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Trial registered on ANZCTR


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] 302848 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eumenorrhea 320608 0
Condition category
Condition code
Reproductive Health and Childbirth 317772 317772 0 0
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] 320162 0
Other interventions
Comparator / control treatment
The early follicular phase will be the comparator.
Control group
Active

Outcomes
Primary outcome [1] 325797 0
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] 325797 0
Early follicular phase
Primary outcome [2] 326421 0
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] 326421 0
Ovulatory phase
Primary outcome [3] 326422 0
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] 326422 0
Mid luteal phase
Secondary outcome [1] 393616 0
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] 393616 0
Early follicular phase
Secondary outcome [2] 393617 0
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] 393617 0
Ovulatory phase
Secondary outcome [3] 393618 0
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] 393618 0
Mid luteal phase
Secondary outcome [4] 393619 0
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] 393619 0
Early follicular phase
Secondary outcome [5] 393620 0
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] 393620 0
Ovulatory phase
Secondary outcome [6] 393621 0
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] 393621 0
Mid luteal phase
Secondary outcome [7] 393622 0
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] 393622 0
Early follicular phase
Secondary outcome [8] 393623 0
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] 393623 0
Ovulatory phase
Secondary outcome [9] 393624 0
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] 393624 0
Mid luteal phase
Secondary outcome [10] 393625 0
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] 393625 0
Early follicular phase
Secondary outcome [11] 393626 0
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] 393626 0
Ovulatory phase
Secondary outcome [12] 393627 0
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] 393627 0
Mid luteal phase
Secondary outcome [13] 393628 0
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] 393628 0
Early follicular phase
Secondary outcome [14] 393629 0
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] 393629 0
Ovulatory phase
Secondary outcome [15] 393630 0
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] 393630 0
Mid luteal phase
Secondary outcome [16] 393631 0
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] 393631 0
Early follicular phase
Secondary outcome [17] 393632 0
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] 393632 0
Ovulatory phase
Secondary outcome [18] 393633 0
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] 393633 0
Mid luteal phase
Secondary outcome [19] 393634 0
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] 393634 0
Early follicular phase
Secondary outcome [20] 393635 0
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] 393635 0
Ovulatory phase
Secondary outcome [21] 393636 0
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] 393636 0
Mid luteal phase
Secondary outcome [22] 393637 0
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] 393637 0
Early follicular phase
Secondary outcome [23] 393638 0
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] 393638 0
Ovulatory phase
Secondary outcome [24] 393639 0
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] 393639 0
Mid luteal phase
Secondary outcome [25] 393640 0
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] 393640 0
Early follicular phase
Secondary outcome [26] 393641 0
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] 393641 0
Ovulatory phase
Secondary outcome [27] 393642 0
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] 393642 0
Mid luteal phase
Secondary outcome [28] 393643 0
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] 393643 0
Early follicular phase
Secondary outcome [29] 393644 0
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] 393644 0
Ovulatory phase
Secondary outcome [30] 393645 0
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] 393645 0
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
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
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] 307269 0
University
Name [1] 307269 0
University of South Australia
Country [1] 307269 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
Corner of North Terrace and, Frome Rd, Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 307893 0
Individual
Name [1] 307893 0
Tom Wycherley
Address [1] 307893 0
University of South Australia, Playford Building, corner North Terrace and Frome Rd, Adelaide SA 5001
Country [1] 307893 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307366 0
UniSA Human Research Ethics Committee
Ethics committee address [1] 307366 0
Ethics committee country [1] 307366 0
Australia
Date submitted for ethics approval [1] 307366 0
21/09/2020
Approval date [1] 307366 0
28/01/2021
Ethics approval number [1] 307366 0
203420

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106978 0
Miss Mikaeli Carmichael
Address 106978 0
University of South Australia, Level 2, Playford Building, North Terrace, Adelaide SA 5001
Country 106978 0
Australia
Phone 106978 0
+61 4 39349863
Fax 106978 0
Email 106978 0
mikaeli.carmichael@mymail.unisa.edu.au
Contact person for public queries
Name 106979 0
Mikaeli Carmichael
Address 106979 0
University of South Australia, Level 2, Playford Building, North Terrace, Adelaide SA 5001
Country 106979 0
Australia
Phone 106979 0
+61 4 39349863
Fax 106979 0
Email 106979 0
mikaeli.carmichael@mymail.unisa.edu.au
Contact person for scientific queries
Name 106980 0
Mikaeli Carmichael
Address 106980 0
University of South Australia, Level 2, Playford Building, North Terrace, Adelaide SA 5001
Country 106980 0
Australia
Phone 106980 0
+61 4 39349863
Fax 106980 0
Email 106980 0
mikaeli.carmichael@mymail.unisa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified raw data collected during study (including outcomes from testing sessions and serum hormone concentrations).
When will data be available (start and end dates)?
Immediately following publication; no end date determined.
Available to whom?
Anyone who contacts the researchers and makes a reasonable request to access the data.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Access is subject to approvals by Principal Investigator (mikaeli.carmichael@mymail.unisa.edu.au)


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.