Healty Male VolunteersNCT06736236
The Effect of Respiratory Muscle Warm-up on Pulmonary Diffusion Capacity in Athletes
A study testing Inspiratory muscle warm-up in people with Healty Male Volunteers and Athlete, run by Emre Karaduman.
Trial summary
Several studies suggest that inspiratory muscle warm-up (IMW) could potentially affect exercise performance; however, its mechanistic basis is still unclear. The aim of this study was to examine the effect of IMW on lung diffusing capacity for carbon monoxide, cardiorespiratory, perceptual and performance outcomes in… 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
- Healty Male Volunteers, Athlete
- What is being tested?
- Inspiratory muscle warm-up
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2024to 15 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: Effects of Inspiratory Muscle Warm-up on Diffusion Capacity for Carbon Monoxide, Cardiorespiratory, Perceptual and Performance Outcomes During High-intensity Exercise in Elite Athletes from Different Disciplines: a Randomized, Placebo-controlled, Double-blind and Crossover Study
Several studies suggest that inspiratory muscle warm-up (IMW) could potentially affect exercise performance; however, its mechanistic basis is still unclear. The aim of this study was to examine the effect of IMW on lung diffusing capacity for carbon monoxide, cardiorespiratory, perceptual and performance outcomes in elite athletes from different disciplines.
The aim of this study is to evaluate the effects of IMW on diffusion capacity for carbon monoxide, cardiorespiratory, perceptual and performance outcomes during high-intensity exercise in elite athletes from different disciplines. The study will be conducted using a randomized, placebo-controlled, double-blind and crossover study experimental design involving 35 athletes from various sports disciplines, including endurance, strength, skill-based, and mixed disciplines.
Participants will attend the laboratory on four separate occasions. During the first visit, they will be informed about the study and familiarized with the application and measurement procedures. In the second visit, a general warm-up will be performed. During the third and fourth visits, IMW (IMW40% or IMW placebo) protocols will be applied in addition to the general warm-up. Measurements of DLCO, pulmonary function tests, respiratory muscle strength, and gas analysis during maximal aerobic exercise will be collected both before and after the warm-up protocols.
Read the detailed description
- STUDY DESING 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 respiratory muscle exercise at 40% resistance.
Placebo 15%: A general warm-up combined with placebo respiratory muscle exercise at 15% resistance.
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
- Healty Male Volunteers, Athlete
- Being tested
- Inspiratory muscle warm-up, General warm-up (Control), Inspiratory muscle warm-up placebo (IMW %15)
- Keywords
- inspiratory muscle warm-up, warm-up, DLCO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle warm-upOther
Also called Respiratory muscle warm-up
This study will use a respiratory muscle warm-up protocol set at 40% of the maximal inspiratory pressure (MIP) using the POWERbreath® device, as this intensity has been shown to optimally stimulate respiratory muscles. The protocol involves two sets of 30 breaths with a 60-second rest between sets, performed with participants sitting and using a nose clip. Participants will be trained in this technique during the familiarization session and monitored throughout the tests to ensure proper execution.
General warm-up (Control)Other
The general warm-up (Control) protocol will include exercises such as running and dynamic, active, and passive movements tailored to the diverse sports disciplines in the study. These movements will follow the principles of elevation, activation, and mobilization, focusing on increasing mobility from the arms and shoulders to the lower back and legs. Each session will involve demonstrations emphasizing proper technique and speed, with participants completing a consistent number of repetitions. Researchers will monitor participants closely to ensure correct form and execution throughout the intervention.
Inspiratory muscle warm-up placebo (IMW %15)Other
The respiratory muscle warm-up protocol will be conducted at 15% of maximal inspiratory pressure (MIP) using the POWERbreath® device. This placebo protocol will involve two sets of 30 breaths, separated by a 60-second rest, with participants seated and wearing a nose clip. Training for the technique will occur during a familiarization session, and participants will be observed during tests to ensure proper execution. The purpose of this protocol is to serve as a placebo, masking the actual aim of the study to enhance data reliability.
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Participants only performed a general warm-up exercise. Receives: Other: General warm-up (Control) |
| IMW %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 (IMW %15) |
| IWM %40 (Experimental) | Experimental | In addition to the general warm-up, participants performed IMW at 40% resistance intensity. Receives: Other: Inspiratory muscle warm-up |
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 perform two DLCO tests at baseline, after warm-up protocols, and after VO2max testing during each laboratory visit.
Measured: Pre intervention and immediately post intervention
Pulmonary Functions
Pulmonary function will be assessed using the Quark PFT device according to ATS/ERS guidelines. Respiratory function will be assessed using forced, slow, and maximal voluntary maneuvers. Subjects will perform specific maneuvers for each parameter while seated, with disposable mouthpieces and a nose clip to ensure accurate recordings.
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 inspiratory pressure (MIP), subjects will exhale maximally, followed by a maximal inspiration against a closed valve. At least three trials with less than 5% variability will be averaged to determine the final values.
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 expiratory pressure (MEP), subjects will inhale maximally, followed by a maximal expiration against a closed valve. 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, Alban
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 posted16 Dec 2024
- Study start30 Dec 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion15 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healty Male VolunteersStudies 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
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emre Karaduman
- Sponsor type
- University, hospital or other
- Collaborators
- Ondokuz Mayıs University
- Responsible party
- Sponsor-investigator, Emre Karaduman, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06736236
- Sponsor's protocol ID
- PYO.YDS.1901.22.002
- Status last verified
- Dec 2024
- First submitted
- 9 Dec 2024
- Last updated
- 27 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 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Inspiratory Muscle Warm-up on Diffusion Capacity for Carbon Monoxide, Cardiorespiratory, Perceptual and Performance Outcomes During High-intensity Exercise in Elite Athletes from Different Disciplines: a Randomized, Placebo-controlled, Double-blind and Crossover Study
- ClinicalTrials.gov ID
- NCT06736236
- Acronym / sponsor ID
- PYO.YDS.1901.22.002
- Conditions
- Healty Male Volunteers, Athlete
- Keywords
- inspiratory muscle warm-up, warm-up, DLCO
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Emre KaradumanUniversity, hospital or other
- Collaborators
- Ondokuz Mayıs University
- Study start
- 30 Dec 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 15 Jan 2025 (estimated)
- First posted
- 16 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.
Several studies suggest that inspiratory muscle warm-up (IMW) could potentially affect exercise performance; however, its mechanistic basis is still unclear. The aim of this study was to examine the effect of IMW on lung diffusing capacity for carbon monoxide, cardiorespiratory, perceptual and performance outcomes in elite athletes from different disciplines.
The aim of this study is to evaluate the effects of IMW on diffusion capacity for carbon monoxide, cardiorespiratory, perceptual and performance outcomes during high-intensity exercise in elite athletes from different disciplines. The study will be conducted using a randomized, placebo-controlled, double-blind and crossover study experimental design involving 35 athletes from various sports disciplines, including endurance, strength, skill-based, and mixed disciplines.
Participants will attend the laboratory on four separate occasions. During the first visit, they will be informed about the study and familiarized with the application and measurement procedures. In the second visit, a general warm-up will be performed. During the third and fourth visits, IMW (IMW40% or IMW placebo) protocols will be applied in addition to the general warm-up. Measurements of DLCO, pulmonary function tests, respiratory muscle strength, and gas analysis during maximal aerobic exercise will be collected both before and after the warm-up protocols.
Detailed description
- STUDY DESING 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 respiratory muscle exercise at 40% resistance.
Placebo 15%: A general warm-up combined with placebo respiratory muscle exercise at 15% resistance.
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-up (Control)Participants only performed a general warm-up exercise. |
| IMW %15 (Placebo) | Placebo comparator | Other: Inspiratory muscle warm-up placebo (IMW %15)In addition to the general warm-up, the participants performed IMW at 15% resistance intensity. |
| IWM %40 (Experimental) | Experimental | Other: Inspiratory muscle warm-upIn 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 |
|---|---|---|
| Inspiratory muscle warm-upAlso: Respiratory muscle warm-upThis study will use a respiratory muscle warm-up protocol set at 40% of the maximal inspiratory pressure (MIP) using the POWERbreath® device, as this intensity has been shown to optimally stimulate respiratory muscles. The protocol involves two sets of 30 breaths with a 60-second rest between sets, performed with participants sitting and using a nose clip. Participants will be trained in this technique during the familiarization session and monitored throughout the tests to ensure proper execution. | Other | IWM %40 (Experimental) |
| General warm-up (Control)The general warm-up (Control) protocol will include exercises such as running and dynamic, active, and passive movements tailored to the diverse sports disciplines in the study. These movements will follow the principles of elevation, activation, and mobilization, focusing on increasing mobility from the arms and shoulders to the lower back and legs. Each session will involve demonstrations emphasizing proper technique and speed, with participants completing a consistent number of repetitions. Researchers will monitor participants closely to ensure correct form and execution throughout the intervention. | Other | Control |
| Inspiratory muscle warm-up placebo (IMW %15)The respiratory muscle warm-up protocol will be conducted at 15% of maximal inspiratory pressure (MIP) using the POWERbreath® device. This placebo protocol will involve two sets of 30 breaths, separated by a 60-second rest, with participants seated and wearing a nose clip. Training for the technique will occur during a familiarization session, and participants will be observed during tests to ensure proper execution. The purpose of this protocol is to serve as a placebo, masking the actual aim of the study to enhance data reliability. | Other | IMW %15 (Placebo) |
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 perform two DLCO tests at baseline, after warm-up protocols, and after VO2max testing during each laboratory visit.
Pulmonary Functions
Time frame: Pre intervention and immediately post intervention
Pulmonary function will be assessed using the Quark PFT device according to ATS/ERS guidelines. Respiratory function will be assessed using forced, slow, and maximal voluntary maneuvers. Subjects will perform specific maneuvers for each parameter while seated, with disposable mouthpieces and a nose clip to ensure accurate recordings.
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 inspiratory pressure (MIP), subjects will exhale maximally, followed by a maximal inspiration against a closed valve. At least three trials with less than 5% variability will be averaged to determine the final values.
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 expiratory pressure (MEP), subjects will inhale maximally, followed by a maximal expiration against a closed valve. 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, Alban
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 27 Dec 2024.
- Individual participant dataSharing planned: Undecided
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 Inspiratory muscle warm-up in people with Healty Male Volunteers and 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 27 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 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 27 Dec 2024.