NCT05439239

Brief Summary

With the increased participation of women in sports, it is essential to develop gender-tailored training strategies for improving exercise performance. Males and females exhibit gender-specific characteristics and they therefore respond differently to physical exercise. Improving repeated sprint ability (RSA, i.e., ability to perform repeated short duration sprints separated by brief recovery intervals) in women is important for sports performance, as it is a key factor in most team and racket sports. Repeated sprint training in hypoxia is increasingly popular in this field, as it has demonstrated further improvements in sea-level repeated sprint performance than similar training in normoxia. However, these observations are based mainly on male athletes. Whether the effects of hypoxic repeated sprint training on repeated sprint performance in normoxia differ between genders is not yet known, therefore the investigators propose to examine those possible differences in this study. The aim of this study is to investigate whether the effects of hypoxic repeated sprint training on repeated sprint performance in normoxia differ between males and females who participate in team/racket sports. Considering the sex-specific characteristics that males and females exhibit, the investigators hypothesize that after 7 weeks of hypoxic repeated sprint training the improvements in repeated sprint ability at sea level will be greater in males than in females. To answer this question, the investigators will measure the following: body composition (lean body mass); body weight and height; VO2max; blood (estrogen, lactate, hemoglobin, hematocrit); repeated sprint ability (RSA) test; muscle oxygenation (concentrations for oxyhemoglobin, deoxyhemoglobin, and total hemoglobin/myoglobin); 30-s Wingate test; heart rate (HR); power output; rate of perceived exertion (RPE); visual analogue scale (VAS; pain level in legs). The investigators will recruit 48 volunteers and they will randomly assign them into the normoxic or hypoxic training group, without giving any information about their group. The volunteers should meet the following inclusion criteria: females (on monophasic oral contraceptive pill) and males, age between 18-40 years, recreationally participating in team/racket sports min 3h/week with at least 2 years of experience prior to the study. Exclusion criteria will be: smoking, exposure to altitude \>1500 m one month before the study, any health conditions or injuries that could compromise the participant's safety during training/testing, prescribed medication, performing repeated sprint training more than once per week. Males and females, matched for VO2max and sprint performance, will perform repeated sprint training (3 sets during week 1-6, 2 sets during week 7 with 5min active recovery in between, 5 x 10s maximal sprints with 20s active recovery in between) in hypoxia or normoxia 2x/week for 7 weeks. Before and after the training period, the following tests and measurements will be performed: body composition analysis, VO2max test, blood sampling for measuring hemoglobin and estrogen concentrations and hematocrit, determination of hemoglobin mass, RSA test, muscle oxygenation assessment during RSA test, 30-s Wingate test and blood lactate measurements.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 21, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 31, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 30, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

June 30, 2022

Status Verified

June 1, 2022

Enrollment Period

8 months

First QC Date

May 31, 2022

Last Update Submit

June 27, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Repeated sprint cycling performance in normoxia in males and females who participate in team or racket sports.

    Performance will be determined through a repeated sprint ability test on the cycle ergometer, by the number of sprints and the power output during the sprints. The repeated sprint cycling performance will be assessed before and after a 7-week training program of repeated sprints in normoxia or hypoxia.

    The primary outcome will be assessed twice for each participant: one time before the training program and one time after the training program. Testing will last no more than one hour.

Secondary Outcomes (7)

  • Endurance capacity assessed using a maximal effort test on the cycle ergometer, namely VO2max test.

    The secondary outcomes will be assessed twice for each participant: one time before the training program and one time after the training program.

  • Lean body mass assessed by the DEXA scan.

    The secondary outcomes will be assessed twice for each participant: one time before the training program and one time after the training program

  • Fat percentage measured using the skinfolds method and the DEXA scan.

    The secondary outcomes will be assessed twice for each participant: one time before the training program and one time after the training program

  • Hemoglobin mass measured using the CO rebreathing method.

    The secondary outcomes will be assessed twice for each participant: one time before the training program and one time after the training program

  • Hemoglobin concentration measured using the HORIBA hematology analyzer.

    The secondary outcomes will be assessed twice for each participant: one time before the training program and one time after the training program

  • +2 more secondary outcomes

Study Arms (4)

Normoxic group females

PLACEBO COMPARATOR

The participants in this group (12 females) will perform a repeated sprint training in normoxia.

Other: Repeated sprint training

Hypoxic group females

EXPERIMENTAL

The participants in this group (12 females) will perform a repeated sprint training in hypoxia.

Other: Repeated sprint training

Normoxic group males

PLACEBO COMPARATOR

The participants in this group (12 males) will perform a repeated sprint training in normoxia.

Other: Repeated sprint training

Hypoxic group males

PLACEBO COMPARATOR

The participants in this group (12 males) will perform a repeated sprint training in hypoxia.

Other: Repeated sprint training

Interventions

Participants will perform 7 weeks of cycling repeated sprint training (2x/week). Inspired oxygen fraction (FiO2) will be set to 14.6% and 20.9% for the hypoxic and normoxic group to simulate an altitude of 3000 m and 300 m, respectively. The training sessions will consist of a 10-min warm up followed by 3 sets of 5 x 10-s all-out repeated sprints on the cycle ergometer. The number of sets will decrease to two during week 7. Participants will be instructed to try to reach and maintain maximal power output during each sprint. An active recovery at 30% of VO2max will be allowed for 20 s between sprints and for 5 min between sets. The training will end with a 10-min cool down at 30% VO2max. An individual fixed torque of 0.7 will be used during the sprints and it will be reduced to 0.5 Nm/kg at week 7.

Hypoxic group femalesHypoxic group malesNormoxic group femalesNormoxic group males

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Females (on monophasic oral contraceptive pill)
  • Males
  • Must recreationally participating in team/racket sports min 3h/week with at least 2 years of experience prior to the study

You may not qualify if:

  • Smoking
  • Exposure to altitude \>1500 m one month before the study
  • Any health conditions or injuries that could compromise the participant's safety during training/testing
  • Prescribed medication
  • Performing repeated sprint training more than once per week.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise Physiology Lab

Louvain-la-Neuve, Brabant Walloon, 1348, Belgium

RECRUITING

Related Publications (2)

  • Faiss R, Leger B, Vesin JM, Fournier PE, Eggel Y, Deriaz O, Millet GP. Significant molecular and systemic adaptations after repeated sprint training in hypoxia. PLoS One. 2013;8(2):e56522. doi: 10.1371/journal.pone.0056522. Epub 2013 Feb 20.

    PMID: 23437154BACKGROUND
  • Costello JT, Bieuzen F, Bleakley CM. Where are all the female participants in Sports and Exercise Medicine research? Eur J Sport Sci. 2014;14(8):847-51. doi: 10.1080/17461391.2014.911354. Epub 2014 Apr 25.

    PMID: 24766579BACKGROUND

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Single blind, parallel, gender-comparative, randomized controlled study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2022

First Posted

June 30, 2022

Study Start

April 21, 2022

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

June 30, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations