Blood Lactate DecreaseNCT05994092
Influence of Voluntary Isocapnic Hyperpnea on Blood Lactate Level and Rate of Perceived Exertion
A study testing Voluntary Isocapnic Hyperpnea in people with Blood Lactate Decrease, run by Institute of Sport - National Research Institute, Poland at 1 site in Poland.
Trial summary
All the study participants performed the Wingate Anaerobic Test (WAnT) with maximal effort. The experimental group (E) performed a 3-minute recovery protocol based on low-intensity breathing Voluntary Isocapnic Hyperpnea exercises 20 minuter after cessation of the exercise, whereas the control group (C) used passive… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Blood Lactate Decrease
- What is being tested?
- Voluntary Isocapnic Hyperpnea
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 sitePoland
- Study dates
- 10 Jun 2023to 30 Jul 2023
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
The inclusion criteria:
- valid medical certificate to compete in speedskating,
- lack of previous experience with RMT,
- at least 6 years of athletic training.
The exclusion criteria:
- any chronic medical condition,
- any acute medical condition within last 3 months,
- any ongoing medication intake.
Trial locations and contacts
1 site in 1 country.
About this study
All the study participants performed the Wingate Anaerobic Test (WAnT) with maximal effort. The experimental group (E) performed a 3-minute recovery protocol based on low-intensity breathing Voluntary Isocapnic Hyperpnea exercises 20 minuter after cessation of the exercise, whereas the control group (C) used passive recovery only. All study participants were advised to sit during the 30-minute period, with minimal walking in order to meet the physiological needs allowed. The blood samples were taken 3 minutes and 30 minutes after cessation of the exercise to measure the bLa. The Borg CR-10 Scale was presented to the participants 3 minutes and 30 minutes after cessation of the exercise to measure the rate of perceived exertion (RPE) (Borg, 1998).
Read the detailed description
All the study participants performed the Wingate Anaerobic Test (WAnT) with maximal effort. The experimental group (E) performed a 3-minute recovery protocol based on low-intensity breathing VIH exercises 20 minuter after cessation of the exercise, whereas the control group (C) used passive recovery only. All study participants were advised to sit during the 30-minute period, with minimal walking in order to meet the physiological needs allowed. The blood samples were taken 3 minutes and 30 minutes after cessation of the exercise to measure the bLa. The Borg CR-10 Scale was presented to the participants 3 minutes and 30 minutes after cessation of the exercise to measure the rate of perceived exertion (RPE).
WAnT was conducted using a Monark 874E Cycle Ergometer (Monark Exercise AB, Sweden). Prior to the test, a standard warm-up of 5 minutes was performed with a load of 0.8-1.2 W/kg. Then, athletes performed a maximal 6-second sprint with a load adjusted to 7.5% of the individual body weight. Following a 2-minute rest period, the athletes underwent a 30-second WAnT with the load adjusted to 7.5% of the individual body weight. The objective for the subjects was to achieve the highest possible peak power as fast as possible and maintain the highest power output throughout the whole test duration. Loud and dynamic verbal encouragement was provided. The testing took place between 9:00 and 10:30 AM. The basic mechanical parameters of the exercise, including performed work and maximum power, were computed with dedicated software (MCE 6.0 - JBA Z. Staniak, Poland) linked to the cycle ergometer.
The recovery protocol consisted of 3' of breathing with 20 breaths·min-1 frequency. The Isocapnic BreathWayBetter devices (Isocapnic Technologies Inc, Kelowna, Canada) with 6-liter bags were used. The protocol was performed in a seating position.
Blood samples were taken from fingertips by skilled technicians to 20 uL capillary tubes. bLa was measured with Super GL2 analyzer (Dr. Müller Gerätebau GmbH, Freital, Germany).
Whereas participants and data collectors were aware of the allocated training method, the laboratory technicians performing biochemistry assays were kept blinded to the allocation. The participants were assigned at random to either E or C group to perform VIH protocol under a supervision of qualified physiotherapist.
Stratified randomization to assign the participants was used. First, the participants were assigned to subgroups based on the membership in National Development or National Elite Team. Then, the participants were assigned to subgroups based on the gender. Then, the participants were assigned to E or C group based on the coin toss.
- Conditions
- Blood Lactate Decrease
- Being tested
- Voluntary Isocapnic Hyperpnea
- Keywords
- Voluntary Isocapnic Hyperpnea, Lactate Clearance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voluntary Isocapnic HyperpneaBehavioural
The protocol of 3' of breathing with 20 breaths·min-1 frequency. The Isocapnic BreathWayBetter devices (Isocapnic Technologies Inc, Kelowna, Canada) with 6-liter bags were used. The protocol was performed in a seating position.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Not described Receives: Behavioral: Voluntary Isocapnic Hyperpnea |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in blood lactate (bLa)
The blood samples were taken 3 minutes and 30 minutes after cessation of the exercise to measure the bLa.
Blood samples were taken from fingertips by skilled technicians to 20 uL capillary tubes. bLa was measured with Super GL2 analyzer (Dr. Müller Gerätebau GmbH, Freital, Germany).
Measured: 30 minutes
Changes in rate of perceived exertion (RPE)
The Borg CR-10 Scale was presented to the participants 3 minutes and 30 minutes after cessation of the exercise to measure the rate of perceived exertion (RPE) (Borg, 1998).
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start10 Jun 2023
- Primary completion30 Jul 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood Lactate DecreaseStudies 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
- Parallel groups
- Model description
- Parallel Group Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 39 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
- NCT05994092
- Sponsor's protocol ID
- TK03/2023
- Status last verified
- Aug 2023
- First submitted
- 8 Aug 2023
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon reasonable request.
Publications
Kowalski T, Wilk A, Rebis K, Lohse KM, Sadowska D, Klusiewicz A. Influence of voluntary isocapnic hyperpnoea on recovery after high-intensity exercise in elite short-track speedskaters - randomized controlled trial. BMC Sports Sci Med Rehabil. 2024 Jun 20;16(1):137. doi: 10.1186/s13102-024-00927-0.
PubMed 38902811
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Voluntary Isocapnic Hyperpnea on Blood Lactate Level and Rate of Perceived Exertion
- ClinicalTrials.gov ID
- NCT05994092
- Acronym / sponsor ID
- TK03/2023
- Conditions
- Blood Lactate Decrease
- Keywords
- Voluntary Isocapnic Hyperpnea, Lactate Clearance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Institute of Sport - National Research Institute, PolandUniversity, hospital or other
- Study start
- 10 Jun 2023 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 16 Aug 2023 (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.
All the study participants performed the Wingate Anaerobic Test (WAnT) with maximal effort. The experimental group (E) performed a 3-minute recovery protocol based on low-intensity breathing Voluntary Isocapnic Hyperpnea exercises 20 minuter after cessation of the exercise, whereas the control group (C) used passive recovery only. All study participants were advised to sit during the 30-minute period, with minimal walking in order to meet the physiological needs allowed. The blood samples were taken 3 minutes and 30 minutes after cessation of the exercise to measure the bLa. The Borg CR-10 Scale was presented to the participants 3 minutes and 30 minutes after cessation of the exercise to measure the rate of perceived exertion (RPE) (Borg, 1998).
Detailed description
All the study participants performed the Wingate Anaerobic Test (WAnT) with maximal effort. The experimental group (E) performed a 3-minute recovery protocol based on low-intensity breathing VIH exercises 20 minuter after cessation of the exercise, whereas the control group (C) used passive recovery only. All study participants were advised to sit during the 30-minute period, with minimal walking in order to meet the physiological needs allowed. The blood samples were taken 3 minutes and 30 minutes after cessation of the exercise to measure the bLa. The Borg CR-10 Scale was presented to the participants 3 minutes and 30 minutes after cessation of the exercise to measure the rate of perceived exertion (RPE).
WAnT was conducted using a Monark 874E Cycle Ergometer (Monark Exercise AB, Sweden). Prior to the test, a standard warm-up of 5 minutes was performed with a load of 0.8-1.2 W/kg. Then, athletes performed a maximal 6-second sprint with a load adjusted to 7.5% of the individual body weight. Following a 2-minute rest period, the athletes underwent a 30-second WAnT with the load adjusted to 7.5% of the individual body weight. The objective for the subjects was to achieve the highest possible peak power as fast as possible and maintain the highest power output throughout the whole test duration. Loud and dynamic verbal encouragement was provided. The testing took place between 9:00 and 10:30 AM. The basic mechanical parameters of the exercise, including performed work and maximum power, were computed with dedicated software (MCE 6.0 - JBA Z. Staniak, Poland) linked to the cycle ergometer.
The recovery protocol consisted of 3' of breathing with 20 breaths·min-1 frequency. The Isocapnic BreathWayBetter devices (Isocapnic Technologies Inc, Kelowna, Canada) with 6-liter bags were used. The protocol was performed in a seating position.
Blood samples were taken from fingertips by skilled technicians to 20 uL capillary tubes. bLa was measured with Super GL2 analyzer (Dr. Müller Gerätebau GmbH, Freital, Germany).
Whereas participants and data collectors were aware of the allocated training method, the laboratory technicians performing biochemistry assays were kept blinded to the allocation. The participants were assigned at random to either E or C group to perform VIH protocol under a supervision of qualified physiotherapist.
Stratified randomization to assign the participants was used. First, the participants were assigned to subgroups based on the membership in National Development or National Elite Team. Then, the participants were assigned to subgroups based on the gender. Then, the participants were assigned to E or C group based on the coin toss.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Group Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Voluntary Isocapnic Hyperpnea |
| Control | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Voluntary Isocapnic HyperpneaThe protocol of 3' of breathing with 20 breaths·min-1 frequency. The Isocapnic BreathWayBetter devices (Isocapnic Technologies Inc, Kelowna, Canada) with 6-liter bags were used. The protocol was performed in a seating position. | Behavioural | Experimental |
Primary outcome
Changes in blood lactate (bLa)
Time frame: 30 minutes
The blood samples were taken 3 minutes and 30 minutes after cessation of the exercise to measure the bLa. Blood samples were taken from fingertips by skilled technicians to 20 uL capillary tubes. bLa was measured with Super GL2 analyzer (Dr. Müller Gerätebau GmbH, Freital, Germany).
Changes in rate of perceived exertion (RPE)
Time frame: 30 minutes
The Borg CR-10 Scale was presented to the participants 3 minutes and 30 minutes after cessation of the exercise to measure the rate of perceived exertion (RPE) (Borg, 1998).
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 18 Aug 2023.
- Derived from this study: PubMed 38902811Kowalski T, Wilk A, Rebis K, Lohse KM, Sadowska D, Klusiewicz A. Influence of voluntary isocapnic hyperpnoea on recovery after high-intensity exercise in elite short-track speedskaters - randomized controlled trial. BMC Sports Sci Med Rehabil. 2024 Jun 20;16(1):137. doi: 10.1186/s13102-024-00927-0.
- Individual participant dataSharing planned: Yes. Upon reasonable request.
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?
A study testing Voluntary Isocapnic Hyperpnea in people with Blood Lactate Decrease, 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.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2023. 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?
Changes in blood lactate (bLa) (time frame: 30 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05994092, which also lists 1 linked publication.
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 18 Aug 2023.