HypoxiaNCT05967767
Repeated Sprint Training in Normobaric Hypoxia
A study testing Normobaric Hypoxia Exposure and Normobaric Normoxia Exposure in people with Hypoxia, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the current study was to examine the effects of 3-session repeated sprint training performed in a normobaric hypoxic condition with 48-hour rest intervals on sprint performance indices, arterial oxygen saturation (SpO2) and rating of perceived exertion (RPE) scores. Read more about this study
- Who is it for?
- Ages 18 to 22 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypoxia
- What is being tested?
- Normobaric Hypoxia Exposure and Normobaric Normoxia Exposure
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2022to 19 Dec 2022
- 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 18 to 22 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- non-smokers,
- male gender,
- those who do not have any chronic disease,
- do not use any medication,
- do not any training or accommodate above 1500 m altitude within the past 3 months,
- do not have any musculoskeletal injuries within the past 6 months and,
- train at least 3 days in a week.
Who cannot join
- Having a chronic or acute condition/disease during the intervention period
- Occurrence of acute respiratory illness or musculoskeletal injury during the intervention period
- Leaving the study voluntarily/on his own account
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Three Sessions of Repeated Sprint Training in Normobaric Hypoxia With 48-Hour Interval Improves Repeated Sprint Performance Indices
The aim of the current study was to examine the effects of 3-session repeated sprint training performed in a normobaric hypoxic condition with 48-hour rest intervals on sprint performance indices, arterial oxygen saturation (SpO2) and rating of perceived exertion (RPE) scores. Twenty-four moderately-trained males participated in this study voluntarily basis. This study was conducted on single-blind placebo-controlled design. Participants were divided into three groups as follows; normobaric hypoxia (3420 m; HYP), normobaric normoxia (162 m; PLA) and control group (CON). HYP and PLA groups subjected to 3 repeated sprint training session (4 set x 5 x 5 s sprints with 30 s recovery and 5 min rest between the sets) in normobaric hypoxia or normoxia condition. Pre- and pos-test were conducted 72 hours before and after the training intervention period. All the training and testing sessions performed in cycle ergometer. There were no detected significant time and condition interaction in the variables; relative peak power output (PPO), mean power output (MPO), percentage of sprint decrement score (Sdec%) and RPE observed in the scope of pre- and post-test.
Read the detailed description
This single-blind placebo-controlled designed study was approved by Ankara University Human Research Ethics Committee (2020/277) and conducted in accordance with the Declaration of Helsinki. The participants in normobaric hypoxia (HYP) and placebo (PLA) groups visited the laboratory six times and the control (CON) group visited three times. At the first visit of participants, the aim and the possible outcomes of the research was explained, the familiarization process for cycle ergometer and test/training protocol was performed, and the informed consent forms were obtained. The participants were divided randomly into three groups after the anthropometric measurements and baseline tests were completed so as part of the second visit. The groups were divided as follows; HYP group (n=9) which were exposed to normobaric hypoxia equal to 3420 m (FiO2: 13.5-13.6 %), PLA (n=7) that were exposed to normobaric normoxia equal to 162 m (FiO2: 20.9 %) through wearing the altitude generator mask, and the control group (CON; n=8) which was subjected to only pre and post-test. The determined hypoxic dose for HYP group was directly implemented (setting 9 was equal to 3420 m on used hypoxia generator), and no correction was made for the actual altitude (900 m, Golbasi, Ankara, Türkiye). The normobaric hypoxia and placebo condition was provided by Everest Summit II-Altitude Generator (Hypoxico Hypoxicator, New York, USA). At the 3rd-5th visits, HYP and PLA groups performed 3 repeated sprint training sessions under normobaric hypoxia or normoxia exposure with 48-hour intervals. And the participants visited the laboratory last time for post-test measurements. Each participant visited the laboratory for training sessions and test trials at the same time in the day. In the scope of pre and post-test repeated sprint indices, SpO2 and RPE data were collected. Pre-test and post-test were conducted 72 hours before and 72 hours after the training intervention period in normobaric normoxia condition. Including the testing days, the intervention period lasted 11 days in November 2022. All the experimental processes were conducted in Ankara University Performance Laboratory.
- Conditions
- Hypoxia
- Being tested
- Normobaric Hypoxia Exposure, Normobaric Normoxia Exposure
- Keywords
- normobaric hypoxia, repeated sprint training
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normobaric Hypoxia ExposureDevice
Hypoxia group were exposed to normobaric hypoxia equal to 3420 m (FiO2: 13.5-13.6 %).
Normobaric Normoxia ExposureDevice
Placebo group were exposed to normobaric normoxia equal to 162 m (FiO2: 20.9 %) through wearing the altitude generator mask.
| Study group | Role | What they receive |
|---|---|---|
| 3 Session Repeated Sprint Training in Normobaric Hypoxia | Experimental | Hypoxia group was exposed to normobaric hypoxia equal to 3420 m (FiO2: 13.5-13.6 %). Receives: Device: Normobaric Hypoxia Exposure |
| 3 Session Repeated Sprint Training in Normobaric Normoxia | Sham comparator | Placebo group was exposed to normobaric normoxia equal to 162 m (FiO2: 20.9 %) through wearing the altitude generator mask. Receives: Device: Normobaric Normoxia Exposure |
| Control group | No intervention | The control group was subjected to only pre and post-test. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative Peak Power Output
Relative peak power output (as newton meter) produced during the repeated cycling sprint tests by the participant in the scope of pre and post tests were recorded and assessed via Lode Cycling Ergometer Software. The total intervention period was 11 days from pre to post test. The change evaluated from pre to post test.
Measured: 11 days
Relative Mean Power Output
Relative mean power output (as newton meter) produced during the repeated cycling sprint tests by the participant in the scope of pre and post tests were recorded and assessed via Lode Cycling Ergometer Software. The total intervention period was 11 days from pre to post test. The change evaluated from pre to post test.
Measured: 11 days
Percentage of Sprint Decrement Score
Percentage of sprint decrement score calculated via relative peak power output produced during the repeated cycling sprint tests by the each participant in the scope of pre and post tests. The used sprint decrement score formula was as the follows; "Sdec% = [1 - (total power/ideal power)] × 100". Total power refers to accumulated PPO over the number of sprints and ideal power is defines the achieved highest PPO over the repetitions. An increase in the obtained score means that the sprint performance decreases.The total intervention period was 11 days from pre to post test. The change evaluated from pre to post test.
Measured: 11 days
Secondary outcomes (2)
Arterial Oxygen Saturation
Arterial oxygen saturation was measured and recorded via fingertip oximeter during the repeated cycling sprint tests for the end of the each sprint. The total intervention period was 11 days from pre to post test. The change evaluated from pre to post test.
Measured: 11 days
Rate of Perceived Exertion
Rate of Perceived exertion evaluated via 6-20 Borg scale and recorded during the repeated cycling sprint tests for the end of the each sprint. The total intervention period was 11 days from pre to post test. The change evaluated from pre to post test.
Scoring Level of Exertion 6 No Exertion 7 Extremely Light 8 9 Very Light 10 11 Light 12 13 Somewhat Hard 14 15 Hard (Heavy) 16 17 Very Hard 18 19 Extremely Hard 20 Maximal Exertion
Measured: 11 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 Nov 2022
- Primary completion25 Nov 2022
- Study completion19 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxiaStudies 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
- Parallel groups
- Model description
- single-blind placebo-controlled design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdulkadir Birol, Trabzon University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05967767
- Sponsor's protocol ID
- Interventional
- Status last verified
- Jul 2023
- First submitted
- 15 Jul 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Sessions of Repeated Sprint Training in Normobaric Hypoxia With 48-Hour Interval Improves Repeated Sprint Performance Indices
- ClinicalTrials.gov ID
- NCT05967767
- Acronym / sponsor ID
- Interventional
- Conditions
- Hypoxia
- Keywords
- normobaric hypoxia, repeated sprint training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 25 Nov 2022 (actual)
- Study completion
- 19 Dec 2022 (actual)
- First posted
- 1 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.
The aim of the current study was to examine the effects of 3-session repeated sprint training performed in a normobaric hypoxic condition with 48-hour rest intervals on sprint performance indices, arterial oxygen saturation (SpO2) and rating of perceived exertion (RPE) scores. Twenty-four moderately-trained males participated in this study voluntarily basis. This study was conducted on single-blind placebo-controlled design. Participants were divided into three groups as follows; normobaric hypoxia (3420 m; HYP), normobaric normoxia (162 m; PLA) and control group (CON). HYP and PLA groups subjected to 3 repeated sprint training session (4 set x 5 x 5 s sprints with 30 s recovery and 5 min rest between the sets) in normobaric hypoxia or normoxia condition. Pre- and pos-test were conducted 72 hours before and after the training intervention period. All the training and testing sessions performed in cycle ergometer. There were no detected significant time and condition interaction in the variables; relative peak power output (PPO), mean power output (MPO), percentage of sprint decrement score (Sdec%) and RPE observed in the scope of pre- and post-test.
Detailed description
This single-blind placebo-controlled designed study was approved by Ankara University Human Research Ethics Committee (2020/277) and conducted in accordance with the Declaration of Helsinki. The participants in normobaric hypoxia (HYP) and placebo (PLA) groups visited the laboratory six times and the control (CON) group visited three times. At the first visit of participants, the aim and the possible outcomes of the research was explained, the familiarization process for cycle ergometer and test/training protocol was performed, and the informed consent forms were obtained. The participants were divided randomly into three groups after the anthropometric measurements and baseline tests were completed so as part of the second visit. The groups were divided as follows; HYP group (n=9) which were exposed to normobaric hypoxia equal to 3420 m (FiO2: 13.5-13.6 %), PLA (n=7) that were exposed to normobaric normoxia equal to 162 m (FiO2: 20.9 %) through wearing the altitude generator mask, and the control group (CON; n=8) which was subjected to only pre and post-test. The determined hypoxic dose for HYP group was directly implemented (setting 9 was equal to 3420 m on used hypoxia generator), and no correction was made for the actual altitude (900 m, Golbasi, Ankara, Türkiye). The normobaric hypoxia and placebo condition was provided by Everest Summit II-Altitude Generator (Hypoxico Hypoxicator, New York, USA). At the 3rd-5th visits, HYP and PLA groups performed 3 repeated sprint training sessions under normobaric hypoxia or normoxia exposure with 48-hour intervals. And the participants visited the laboratory last time for post-test measurements. Each participant visited the laboratory for training sessions and test trials at the same time in the day. In the scope of pre and post-test repeated sprint indices, SpO2 and RPE data were collected. Pre-test and post-test were conducted 72 hours before and 72 hours after the training intervention period in normobaric normoxia condition. Including the testing days, the intervention period lasted 11 days in November 2022. All the experimental processes were conducted in Ankara University Performance Laboratory.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- single-blind placebo-controlled design
| Arm | Type | Receives |
|---|---|---|
| 3 Session Repeated Sprint Training in Normobaric Hypoxia | Experimental | Device: Normobaric Hypoxia ExposureHypoxia group was exposed to normobaric hypoxia equal to 3420 m (FiO2: 13.5-13.6 %). |
| 3 Session Repeated Sprint Training in Normobaric Normoxia | Sham comparator | Device: Normobaric Normoxia ExposurePlacebo group was exposed to normobaric normoxia equal to 162 m (FiO2: 20.9 %) through wearing the altitude generator mask. |
| Control group | No intervention | –The control group was subjected to only pre and post-test. |
Who may qualify
- Ages
- 18 to 22 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- non-smokers,
- male gender,
- those who do not have any chronic disease,
- do not use any medication,
- do not any training or accommodate above 1500 m altitude within the past 3 months,
Key exclusion criteria (3 listed)
- Having a chronic or acute condition/disease during the intervention period
- Occurrence of acute respiratory illness or musculoskeletal injury during the intervention period
- Leaving the study voluntarily/on his own account
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 |
|---|---|---|
| Normobaric Hypoxia ExposureHypoxia group were exposed to normobaric hypoxia equal to 3420 m (FiO2: 13.5-13.6 %). | Device | 3 Session Repeated Sprint Training in Normobaric Hypoxia |
| Normobaric Normoxia ExposurePlacebo group were exposed to normobaric normoxia equal to 162 m (FiO2: 20.9 %) through wearing the altitude generator mask. | Device | 3 Session Repeated Sprint Training in Normobaric Normoxia |
Primary outcome
Relative Peak Power Output
Time frame: 11 days
Relative peak power output (as newton meter) produced during the repeated cycling sprint tests by the participant in the scope of pre and post tests were recorded and assessed via Lode Cycling Ergometer Software. The total intervention period was 11 days from pre to post test. The change evaluated from pre to post test.
Relative Mean Power Output
Time frame: 11 days
Relative mean power output (as newton meter) produced during the repeated cycling sprint tests by the participant in the scope of pre and post tests were recorded and assessed via Lode Cycling Ergometer Software. The total intervention period was 11 days from pre to post test. The change evaluated from pre to post test.
Percentage of Sprint Decrement Score
Time frame: 11 days
Percentage of sprint decrement score calculated via relative peak power output produced during the repeated cycling sprint tests by the each participant in the scope of pre and post tests. The used sprint decrement score formula was as the follows; "Sdec% = [1 - (total power/ideal power)] × 100". Total power refers to accumulated PPO over the number of sprints and ideal power is defines the achieved highest PPO over the repetitions. An increase in the obtained score means that the sprint performance decreases.The total intervention period was 11 days from pre to post test. The change evaluated from pre to post test.
2 secondary outcomes
Arterial Oxygen Saturation
Time frame: 11 days
Rate of Perceived Exertion
Time frame: 11 days
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 1 Aug 2023.
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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?
A study testing Normobaric Hypoxia Exposure and Normobaric Normoxia Exposure in people with Hypoxia, run by Ankara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 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 1 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 Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
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?
Relative Peak Power Output (time frame: 11 days). The study lists 3 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 1 Aug 2023.