ANZCTR - Registration

Registration number

ACTRN12621000425897

Ethics application status

Approved

Date submitted

4/02/2021

Date registered

16/04/2021

Date last updated

23/12/2021

Date data sharing statement initially provided

16/04/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

Menstrual cycle phase effects on performance and fatigue of team sport athletes

Scientific title

Menstrual Cycle Phase Effects on Performance and Maximal Rate of Heart Rate Increase in Eumenorrheic Team Sport Athletes

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Eumenorrhea

Condition category

Condition code

Reproductive Health and Childbirth

Menstruation and menopause

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Participation involves completing menstrual cycle diaries (to be completed daily to indicate whether menstrual bleeding has occurred and if any menstrual symptoms occur) throughout the during of the data collection period, which will last approximately 2-4 months depending on the participants menstrual cycle length and which phase of the menstrual cycle they will have their first testing session in.
Participants must also attend 3 testing sessions, 1 session in each of the 3 main phases of the menstrual cycle (early follicular, ovulatory and mid luteal), which are approximately 1-2 weeks apart (depending on menstrual cycle length). Testing sessions will take place in a laboratory at the University Campus and will be face-to-face, only participant will be tested at a time. 1 or 2 of the listed researchers and a maximum of 2 research assistants will be present at each testing session, and the sessions will be supervised by one of the listed researchers.
During every testing session, participants will have a venous blood sample collected by a trained researcher (or phlebotomist or nurse) - so serum estrogen and progesterone may be measured to confirm menstrual cycle phase - and complete subjective assessments including Athlete Sleep Screening Questionnaire and Recovery Stress Questionnaire for Athletes and muscle soreness visual analogue scale. Participants will then wear a heart rate monitor attached to chest strap, and complete the objective performance and fatigue testing which includes a 5 minute submaximal treadmill test - to allow for maximal rate of heart rate increase to be recorded, 3 trials of a countermovement jump test where participants will perform a maximal vertical jump (with 2 minutes of passive recovery provided between trials), isokinetic dynamometer testing including 3 trials assessing concentric hamstring and quadriceps peak toque and eccentric hamstring peak torque on the dominant and non-dominant limbs (with 30 seconds recovery between each trial) and one time trial will be conducted on a treadmill, where the participants controls treadmill speed and aims to complete 1500m as fast as possible. 2 minutes of rest will be provided between the countermovement jump, isokinetic testing and treadmill time trial.
Immediately following the treadmill time trial participants will provide a rating of perceived exertion and lie, quietly, in a supine position for 60 seconds - to allow for heart rate recovery to be recorded. Participants will then be allowed up in their own and remove the heart rate monitor and strap, and no further testing will be required until the next testing session.
It is estimated 1 entire testing session will take approximately 75 minutes; an introduction, the blood collection and completion of the subjective assessments will take approximately 25 minutes and completing the submaximal treadmill testing and jump test, isokinetic tests and 1500m time trial (including assessment of heart rate recovery post-time trial) will take 50-55 minutes.
Participants will be randomly assigned to one of 3 groups, these groups indicate which menstrual cycle phase participants will have their first testing session in. Randomisation will occur once participants are recruited and will be completed using MS Excel. Testing sessions will occur in consecutive phases and no washout period to allow a full cycle to elapse before the next session will be provided.

Intervention code [1]

Other interventions

Comparator / control treatment

The early follicular phase will be the comparator.

Control group

Active

Outcomes

Primary outcome [1]

Maximal rate of heart rate increase (rHRI) during 5 minutes of sub maximal treadmill running. The participant will wait on treadmill and when instructed they will start jogging at a speed between 7-8km/hr for 5 minutes. The participant may change the speed but it must remain between 7 and 8km/hr. The participant must wait on the treadmill for at least two minutes and no warning will be given about when the jogging will start to limit the participant's HR increasing in anticipation. At the end of five minutes the participant may slow to stop and have a minimum 2 minute rest before starting the jump testing. This outcome will be assessed using a HR monitor attached to a chest strap and the raw HR data will be entered into a premade spreadsheet to solve the rHRI.

Timepoint [1]

Early follicular phase

Primary outcome [2]

Maximal rate of heart rate increase (rHRI) during 5 minutes of sub maximal treadmill running. The participant will wait on treadmill and when instructed they will start jogging at a speed between 7-8km/hr for 5 minutes. The participant may change the speed but it must remain between 7 and 8km/hr. The participant must wait on the treadmill for at least two minutes and no warning will be given about when the jogging will start to limit the participant's HR increasing in anticipation. At the end of five minutes the participant may slow to stop and have a minimum 2 minute rest before starting the jump testing. This outcome will be assessed using a HR monitor attached to a chest strap and the raw HR data will be entered into a premade spreadsheet to solve the rHRI.

Timepoint [2]

Ovulatory phase

Primary outcome [3]

Maximal rate of heart rate increase (rHRI) during 5 minutes of sub maximal treadmill running. The participant will wait on treadmill and when instructed they will start jogging at a speed between 7-8km/hr for 5 minutes. The participant may change the speed but it must remain between 7 and 8km/hr. The participant must wait on the treadmill for at least two minutes and no warning will be given about when the jogging will start to limit the participant's HR increasing in anticipation. At the end of five minutes the participant may slow to stop and have a minimum 2 minute rest before starting the jump testing. This outcome will be assessed using a HR monitor attached to a chest strap and the raw HR data will be entered into a premade spreadsheet to solve the rHRI.

Timepoint [3]

Mid luteal phase

Secondary outcome [1]

Countermovement Jump Height (cm)
A countermovement jump test will be performed on a portable force plate. 3 trials separated by 2 minutes of recovery will be performed with the participant instructed to start from a stationary standing position on the force plate, with hands on hips and, in one motion, crouch down to a semi squatted position (self-selected squat depth) then spring up to the maximum height the subject can reach, keeping hands on hips and encourage soft landing with bent knees to absorb the force of the jump.

Timepoint [1]

Early follicular phase

Secondary outcome [2]

Countermovement Jump Height (cm)
A countermovement jump test will be performed on a portable force plate. 3 trials separated by 2 minutes of recovery will be performed with the participant instructed to start from a stationary standing position on the force plate, with hands on hips and, in one motion, crouch down to a semi squatted position (self-selected squat depth) then spring up to the maximum height the subject can reach, keeping hands on hips and encourage soft landing with bent knees to absorb the force of the jump.

Timepoint [2]

Ovulatory phase

Secondary outcome [3]

Countermovement Jump Height (cm)
A countermovement jump test will be performed on a portable force plate. 3 trials separated by 2 minutes of recovery will be performed with the participant instructed to start from a stationary standing position on the force plate, with hands on hips and, in one motion, crouch down to a semi squatted position (self-selected squat depth) then spring up to the maximum height the subject can reach, keeping hands on hips and encourage soft landing with bent knees to absorb the force of the jump.

Timepoint [3]

Mid luteal phase

Secondary outcome [4]

Countermovement Jump Peak Power
A countermovement jump test will be performed on a portable force plate. 3 trials separated by 2 minutes of recovery will be performed with the participant instructed to start from a stationary standing position on the force plate, with hands on hips and, in one motion, crouch down to a semi squatted position (self-selected squat depth) then spring up to the maximum height the subject can reach, keeping hands on hips and encourage soft landing with bent knees to absorb the force of the jump.

Timepoint [4]

Early follicular phase

Secondary outcome [5]

Countermovement Jump Peak Power
A countermovement jump test will be performed on a portable force plate. 3 trials separated by 2 minutes of recovery will be performed with the participant instructed to start from a stationary standing position on the force plate, with hands on hips and, in one motion, crouch down to a semi squatted position (self-selected squat depth) then spring up to the maximum height the subject can reach, keeping hands on hips and encourage soft landing with bent knees to absorb the force of the jump.

Timepoint [5]

Ovulatory phase

Secondary outcome [6]

Countermovement Jump Peak Power
A countermovement jump test will be performed on a portable force plate. 3 trials separated by 2 minutes of recovery will be performed with the participant instructed to start from a stationary standing position on the force plate, with hands on hips and, in one motion, crouch down to a semi squatted position (self-selected squat depth) then spring up to the maximum height the subject can reach, keeping hands on hips and encourage soft landing with bent knees to absorb the force of the jump.

Timepoint [6]

Mid luteal phase

Secondary outcome [7]

Countermovement Jump Flight time to Contraction time ratio
A countermovement jump test will be performed on a portable force plate. 3 trials separated by 2 minutes of recovery will be performed with the participant instructed to start from a stationary standing position on the force plate, with hands on hips and, in one motion, crouch down to a semi squatted position (self-selected squat depth) then spring up to the maximum height the subject can reach, keeping hands on hips and encourage soft landing with bent knees to absorb the force of the jump.

Timepoint [7]

Early follicular phase

Secondary outcome [8]

Countermovement Jump Flight time to Contraction time ratio
A countermovement jump test will be performed on a portable force plate. 3 trials separated by 2 minutes of recovery will be performed with the participant instructed to start from a stationary standing position on the force plate, with hands on hips and, in one motion, crouch down to a semi squatted position (self-selected squat depth) then spring up to the maximum height the subject can reach, keeping hands on hips and encourage soft landing with bent knees to absorb the force of the jump.

Timepoint [8]

Ovulatory phase

Secondary outcome [9]

Countermovement Jump Flight time to Contraction time ratio
A countermovement jump test will be performed on a portable force plate. 3 trials separated by 2 minutes of recovery will be performed with the participant instructed to start from a stationary standing position on the force plate, with hands on hips and, in one motion, crouch down to a semi squatted position (self-selected squat depth) then spring up to the maximum height the subject can reach, keeping hands on hips and encourage soft landing with bent knees to absorb the force of the jump.

Timepoint [9]

Mid luteal phase

Secondary outcome [10]

Quadriceps and Hamstring Peak Torque
An isokinetic dynamometer will be used to determine concentric hamstring and concentric quadriceps strength. 3 trials will be performed on the dominant and non-dominant limbs with 30 seconds of recovery between trials.

Timepoint [10]

Early follicular phase

Secondary outcome [11]

Quadriceps and Hamstring Peak Torque
An isokinetic dynamometer will be used to determine concentric hamstring and concentric quadriceps strength. 3 trials will be performed on the dominant and non-dominant limbs with 30 seconds of recovery between trials.

Timepoint [11]

Ovulatory phase

Secondary outcome [12]

Quadriceps and Hamstring Peak Torque
An isokinetic dynamometer will be used to determine concentric hamstring and concentric quadriceps strength. 3 trials will be performed on the dominant and non-dominant limbs with 30 seconds of recovery between trials.

Timepoint [12]

Mid luteal phase

Secondary outcome [13]

1500m Running Time
Endurance capacity will be measured as the time taken (minutes) to complete 1500m on a treadmill, time will be recorded on the treadmill and stopwatch in case of technical errors, that prevent time from being recorded. The participant will self-select the speed on the treadmill and instructed to reach the 1500m as fast as possible. Participants will be blinded to the time on the treadmill and only able to see the distance covered.

Timepoint [13]

Early follicular phase

Secondary outcome [14]

1500m Running Time
Endurance capacity will be measured as the time taken (minutes) to complete 1500m on a treadmill, time will be recorded on the treadmill and stopwatch in case of technical errors, that prevent time from being recorded. The participant will self-select the speed on the treadmill and instructed to reach the 1500m as fast as possible. Participants will be blinded to the time on the treadmill and only able to see the distance covered.

Timepoint [14]

Ovulatory phase

Secondary outcome [15]

1500m Running Time
Endurance capacity will be measured as the time taken (minutes) to complete 1500m on a treadmill, time will be recorded on the treadmill and stopwatch in case of technical errors, that prevent time from being recorded. The participant will self-select the speed on the treadmill and instructed to reach the 1500m as fast as possible. Participants will be blinded to the time on the treadmill and only able to see the distance covered.

Timepoint [15]

Mid luteal phase

Secondary outcome [16]

Sleep quality
The Athlete Sleep Screening Questionnaire will be competed by participants at the start of the testing session. Sleep quality will recorded as the score derived from the Athlete Sleep Screening Questionnaire scoring sheet.

Timepoint [16]

Early follicular phase

Secondary outcome [17]

Sleep quality
The Athlete Sleep Screening Questionnaire will be competed by participants at the start of the testing session. Sleep quality will recorded as the score derived from the Athlete Sleep Screening Questionnaire scoring sheet.

Timepoint [17]

Ovulatory phase

Secondary outcome [18]

Sleep quality
The Athlete Sleep Screening Questionnaire will be competed by participants at the start of the testing session. Sleep quality will recorded as the score derived from the Athlete Sleep Screening Questionnaire scoring sheet.

Timepoint [18]

Mid luteal phase

Secondary outcome [19]

Muscle soreness
The muscle soreness visual analogue scale is also completed at the start of testing sessions, soreness will be recorded as the distance of the participant's mark on scale to the start of the scale (mm).

Timepoint [19]

Early follicular phase

Secondary outcome [20]

Muscle soreness
The muscle soreness visual analogue scale is also completed at the start of testing sessions, soreness will be recorded as the distance of the participant's mark on scale to the start of the scale (mm).

Timepoint [20]

Ovulatory phase

Secondary outcome [21]

Muscle soreness
The muscle soreness visual analogue scale is also completed at the start of testing sessions, soreness will be recorded as the distance of the participant's mark on scale to the start of the scale (mm).

Timepoint [21]

Mid luteal phase

Secondary outcome [22]

Recovery-Stress
The 52 item Recovery-stress Questionnaire for Athletes will also be competed by participants at the start of the testing session. A score will be provided using the User Manual

Timepoint [22]

Early follicular phase

Secondary outcome [23]

Recovery-Stress
The 52 item Recovery-stress Questionnaire for Athletes will also be competed by participants at the start of the testing session. A score will be provided using the User Manual

Timepoint [23]

Ovulatory phase

Secondary outcome [24]

Recovery-Stress
The 52 item Recovery-stress Questionnaire for Athletes will also be competed by participants at the start of the testing session. A score will be provided using the User Manual

Timepoint [24]

Mid luteal phase

Secondary outcome [25]

Rating of Perceived Exertion
Immediately following the treadmill time trial, participants will be shown a 0-10 rating of perceived exertion scale and their response 0-10 will be recorded.

Timepoint [25]

Early follicular phase

Secondary outcome [26]

Rating of Perceived Exertion
Immediately following the treadmill time trial, participants will be shown a 0-10 rating of perceived exertion scale and their response 0-10 will be recorded.

Timepoint [26]

Ovulatory phase

Secondary outcome [27]

Rating of Perceived Exertion
Immediately following the treadmill time trial, participants will be shown a 0-10 rating of perceived exertion scale and their response 0-10 will be recorded.

Timepoint [27]

Mid luteal phase

Secondary outcome [28]

Heart rate recovery
Participants must also lie down quietly, immediately following the time trial, for at least 60 seconds. Using the heart rate data collected from the heart rate monitor worn throughout testing, heart rate recovery will be measured as the difference in heart rate at the end of the time trial and 60 seconds after the end of the time trial.

Timepoint [28]

Early follicular phase

Secondary outcome [29]

Heart rate recovery
Participants must also lie down quietly, immediately following the time trial, for at least 60 seconds. Using the heart rate data collected from the heart rate monitor worn throughout testing, heart rate recovery will be measured as the difference in heart rate at the end of the time trial and 60 seconds after the end of the time trial.

Timepoint [29]

Ovulatory phase

Secondary outcome [30]

Heart rate recovery
Participants must also lie down quietly, immediately following the time trial, for at least 60 seconds. Using the heart rate data collected from the heart rate monitor worn throughout testing, heart rate recovery will be measured as the difference in heart rate at the end of the time trial and 60 seconds after the end of the time trial.

Timepoint [30]

Mid luteal phase

Eligibility

Key inclusion criteria

Female
Field-based team sport athlete
Aged 18 to 45
Menstrual cycle length between 21 and 35 days (eumenorrheic)
Considered low risk to exercise based on pre-exercise screening tool
Have not used any hormonal contraception in the last three months

Minimum age

18 Years

Maximum age

45 Years

Sex

Females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Amenorrheic (have never menstruated or have not menstruated for last 3 months)
Perimenopausal or menopausal
Polymenorrheic (menstrual cycle length less than 21 days)
Oligomenorrheic (menstrual cycle length more than 35 days)
Hormonal contraceptive use in last three months
Male

Study design

Statistical methods / analysis

Linear mixed models

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

30/04/2021

Actual

27/05/2021

Date of last participant enrolment

Anticipated

30/03/2022

Actual

Date of last data collection

Anticipated

31/05/2022

Actual

Sample size

Target

40

Accrual to date

3

Final

Recruitment in Australia

Recruitment state(s)

SA

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of South Australia

Country [1]

Australia

Primary sponsor type

University

Name

University of South Australia

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Tom Wycherley

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

UniSA Human Research Ethics Committee

Ethics committee address [1]

GPO Box 2471, Adelaide, South Australia 5001

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

21/09/2020

Approval date [1]

28/01/2021

Ethics approval number [1]

203420

Summary

Brief summary

A better understanding of how performance and fatigue are affected by the hormonal fluctuations in different menstrual cycle phases will ensure coaches and sport scientists can make informed and evidenced based decisions relating to the training, recovery and monitoring of female field-based, team sport athletes. This study primarily aims to determine whether physical performance (in countermovement jump, concentric hamstring and quadriceps strength, and 1500m treadmill time trial tests) and markers of fatigue status (maximal rate of heart rate increase, 60s heart rate recovery and ratings of perceived exertion, and responses to the Athlete Sleep Screening Questionnaire and Recovery Stress Questionnaire for Athletes) are affected by menstrual cycle phase. Additionally, it aims to determine whether a change in subjective fatigue correlates to a change in objective fatigue, and if either subjective or objective fatigue correlate to a change in performance.

Trial website

Public notes

Contacts

Principal investigator

Name

Miss Mikaeli Carmichael

Address

University of South Australia, Level 2, Playford Building, North Terrace, Adelaide SA 5001

Country

Australia

Phone

+61 4 39349863

Email

[email protected]

Contact person for public queries

Name

Miss Mikaeli Carmichael

Address

University of South Australia, Level 2, Playford Building, North Terrace, Adelaide SA 5001

Country

Australia

Phone

+61 4 39349863

Email

[email protected]

Contact person for scientific queries

Name

Miss Mikaeli Carmichael

Address

University of South Australia, Level 2, Playford Building, North Terrace, Adelaide SA 5001

Country

Australia

Phone

+61 4 39349863

Email

[email protected]

Trial Review

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