Athletic PerformanceNCT06236490
Validation of Blood Oxygen Level Test in Well-trained Athletes
An observational study of Athletic Performance, run by Institute of Sport - National Research Institute, Poland at 1 site in Poland.
Trial summary
Blood Oxygen Level Test (BOLT) was never scientifically validated. Therefore, we investigated the association of BOLT scores with athletic performance in well-trained athletes. The study focuses on exercise tolerance in severe and extreme intensity domains, as they provoke significant homeostatic perturbations. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Athletic Performance
- What is being tested?
- Blood Oxygen Level Test, Wingate Anaerobic Test and Cardiopulmonary Exercise Test
- How many people
- 58 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jun 2023to 30 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Elite Speedskaters, Members of the National Team
Who may be able to join
- a valid medical certificate for competitive speedskating,
- a minimum of four years of competitive training,
- no prior exposure to respiratory or respiratory muscle training.
Who cannot join
- any chronic or acute medical condition within the last 4 weeks,
- recent stay at an altitude over 1500 meters above sea level within the last 4 weeks,
- the use of any ongoing medications, smoking, any ongoing allergy.
Trial locations and contacts
1 site in 1 country.
About this study
Blood Oxygen Level Test (BOLT) was never scientifically validated. Therefore, we investigated the association of BOLT scores with athletic performance in well-trained athletes. The study focuses on exercise tolerance in severe and extreme intensity domains, as they provoke significant homeostatic perturbations.
We perform Wingate Anaerobic Test and Cardiopulmonary Exercise Test, which are part of the regular National Team athletes screening in our lab, to see if the results may be assocciated with BOLT results.
The performance tests are used by the Speedskating National Team multiple times per year as training monitoring and performance assessments of the athletes.
Read the detailed description
The investigated group consisted of 49 well-trained speedskaters recruited with convenience sampling (out of 58 that volunteered to participate in the study). All the study participants were members of the Polish National Development Team or Polish National Elite Team in either long-track or short-track speedskating. Inclusion criteria were as follows: a valid medical certificate for competitive speedskating, a minimum of six years of training, and no prior exposure to respiratory or respiratory muscle training. Exclusion criteria were as follows: any chronic medical conditions, recent acute medical conditions within the last 4 weeks, COVID-19 infection within the last 6 months, recent stay in an altitude over 1500 meters above sea level within the last 4 weeks, and the use of any ongoing medications. The required sample size was calculated with G* Power (version 3.1.9.2; Germany), with effect size ƒ² = 0.35, level of significance set at α = 0.05, power (1 - β) = 0.95, and number of predictors = 1 (Linear multiple regression: Fixed model, R² deviation from zero). According to the calculations, the required total sample size was 40 participants. In our study, 58 participants were recruited to account for possible dropouts. Finally, 49 participants completed all the required procedures and were included in further analysis.
Three tests are used in the study:
Blood Oxygen Level Test (BOLT) was performed according to The Oxygen Advantage guidelines. The study participants rested for 15 minutes before measuring the BOLT score. During this time they were carefully instructed on how to perform the measurement. It was underlined that we do not measure how long one can hold their breath, but the time it takes for the body to react to lack of air and feel the desire to breathe. After a few normal breaths through the nose, after the exhalation, the participants held their breath until they felt the first definite desire to breathe or felt the first involuntary contractions of the respiratory muscles. The first was assessed by the participants, the latter was also visually assessed by the researchers. The nose was closed with the fingers to prevent any gas exchange. The researchers measured the time with a Finis 3x300M stopwatch (FINIS USA, Livermore, CA, USA). Time in seconds, to one decimal place, was noted as a BOLT score.
Wingate Anaerobic Test (WAnT) was conducted with Monark 874E Cycle Ergometer (Monark Exercise AB, Sweden). Before WAnT, the participants performed a 5-minute warm-up with resistance ranging from 0.8 to 1.2 W/kg. Next, the participants performed a maximal 6-second sprint, with the resistance adjusted to 7.5% of the individual body mass. After a rest interval of 2 to 5 minutes, the participants underwent a 30-second WAnT with resistance set at 7.5% of the individual body mass. They were instructed to attain the highest peak power output as quickly as possible and maintain the highest power output throughout the entire duration of the test. The participants received motivating and enthusiastic verbal support. The following indices were measured and included in the further analysis: peak power (Ppeak), total work (TW), WSSR. All the indices were calculated with the dedicated software (MCE 6.0, JBA Z. Staniak, Poland) linked to the cycle ergometer.
Cardiopulmonary Exercise Testing (CPET) was performed with the Cortex Metamax B3 (Cortex Biophysik GmbH, Leipzig, Germany), breath-by-breath method, and Cyclus II Ergometer (RBM, Leipzig, Germany). Participants underwent an incremental ramp test, commencing at 55-70W and incrementally increasing the load by 0.17-0.28 W·sec-1, individually adjusted for body mass. The participants were instructed to continue the effort until total exhaustion. All the participants fulfilled at least five out of the six maximum effort criteria as follows: 1) respiratory exchange ratio ≥ 1.10, (2) present VO2 plateau (growth < 100 mL·min-1 in VO2 despite increased cycling power), (3) respiratory frequency ≥ 45 breaths·min-1, (4) declared subjective exertion intensity during CPET ≥ 18 according to the Borg Scale, (5) blood lactate concentration ≥8 mmol·L-1, (6) peak heart rate ≥ 15 beats·min-1 below predicted maximal heart rate (HRmax) . The following indices were measured with 15 second intervals and included in the further analysis: maximum oxygen uptake (VO2max) in mL·min-¹·kg-¹, and time from achieving VO2max to the cessation of the test (TtC) in seconds.
All the athletes were familiarised with testing procedures, as they peformed them multiple times before. The medical screening is performed on a testing day in the morning. All the athletes have to undergone the medical screening.
Further, the performance test results will be used to validate BOLT test in terms of association with athletic performance.
- Conditions
- Athletic Performance
- Being tested
- Blood Oxygen Level Test, Wingate Anaerobic Test, Cardiopulmonary Exercise Test
- Keywords
- bolt, blood oxygen level test, chemosensitivity, baroreceptor sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Oxygen Level TestDiagnostic test
The study participants rested for 15 minutes before measuring the BOLT score. During this time they were carefully instructed on how to perform the measurement. It was underlined that we do not measure how long one can hold their breath, but the time it takes for the body to react to lack of air and feel the desire to breathe. After a few normal breaths through the nose, after the exhalation, the participants held their breath until they felt the first definite desire to breathe or felt the first involuntary contractions of the respiratory muscles. The first was assessed by the participants, the latter was also visually assessed by the researchers. The nose was closed with the fingers to prevent any gas exchange. The researchers measured the time with a Finis 3x300M stopwatch (FINIS USA, Livermore, CA, USA). Time in seconds, to one decimal place, was noted as a BOLT score. The visualisation of BOLT is presented in Figure 2.
Wingate Anaerobic TestDiagnostic test
WAnT was conducted with Monark 874E Cycle Ergometer (Monark Exercise AB, Sweden). Before WAnT, the participants performed a 5-minute warm-up with resistance ranging from 0.8 to 1.2 W/kg. Next, the participants performed a maximal 6-second sprint, with the resistance adjusted to 7.5% of the individual body mass. After a rest interval of 2 to 5 minutes, the participants underwent a 30-second WAnT with resistance set at 7.5% of the individual body mass. They were instructed to attain the highest peak power output as quickly as possible and maintain the highest power output throughout the entire duration of the test. The participants received motivating and enthusiastic verbal support. The following indices were measured and included in the further analysis: peak power (Ppeak), total work (TW), WSSR. All the indices were calculated with the dedicated software (MCE 6.0, JBA Z. Staniak, Poland) linked to the cycle ergometer.
Cardiopulmonary Exercise TestDiagnostic test
CPET was performed with the Cortex Metamax B3 (Cortex Biophysik GmbH, Leipzig, Germany), breath-by-breath method, and Cyclus II Ergometer (RBM, Leipzig, Germany). Participants underwent an incremental ramp test, commencing at 55-70W and incrementally increasing the load by 0.17-0.28 W·sec-1, individually adjusted for body mass. The participants were instructed to continue the effort until total exhaustion. All the participants fulfilled the maximum effort criteria (Wiecha et al. 2023): 1) respiratory exchange ratio ≥ 1.10, (2) present VO2 plateau (growth < 100 mL·min-1 in VO2 despite increased cycling power), (3) respiratory frequency ≥ 45 breaths·min-1, (4) declared subjective exertion intensity during CPET ≥ 18 according to the Borg Scale (Borg 1998), (5) blood lactate concentration ≥8 mmol·L-1, (6) peak heart rate ≥ 15 beats·min-1 below predicted maximal heart rate (HRmax) (Lach et al. 2021).
| Study group | Role | What they receive |
|---|---|---|
| Study Particpants - Speedskating Athletes | All the study participants were members of the Polish National Development Team or Polish National Elite Team in either long-track or short-track speedskating. Inclusion criteria were as follows: a valid medical certificate for competitive speedskating, a minimum of six years of training, and no prior exposure to respiratory or respiratory muscle training. Exclusion criteria were as follows: any chronic medical conditions, recent acute medical conditions within the last 4 weeks, COVID-19 infection within the last 6 months, recent stay in an altitude over 1500 meters above sea level within the last 4 weeks, and the use of any ongoing medications. Receives: Diagnostic Test: Blood Oxygen Level Test; Diagnostic Test: Wingate Anaerobic Test; Diagnostic Test: Cardiopulmonary Exercise Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Oygen Level Score
Voluntary breatholding untill the first signs of discomfort of respiratory muscle contraction, measured in seconds.
Measured: June-September 2023
Wingate Test Result - total completed work
Total work completed during Wingate 30 second test, measured in kilojouls
Measured: June-September 2023
Maximal Oxygen Uptake - VO2max
Maximal oxygen uptake, measured in ml/kg/min.
Measured: June-September 2023
Time to cessation during cardiopulmonary testing
Time in seconds from achieving oxygen uptate plateau to cessation of exercise.
Measured: June-September 2023
Wingate Test Result - peak power
Peak power during Wingate 30 second test, measured in watts.
Measured: June-September 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start1 Jun 2023
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Athletic PerformanceStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Sport - National Research Institute, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomasz Kowalski, Institute of Sport - National Research Institute, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06236490
- Sponsor's protocol ID
- InstSportPoland
- Status last verified
- Jan 2024
- First submitted
- 24 Jan 2024
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Blood Oxygen Level Test in Well-trained Athletes
- ClinicalTrials.gov ID
- NCT06236490
- Acronym / sponsor ID
- InstSportPoland
- Conditions
- Athletic Performance
- Keywords
- bolt, blood oxygen level test, chemosensitivity, baroreceptor sensitivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Institute of Sport - National Research Institute, PolandUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 1 Feb 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.
Blood Oxygen Level Test (BOLT) was never scientifically validated. Therefore, we investigated the association of BOLT scores with athletic performance in well-trained athletes. The study focuses on exercise tolerance in severe and extreme intensity domains, as they provoke significant homeostatic perturbations.
We perform Wingate Anaerobic Test and Cardiopulmonary Exercise Test, which are part of the regular National Team athletes screening in our lab, to see if the results may be assocciated with BOLT results.
The performance tests are used by the Speedskating National Team multiple times per year as training monitoring and performance assessments of the athletes.
Detailed description
The investigated group consisted of 49 well-trained speedskaters recruited with convenience sampling (out of 58 that volunteered to participate in the study). All the study participants were members of the Polish National Development Team or Polish National Elite Team in either long-track or short-track speedskating. Inclusion criteria were as follows: a valid medical certificate for competitive speedskating, a minimum of six years of training, and no prior exposure to respiratory or respiratory muscle training. Exclusion criteria were as follows: any chronic medical conditions, recent acute medical conditions within the last 4 weeks, COVID-19 infection within the last 6 months, recent stay in an altitude over 1500 meters above sea level within the last 4 weeks, and the use of any ongoing medications. The required sample size was calculated with G* Power (version 3.1.9.2; Germany), with effect size ƒ² = 0.35, level of significance set at α = 0.05, power (1 - β) = 0.95, and number of predictors = 1 (Linear multiple regression: Fixed model, R² deviation from zero). According to the calculations, the required total sample size was 40 participants. In our study, 58 participants were recruited to account for possible dropouts. Finally, 49 participants completed all the required procedures and were included in further analysis.
Three tests are used in the study:
Blood Oxygen Level Test (BOLT) was performed according to The Oxygen Advantage guidelines. The study participants rested for 15 minutes before measuring the BOLT score. During this time they were carefully instructed on how to perform the measurement. It was underlined that we do not measure how long one can hold their breath, but the time it takes for the body to react to lack of air and feel the desire to breathe. After a few normal breaths through the nose, after the exhalation, the participants held their breath until they felt the first definite desire to breathe or felt the first involuntary contractions of the respiratory muscles. The first was assessed by the participants, the latter was also visually assessed by the researchers. The nose was closed with the fingers to prevent any gas exchange. The researchers measured the time with a Finis 3x300M stopwatch (FINIS USA, Livermore, CA, USA). Time in seconds, to one decimal place, was noted as a BOLT score.
Wingate Anaerobic Test (WAnT) was conducted with Monark 874E Cycle Ergometer (Monark Exercise AB, Sweden). Before WAnT, the participants performed a 5-minute warm-up with resistance ranging from 0.8 to 1.2 W/kg. Next, the participants performed a maximal 6-second sprint, with the resistance adjusted to 7.5% of the individual body mass. After a rest interval of 2 to 5 minutes, the participants underwent a 30-second WAnT with resistance set at 7.5% of the individual body mass. They were instructed to attain the highest peak power output as quickly as possible and maintain the highest power output throughout the entire duration of the test. The participants received motivating and enthusiastic verbal support. The following indices were measured and included in the further analysis: peak power (Ppeak), total work (TW), WSSR. All the indices were calculated with the dedicated software (MCE 6.0, JBA Z. Staniak, Poland) linked to the cycle ergometer.
Cardiopulmonary Exercise Testing (CPET) was performed with the Cortex Metamax B3 (Cortex Biophysik GmbH, Leipzig, Germany), breath-by-breath method, and Cyclus II Ergometer (RBM, Leipzig, Germany). Participants underwent an incremental ramp test, commencing at 55-70W and incrementally increasing the load by 0.17-0.28 W·sec-1, individually adjusted for body mass. The participants were instructed to continue the effort until total exhaustion. All the participants fulfilled at least five out of the six maximum effort criteria as follows: 1) respiratory exchange ratio ≥ 1.10, (2) present VO2 plateau (growth < 100 mL·min-1 in VO2 despite increased cycling power), (3) respiratory frequency ≥ 45 breaths·min-1, (4) declared subjective exertion intensity during CPET ≥ 18 according to the Borg Scale, (5) blood lactate concentration ≥8 mmol·L-1, (6) peak heart rate ≥ 15 beats·min-1 below predicted maximal heart rate (HRmax) . The following indices were measured with 15 second intervals and included in the further analysis: maximum oxygen uptake (VO2max) in mL·min-¹·kg-¹, and time from achieving VO2max to the cessation of the test (TtC) in seconds.
All the athletes were familiarised with testing procedures, as they peformed them multiple times before. The medical screening is performed on a testing day in the morning. All the athletes have to undergone the medical screening.
Further, the performance test results will be used to validate BOLT test in terms of association with athletic performance.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Particpants - Speedskating Athletes | – | Diagnostic Test: Blood Oxygen Level Test, Diagnostic Test: Wingate Anaerobic Test, Diagnostic Test: Cardiopulmonary Exercise TestAll the study participants were members of the Polish National Development Team or Polish National Elite Team in either long-track or short-track speedskating. Inclusion criteria were as follows: a valid medical certificate for competitive speedskating, a minimum of six years of training, and no prior exposure to respiratory or respiratory muscle training. Exclusion criteria were as follows: any chronic medical conditions, recent acute medical conditions within the last 4 weeks, COVID-19 infection within the last 6 months, recent stay in an altitude over 1500 meters above sea level within the last 4 weeks, and the use of any ongoing medications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Elite Speedskaters, Members of the National Team
Key inclusion criteria (3 listed)
- a valid medical certificate for competitive speedskating,
- a minimum of four years of competitive training,
- no prior exposure to respiratory or respiratory muscle training.
Key exclusion criteria (3 listed)
- any chronic or acute medical condition within the last 4 weeks,
- recent stay at an altitude over 1500 meters above sea level within the last 4 weeks,
- the use of any ongoing medications, smoking, any ongoing allergy.
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 |
|---|---|---|
| Blood Oxygen Level TestThe study participants rested for 15 minutes before measuring the BOLT score. During this time they were carefully instructed on how to perform the measurement. It was underlined that we do not measure how long one can hold their breath, but the time it takes for the body to react to lack of air and feel the desire to breathe. After a few normal breaths through the nose, after the exhalation, the participants held their breath until they felt the first definite desire to breathe or felt the first involuntary contractions of the respiratory muscles. The first was assessed by the participants, the latter was also visually assessed by the researchers. The nose was closed with the fingers to prevent any gas exchange. The researchers measured the time with a Finis 3x300M stopwatch (FINIS USA, Livermore, CA, USA). Time in seconds, to one decimal place, was noted as a BOLT score. The visualisation of BOLT is presented in Figure 2. | Diagnostic test | Study Particpants - Speedskating Athletes |
| Wingate Anaerobic TestWAnT was conducted with Monark 874E Cycle Ergometer (Monark Exercise AB, Sweden). Before WAnT, the participants performed a 5-minute warm-up with resistance ranging from 0.8 to 1.2 W/kg. Next, the participants performed a maximal 6-second sprint, with the resistance adjusted to 7.5% of the individual body mass. After a rest interval of 2 to 5 minutes, the participants underwent a 30-second WAnT with resistance set at 7.5% of the individual body mass. They were instructed to attain the highest peak power output as quickly as possible and maintain the highest power output throughout the entire duration of the test. The participants received motivating and enthusiastic verbal support. The following indices were measured and included in the further analysis: peak power (Ppeak), total work (TW), WSSR. All the indices were calculated with the dedicated software (MCE 6.0, JBA Z. Staniak, Poland) linked to the cycle ergometer. | Diagnostic test | Study Particpants - Speedskating Athletes |
| Cardiopulmonary Exercise TestCPET was performed with the Cortex Metamax B3 (Cortex Biophysik GmbH, Leipzig, Germany), breath-by-breath method, and Cyclus II Ergometer (RBM, Leipzig, Germany). Participants underwent an incremental ramp test, commencing at 55-70W and incrementally increasing the load by 0.17-0.28 W·sec-1, individually adjusted for body mass. The participants were instructed to continue the effort until total exhaustion. All the participants fulfilled the maximum effort criteria (Wiecha et al. 2023): 1) respiratory exchange ratio ≥ 1.10, (2) present VO2 plateau (growth < 100 mL·min-1 in VO2 despite increased cycling power), (3) respiratory frequency ≥ 45 breaths·min-1, (4) declared subjective exertion intensity during CPET ≥ 18 according to the Borg Scale (Borg 1998), (5) blood lactate concentration ≥8 mmol·L-1, (6) peak heart rate ≥ 15 beats·min-1 below predicted maximal heart rate (HRmax) (Lach et al. 2021). | Diagnostic test | Study Particpants - Speedskating Athletes |
Primary outcome
Blood Oygen Level Score
Time frame: June-September 2023
Voluntary breatholding untill the first signs of discomfort of respiratory muscle contraction, measured in seconds.
Wingate Test Result - total completed work
Time frame: June-September 2023
Total work completed during Wingate 30 second test, measured in kilojouls
Maximal Oxygen Uptake - VO2max
Time frame: June-September 2023
Maximal oxygen uptake, measured in ml/kg/min.
Time to cessation during cardiopulmonary testing
Time frame: June-September 2023
Time in seconds from achieving oxygen uptate plateau to cessation of exercise.
Wingate Test Result - peak power
Time frame: June-September 2023
Peak power during Wingate 30 second test, measured in watts.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Athletic Performance, run by Institute of Sport - National Research Institute, Poland at 1 site in Poland.
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 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2024. 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 Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Oygen Level Score (time frame: June-September 2023). 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 2 Feb 2024.