AthleteNCT06751511
The Effect of Inspiratory Muscle Warm-up on Decreased Diffusing Capacity for Carbon Monoxide After Maximal Exercise in Athletes
A study testing General warm-up and Inspiratory muscle warm-up (%40 IMW) in people with Athlete, run by Emre Karaduman.
Trial summary
This study aims to examine the effects of inspiratory muscle warm-up (IMW) on the gas exchange capacity of the lungs (DLCO) and its potential contribution to recovery and athletic performance in elite athletes from various disciplines. Read more about this study
- Who is it for?
- Ages 18 to 24 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Athlete
- What is being tested?
- General warm-up and Inspiratory muscle warm-up (%40 IMW)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2025to 30 Jan 2025
- 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 18 to 24 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18-24 years.
- A training history of at least six years.
- Regular training frequency of at least four sessions per week.
Who cannot join
- History of smoking.
- History of physical disability or acute respiratory or cardiovascular disease within the past three months.
- Diagnosis of SARS-CoV-2 within the past three months.
- Pulmonary function measurements outside the normal clinical range (≤ 80%).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Inspiratory Muscle Warm-up on Decreased Diffusing Capacity for Carbon Monoxide After Maximal Exercise in Athletes: a Randomized, Placebo-controlled, Double-blind and Crossover Study
This study aims to examine the effects of inspiratory muscle warm-up (IMW) on the gas exchange capacity of the lungs (DLCO) and its potential contribution to recovery and athletic performance in elite athletes from various disciplines. The study hypothesizes that the decline in respiratory muscle capacity following high-intensity exercise, which negatively affects ventilation, diffusion, and oxygen transport, may be ameliorated through specific IMW protocol. A placebo-controlled, randomized, crossover, and double-blind design will be utilized, involving 28 elite male athletes from endurance, power, skill-based, and mixed disciplines.
Participants will complete three warm-up protocols: General Warm-up (GW), General Warm-up combined with IMW at 40% resistance intensity (GW+IMW40%), and a placebo condition (GW+IMWplacebo). Measurements will include respiratory muscle strength, DLCO (assessed at post-2, 30, 60, 90, and 120 minutes), respiratory function, and cardiorespiratory parameters during maximal exercise. This study is unique as it aims to detail the micro-level effects of IMW on pulmonary diffusion mechanisms and performance outcomes, providing novel insights into the ameliorative effects of IMW on respiratory function post-exercise. Additionally, it seeks to expand understanding of the mechanistic basis of IMW's benefits on both pulmonary diffusion capacity and athletic performance.
Read the detailed description
STUDY DESIGN This study will employ a placebo-controlled, randomized, crossover, and double-blind research design to evaluate the effects of three warm-up conditions: Control, Placebo 15%, and IMW 40%. Athletes will be randomly assigned to the conditions using a crossover approach, ensuring that all participants will experience each protocol on separate days.
The warm-up protocols will include:
General Warm-up (Control): A standard warm-up without resistance. IMW 40%: A general warm-up combined with inspiratory muscle warm-up at 40% resistance intensity.
Placebo 15%: A general warm-up combined with inspiratory muscle warm-up (placebo) at 15% resistance intensity.
Blinding will be maintained for both participants and researchers. Participants will be informed that the study aims to investigate various warm-up types, while the true purpose will remain concealed. This design will ensure reliability and minimize bias in the data to be collected.
- Conditions
- Athlete
- Being tested
- General warm-up, Inspiratory muscle warm-up (Placebo - %15), Inspiratory muscle warm-up (%40 IMW)
- Keywords
- warm-up, inspiratory muscle warm-up, respiratory muscle warm-up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General warm-upOther
The General Warm-up (Control) protocol will consist of activities such as running and dynamic, active, and passive movements, adapted to suit the varied sports disciplines included in the study. These exercises will align with the principles of elevation, activation, and mobilization, aiming to enhance mobility across key muscle groups, from the arms and shoulders to the lower back and legs. Each session will include clear demonstrations to ensure proper technique and pacing, with participants performing a standardized number of repetitions. Researchers will supervise participants closely to verify accurate form and consistent execution during the intervention.
Inspiratory muscle warm-up (Placebo - %15)Other
The placebo inspiratory muscle warm-up protocol will utilize the POWERbreathe® device at 15% of maximal inspiratory pressure (MIP). This placebo protocol will consist of two sets of 30 breaths, separated by a 60-second rest interval, with participants seated and wearing a nose clip. Proper technique will be taught during a prior familiarization session, and participants will be closely monitored during testing to ensure accurate execution. This protocol is designed to function as a placebo, effectively concealing the study's true objective to improve data validity and reliability.
Inspiratory muscle warm-up (%40 IMW)Other
This study will implement a respiratory muscle warm-up protocol at 40% of maximal inspiratory pressure (MIP) using the POWERbreathe® device, as this intensity is considered optimal for effectively stimulating respiratory muscles. The protocol will consist of two sets of 30 breaths, with a 60-second rest period between sets, conducted while participants are seated and wearing a nose clip. Training for proper technique will be provided during the familiarization session, and participants will be closely monitored throughout the tests to ensure correct and consistent execution.
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Participants only performed a general warm-up exercise. Receives: Other: General warm-up |
| IWM %15 Placebo | Placebo comparator | In addition to the general warm-up, the participants performed IMW at 15% resistance intensity. Receives: Other: Inspiratory muscle warm-up (Placebo - %15) |
| IWM %40 Intervention | Active comparator | In addition to the general warm-up, participants performed IMW at 40% resistance intensity. Receives: Other: Inspiratory muscle warm-up (%40 IMW) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung Carbon Monoxide Diffusion Capacity (DLCO)
DLCO will be measured using the single breath-hold method with a Quark PFT gas analyzer, following ATS/ERS standards. Each test involves inhalation of a gas mixture (0.3% CO, 0.3% CH4, and dry air), breath-holding for 10±2 seconds, and exhalation. Subjects will undergo DLCO tests at baseline, following the warm-up protocols, and at both the start and conclusion of VO2max testing. Additional measurements will be conducted at 2, 30, 60, 90, and 120 minutes post-VO2max during each laboratory visit.
Measured: Pre intervention and immediately post intervention
Pulmonary Function (FVC)
Forced Vital Capacity (FVC) will be assessed using the Quark PFT device according to ATS/ERS guidelines. Subjects will perform the FVC maneuver while seated, with disposable mouthpieces and a nose clip to ensure accurate recordings. The FVC maneuver will involve a maximal inhalation followed by a rapid and forceful exhalation into the spirometer until no more air can be expelled. Subjects will be encouraged to maintain consistent effort throughout the maneuver to ensure reliable and reproducible results.
Measured: Pre intervention and immediately post intervention
Pulmonary Function (SVC)
Slow Vital Capacity (SVC) will be assessed using the Quark PFT device according to ATS/ERS guidelines. Subjects will perform the SVC maneuver while seated, with disposable mouthpieces and a nose clip to ensure accurate recordings. The SVC maneuver will start with a full, deep inhalation. This will be followed by a slow and controlled exhalation at a steady pace until the lungs are completely emptied. The maneuver will provide measurements reflecting lung volumes under non-forced conditions.
Measured: Pre intervention and immediately post intervention
Pulmonary Functions (MVV)
Maximum Voluntary Ventilation (MVV) will be assessed using the Quark PFT device according to ATS/ERS guidelines. Subjects will perform the MVV maneuver while seated, with disposable mouthpieces and a nose clip to ensure accurate recordings. The MVV maneuver will evaluate the maximum amount of air a subject can inhale and exhale in a specific timeframe, typically 12 seconds. Subjects will be instructed to breathe as quickly and deeply as possible during the maneuver. Proper coaching will be provided to help maintain maximal effort while avoiding hyperventilation-related discomfort.
Measured: Pre intervention and immediately post intervention
Respiratory Muscle Strength
Respiratory muscle strength will be measured using the Pony FX MIP/MEP device following ERS guidelines. For maximal respiratory pressures, subjects will exhale maximally, followed by a maximal inspiration against a closed valve (and the opposite maneuver). At least three trials with less than 5% variability will be averaged to determine the final values.
Measured: Pre intervention and immediately post intervention
Bicycle ergometer and Maximal Aerobic Capacity (VO2max)
The test will begin at a workload of 50 (Watt) and will progress by increasing the workload by 25 (Watt) every two minutes. Throughout the test, the pedaling speed (rhythm) will be continuously monitored on the bicycle display, and participants will be instructed to maintain a steady pace within an average range of ≥60 (±5) rpm. Despite strong verbal encouragement provided during the test, it will be terminated if a participant spends more than 10 seconds below the 55 rpm pedal rhythm and decides they cannot continue further (voluntary exhaustion). After completing the test, participants will continue pedaling at a workload of 20 (Watt) for approximately 2 minutes for active recovery. Each test will be initiated in accordance with the workload optimization and adjustments to bike fit (saddle, handlebar height, and position) performed during the first visit. Cardiopulmonary data will be obtained using a breath-by-breath Quark CPET metabolic system (Mixing chamber system) (COSMED).
Measured: Pre intervention and immediately post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study start15 Jan 2025 (estimated)
- Primary completion15 Jan 2025 (estimated)
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AthleteStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emre Karaduman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Emre Karaduman, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06751511
- Sponsor's protocol ID
- 2023/473
- Status last verified
- Dec 2024
- First submitted
- 20 Dec 2024
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Inspiratory Muscle Warm-up on Decreased Diffusing Capacity for Carbon Monoxide After Maximal Exercise in Athletes: a Randomized, Placebo-controlled, Double-blind and Crossover Study
- ClinicalTrials.gov ID
- NCT06751511
- Acronym / sponsor ID
- 2023/473
- Conditions
- Athlete
- Keywords
- warm-up, inspiratory muscle warm-up, respiratory muscle warm-up
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Emre KaradumanUniversity, hospital or other
- Study start
- 15 Jan 2025 (estimated)
- Primary completion
- 15 Jan 2025 (estimated)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 30 Dec 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.
This study aims to examine the effects of inspiratory muscle warm-up (IMW) on the gas exchange capacity of the lungs (DLCO) and its potential contribution to recovery and athletic performance in elite athletes from various disciplines. The study hypothesizes that the decline in respiratory muscle capacity following high-intensity exercise, which negatively affects ventilation, diffusion, and oxygen transport, may be ameliorated through specific IMW protocol. A placebo-controlled, randomized, crossover, and double-blind design will be utilized, involving 28 elite male athletes from endurance, power, skill-based, and mixed disciplines.
Participants will complete three warm-up protocols: General Warm-up (GW), General Warm-up combined with IMW at 40% resistance intensity (GW+IMW40%), and a placebo condition (GW+IMWplacebo). Measurements will include respiratory muscle strength, DLCO (assessed at post-2, 30, 60, 90, and 120 minutes), respiratory function, and cardiorespiratory parameters during maximal exercise. This study is unique as it aims to detail the micro-level effects of IMW on pulmonary diffusion mechanisms and performance outcomes, providing novel insights into the ameliorative effects of IMW on respiratory function post-exercise. Additionally, it seeks to expand understanding of the mechanistic basis of IMW's benefits on both pulmonary diffusion capacity and athletic performance.
Detailed description
STUDY DESIGN This study will employ a placebo-controlled, randomized, crossover, and double-blind research design to evaluate the effects of three warm-up conditions: Control, Placebo 15%, and IMW 40%. Athletes will be randomly assigned to the conditions using a crossover approach, ensuring that all participants will experience each protocol on separate days.
The warm-up protocols will include:
General Warm-up (Control): A standard warm-up without resistance. IMW 40%: A general warm-up combined with inspiratory muscle warm-up at 40% resistance intensity.
Placebo 15%: A general warm-up combined with inspiratory muscle warm-up (placebo) at 15% resistance intensity.
Blinding will be maintained for both participants and researchers. Participants will be informed that the study aims to investigate various warm-up types, while the true purpose will remain concealed. This design will ensure reliability and minimize bias in the data to be collected.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: General warm-upParticipants only performed a general warm-up exercise. |
| IWM %15 Placebo | Placebo comparator | Other: Inspiratory muscle warm-up (Placebo - %15)In addition to the general warm-up, the participants performed IMW at 15% resistance intensity. |
| IWM %40 Intervention | Active comparator | Other: Inspiratory muscle warm-up (%40 IMW)In addition to the general warm-up, participants performed IMW at 40% resistance intensity. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 18-24 years.
- A training history of at least six years.
- Regular training frequency of at least four sessions per week.
Key exclusion criteria (4 listed)
- History of smoking.
- History of physical disability or acute respiratory or cardiovascular disease within the past three months.
- Diagnosis of SARS-CoV-2 within the past three months.
- Pulmonary function measurements outside the normal clinical range (≤ 80%).
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 |
|---|---|---|
| General warm-upThe General Warm-up (Control) protocol will consist of activities such as running and dynamic, active, and passive movements, adapted to suit the varied sports disciplines included in the study. These exercises will align with the principles of elevation, activation, and mobilization, aiming to enhance mobility across key muscle groups, from the arms and shoulders to the lower back and legs. Each session will include clear demonstrations to ensure proper technique and pacing, with participants performing a standardized number of repetitions. Researchers will supervise participants closely to verify accurate form and consistent execution during the intervention. | Other | Control |
| Inspiratory muscle warm-up (Placebo - %15)The placebo inspiratory muscle warm-up protocol will utilize the POWERbreathe® device at 15% of maximal inspiratory pressure (MIP). This placebo protocol will consist of two sets of 30 breaths, separated by a 60-second rest interval, with participants seated and wearing a nose clip. Proper technique will be taught during a prior familiarization session, and participants will be closely monitored during testing to ensure accurate execution. This protocol is designed to function as a placebo, effectively concealing the study's true objective to improve data validity and reliability. | Other | IWM %15 Placebo |
| Inspiratory muscle warm-up (%40 IMW)This study will implement a respiratory muscle warm-up protocol at 40% of maximal inspiratory pressure (MIP) using the POWERbreathe® device, as this intensity is considered optimal for effectively stimulating respiratory muscles. The protocol will consist of two sets of 30 breaths, with a 60-second rest period between sets, conducted while participants are seated and wearing a nose clip. Training for proper technique will be provided during the familiarization session, and participants will be closely monitored throughout the tests to ensure correct and consistent execution. | Other | IWM %40 Intervention |
Primary outcome
Lung Carbon Monoxide Diffusion Capacity (DLCO)
Time frame: Pre intervention and immediately post intervention
DLCO will be measured using the single breath-hold method with a Quark PFT gas analyzer, following ATS/ERS standards. Each test involves inhalation of a gas mixture (0.3% CO, 0.3% CH4, and dry air), breath-holding for 10±2 seconds, and exhalation. Subjects will undergo DLCO tests at baseline, following the warm-up protocols, and at both the start and conclusion of VO2max testing. Additional measurements will be conducted at 2, 30, 60, 90, and 120 minutes post-VO2max during each laboratory visit.
Pulmonary Function (FVC)
Time frame: Pre intervention and immediately post intervention
Forced Vital Capacity (FVC) will be assessed using the Quark PFT device according to ATS/ERS guidelines. Subjects will perform the FVC maneuver while seated, with disposable mouthpieces and a nose clip to ensure accurate recordings. The FVC maneuver will involve a maximal inhalation followed by a rapid and forceful exhalation into the spirometer until no more air can be expelled. Subjects will be encouraged to maintain consistent effort throughout the maneuver to ensure reliable and reproducible results.
Pulmonary Function (SVC)
Time frame: Pre intervention and immediately post intervention
Slow Vital Capacity (SVC) will be assessed using the Quark PFT device according to ATS/ERS guidelines. Subjects will perform the SVC maneuver while seated, with disposable mouthpieces and a nose clip to ensure accurate recordings. The SVC maneuver will start with a full, deep inhalation. This will be followed by a slow and controlled exhalation at a steady pace until the lungs are completely emptied. The maneuver will provide measurements reflecting lung volumes under non-forced conditions.
Pulmonary Functions (MVV)
Time frame: Pre intervention and immediately post intervention
Maximum Voluntary Ventilation (MVV) will be assessed using the Quark PFT device according to ATS/ERS guidelines. Subjects will perform the MVV maneuver while seated, with disposable mouthpieces and a nose clip to ensure accurate recordings. The MVV maneuver will evaluate the maximum amount of air a subject can inhale and exhale in a specific timeframe, typically 12 seconds. Subjects will be instructed to breathe as quickly and deeply as possible during the maneuver. Proper coaching will be provided to help maintain maximal effort while avoiding hyperventilation-related discomfort.
Respiratory Muscle Strength
Time frame: Pre intervention and immediately post intervention
Respiratory muscle strength will be measured using the Pony FX MIP/MEP device following ERS guidelines. For maximal respiratory pressures, subjects will exhale maximally, followed by a maximal inspiration against a closed valve (and the opposite maneuver). At least three trials with less than 5% variability will be averaged to determine the final values.
Bicycle ergometer and Maximal Aerobic Capacity (VO2max)
Time frame: Pre intervention and immediately post intervention
The test will begin at a workload of 50 (Watt) and will progress by increasing the workload by 25 (Watt) every two minutes. Throughout the test, the pedaling speed (rhythm) will be continuously monitored on the bicycle display, and participants will be instructed to maintain a steady pace within an average range of ≥60 (±5) rpm. Despite strong verbal encouragement provided during the test, it will be terminated if a participant spends more than 10 seconds below the 55 rpm pedal rhythm and decides they cannot continue further (voluntary exhaustion). After completing the test, participants will continue pedaling at a workload of 20 (Watt) for approximately 2 minutes for active recovery. Each test will be initiated in accordance with the workload optimization and adjustments to bike fit (saddle, handlebar height, and position) performed during the first visit. Cardiopulmonary data will be obtained using a breath-by-breath Quark CPET metabolic system (Mixing chamber system) (COSMED).
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 30 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing General warm-up and Inspiratory muscle warm-up (%40 IMW) in people with Athlete, run by Emre Karaduman.
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 4 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: opening soon, as of the sponsor's last update on 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Emre Karaduman, Ph.D (+90 5433021991, emre.karaduman@omu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung Carbon Monoxide Diffusion Capacity (DLCO) (time frame: Pre intervention and immediately post intervention). The study lists 6 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 30 Dec 2024.