists of inspiratory muscle warm-up performed at 40% of maximal inspiratory pressure (MIP). The placebo condition includes a low-resistance breathing protocol designed to mimic the intervention without providing a meaningful training stimulus. The control condition involves exercise performed without respiratory warm-up.
Participants will perform treadmill exercise at intensity levels representing aerobic and anaerobic workloads, defined according to percentage of maximal heart rate. Inspiratory muscle strength (MIP) will be assessed at baseline, immediately after the warm-up protocols, and periodically during exercise to evaluate time-dependent changes.
The primary objective is to determine how long the acute increase in inspiratory muscle strength is maintained during exercise and to compare responses between aerobic and anaerobic athletes across the three conditions. The findings may provide evidence-based guidance for integrating respiratory muscle warm-up strategies into sport-specific preparation routines.
Detailed description
Inspiratory muscle warm-up (IMW) has emerged as a non-pharmacological pre-exercise strategy aimed at enhancing respiratory muscle readiness prior to physical activity. The inspiratory muscles, particularly the diaphragm and accessory respiratory muscles, play a critical role in meeting increased ventilatory demands during exercise. Acute respiratory muscle fatigue has been associated with reduced performance through mechanisms such as altered ventilatory efficiency and activation of the respiratory muscle metaboreflex, which may redistribute blood flow away from locomotor muscles. While previous studies have reported beneficial acute effects of IMW on respiratory and performance parameters, the temporal characteristics of these effects during ongoing exercise remain insufficiently understood.
Existing research has primarily focused on pre- and post-intervention comparisons, often evaluating inspiratory muscle strength immediately following IMW without assessing how long these acute improvements persist during exercise. Furthermore, the influence of exercise intensity domains and athlete specialization (aerobic vs. anaerobic disciplines) on the duration of IMW-induced effects has not been systematically investigated. Another limitation of prior studies is the limited use of placebo-controlled designs, which are important for distinguishing physiological effects from expectancy or psychological influences associated with warm-up interventions.
The present study is designed as a repeated-measures interventional investigation to evaluate the acute time course of inspiratory muscle strength responses following inspiratory muscle warm-up under different exercise conditions. Each participant will complete three experimental sessions, including: (1) an active inspiratory muscle warm-up protocol performed at a standardized relative intensity, (2) a placebo breathing warm-up designed to mimic the intervention without providing a meaningful physiological load, and (3) a control condition without respiratory warm-up. The order of conditions will be counterbalanced to minimize order effects.
Exercise trials will involve treadmill running performed at predefined intensity domains representing aerobic and anaerobic workloads based on individual maximal heart rate. Inspiratory muscle strength will be measured repeatedly throughout exercise to identify the time-dependent decline relative to baseline and post-warm-up levels. This design allows examination of both immediate and sustained effects of respiratory muscle preparation strategies.
By comparing responses between athletes from predominantly aerobic and anaerobic sports backgrounds, the study seeks to explore whether differences in energy system utilization, muscle fiber composition, and ventilatory demands influence the effectiveness and duration of inspiratory muscle warm-up. The findings may contribute to a more precise understanding of respiratory muscle preparation and support evidence-based integration of breathing-specific warm-up strategies into athletic training and competition routines.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will complete three conditions (inspiratory muscle warm-up, placebo breathing warm-up, and control with no respiratory warm-up) in a randomized crossover design. All participants will undergo each condition in separate sessions, with the order counterbalanced and sessions separated by adequate washout periods to minimize carryover effects. Inspiratory muscle strength will be assessed repeatedly within each session to characterize the time course of acute responses during aerobic and anaerobic exercise workloads.
| Arm | Type | Receives |
|---|---|---|
| Inspiratory Muscle Warm-Up (40% MIP) | Experimental | Behavioral: Inspiratory Muscle Warm-Up (40% MIP)Participants perform a standardized inspiratory muscle warm-up using a breathing resistance device set at 40% of maximal inspiratory pressure (MIP) prior to exercise testing. The protocol consists of resisted inspiratory efforts designed to acutely activate the respiratory muscles before aerobic or anaerobic exercise. |
| Placebo Breathing Warm-Up (15% MIP) | Placebo comparator | Behavioral: Placebo Breathing Warm-Up (15% MIP)Participants perform a placebo breathing warm-up using the same device and procedures as the active intervention, but with resistance set at 15% of maximal inspiratory pressure (MIP). This low-resistance protocol is intended to mimic the intervention while minimizing meaningful physiological loading. |
| Control (No Respiratory Warm-Up) | No intervention | –Participants complete the exercise protocol without any inspiratory muscle warm-up prior to testing. |
Who may qualify
- Ages
- 14 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Age between 14 and 30 years.
- Regular participation in organized sports training for at least 4 years.
- Engaged in predominantly aerobic or anaerobic sports disciplines.
- Training frequency of at least 3 sessions per week.
- No known cardiopulmonary disease affecting respiratory function.
Key exclusion criteria (7 listed)
- History of asthma, chronic obstructive pulmonary disease (COPD), or other respiratory disorders.
- Age below 14 years or above 30 years.
- Orthopedic injury or condition limiting running ability.
- Participation in inspiratory muscle training within the last 12 months.
- Use of medications affecting respiratory or cardiovascular function.
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 |
|---|---|---|
| Inspiratory Muscle Warm-Up (40% MIP)A standardized inspiratory muscle warm-up performed using a breathing resistance device set at 40% of maximal inspiratory pressure (MIP). Participants perform resisted inspiratory efforts prior to exercise to acutely activate respiratory muscles. | Behavioural | Inspiratory Muscle Warm-Up (40% MIP) |
| Placebo Breathing Warm-Up (15% MIP)A sham breathing warm-up performed using the same device and breathing pattern as the active intervention but with resistance set at 15% of maximal inspiratory pressure (MIP), intended to minimize physiological loading while maintaining procedural similarity. | Behavioural | Placebo Breathing Warm-Up (15% MIP) |
Primary outcome
Time to Decline in Maximal Inspiratory Pressure (MIP) During Exercise
Time frame: From exercise onset until the time of MIP decline during a single acute exercise testing session (up to 30 minutes).
Time (minutes) until maximal inspiratory pressure (MIP) decreases below baseline or post-warm-up levels during aerobic and anaerobic exercise following inspiratory muscle warm-up, placebo breathing warm-up, or control conditions.
2 secondary outcomes
Acute Change in Maximal Inspiratory Pressure After Warm-Up
Time frame: From exercise onset until MIP declines below baseline or post-warm-up values, assessed at minutes 2, 4, 6, 8, and 10, then at minutes 14, 18, 22, 26, and 30 (up to 30 minutes).
Repeated MIP Measurements During Exercise
Time frame: Every 2 minutes during exercise.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the results reported in publications, including maximal inspiratory pressure (MIP) measurements, demographic variables, exercise responses, and related outcome variables, will be made available upon reasonable request. Data will be shared after publication of the main study results and in accordance with institutional ethics approval and applicable data protection regulations. A data dictionary and relevant methodological documentation will be provided to allow appropriate interpretation of the dataset. Requests for data access will be evaluated by the principal investigator to ensure scientific validity and compliance with ethical standards.
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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.
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 Inspiratory Muscle Warm-Up (40% MIP) in people with Healthy Participants, run by Hitit 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 9 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 3 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Time to Decline in Maximal Inspiratory Pressure (MIP) During Exercise (time frame: From exercise onset until the time of MIP decline during a single acute exercise testing session (up to 30 minutes).). 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 3 Mar 2026.