NCT05967767

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2022

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2022

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 15, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

24 days

First QC Date

July 15, 2023

Last Update Submit

July 22, 2023

Conditions

Keywords

normobaric hypoxiarepeated sprint training

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    11 days

Secondary Outcomes (2)

  • Arterial Oxygen Saturation

    11 days

  • Rate of Perceived Exertion

    11 days

Study Arms (3)

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 %).

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.

Device: Normobaric Normoxia Exposure

Control group

NO INTERVENTION

The control group was subjected to only pre and post-test.

Interventions

Hypoxia group were exposed to normobaric hypoxia equal to 3420 m (FiO2: 13.5-13.6 %).

3 Session Repeated Sprint Training in Normobaric Hypoxia

Placebo group were exposed to normobaric normoxia equal to 162 m (FiO2: 20.9 %) through wearing the altitude generator mask.

3 Session Repeated Sprint Training in Normobaric Normoxia

Eligibility Criteria

Age18 Years - 22 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
In this study, blinding was provided in practice by using the simulation device for the normoxia condition.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: single-blind placebo-controlled design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 15, 2023

First Posted

August 1, 2023

Study Start

November 1, 2022

Primary Completion

November 25, 2022

Study Completion

December 19, 2022

Last Updated

August 1, 2023

Record last verified: 2023-07

Locations