Repeated Sprint Training in Normobaric Hypoxia

July 22, 2023 updated by: Abdulkadir Birol, Ankara University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Ankara University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 3 Session Repeated Sprint Training in Normobaric Hypoxia
Hypoxia group was exposed to normobaric hypoxia equal to 3420 m (FiO2: 13.5-13.6 %).
Device: Normobaric Hypoxia Exposure
Hypoxia group were exposed to normobaric hypoxia equal to 3420 m (FiO2: 13.5-13.6 %).
Sham Comparator: 3 Session Repeated Sprint Training in Normobaric Normoxia
Placebo group was exposed to normobaric normoxia equal to 162 m (FiO2: 20.9 %) through wearing the altitude generator mask.
Device: Normobaric Normoxia Exposure
Placebo group were exposed to normobaric normoxia equal to 162 m (FiO2: 20.9 %) through wearing the altitude generator mask.
No Intervention: Control group
The control group was subjected to only pre and post-test.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
11 days
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.
11 days
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.
11 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Arterial Oxygen Saturation
Time Frame: 11 days
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.
11 days
Rate of Perceived Exertion
Time Frame: 11 days

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
11 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ankara University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 25, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 19, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 15, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 1, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Interventional (Oncolys BioPharma Inc)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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