NCT06634134

Brief Summary

With an increase in number of female athletes in sport events, it is becoming more important to gain insight in female related sports physiology. A main difference between male anf female athletes is the menstrual cycle. During the menstrual cycle, female reproductive hormones fluctuate. These hormones are also of influence on endurance, recovery, muscle strenght and mental state. Therefore we hypothesize that training efficiancy, power and motivation to train differ during the menstrual cycle. In case there is a pattern seen during the menstrual cycle, training programs can be individualized taking the menstrual cycle into account leading to more effective training programs.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Oct 2024

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

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 Progress49%
Oct 2024Jan 2028

First Submitted

Initial submission to the registry

August 15, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 9, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

October 10, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Expected
Last Updated

July 28, 2025

Status Verified

July 1, 2025

Enrollment Period

1.2 years

First QC Date

August 15, 2024

Last Update Submit

July 24, 2025

Conditions

Keywords

Menstrual CycleArtificial IntelligenceCyclingFemale Athlete TriadFemale AthletesMenstrual Cycle-based Periodized training

Outcome Measures

Primary Outcomes (3)

  • Health of menstrual cycle in amateur cyclist

    It is known that the incidence of amenorrhea is about 15% of the professional female athletes. This has many short- and long term health consequences. These health consequences can be avoided since developing amenorrhea is preventable. It is unknown how many amateur cyclist have an irregular period or have amenorrhea. Insight in the size of this health problem creates a window of opportunity in preventive medicine.

    1 year

  • Objective training parameters during the menstral cycle

    By collecting details in regards to the menstrual cycle in combination with objective parameters (heart rate, power, speed, endurance) of training it is possible to investigate whether these objective parameters are influenced by the hormonal fluctuations during the menstrual cycle.

    2 years

  • Subjective training parameters during the menstrual cycle

    By collecting details in regards to the menstrual cycle in combination with subjective parameters (fatigue, discomfort, readiness, motivation) of training it is possible to investigate whether these subjective parameters are influenced by the hormonal fluctuations during the menstrual cycle.

    2 years

Secondary Outcomes (2)

  • Is menstrual cycle-based periodized training feasible in the future?

    2 years

  • Does the menstrual cycle affect recovery?

    2 years

Other Outcomes (2)

  • Questionnaires

    3 years

  • Excercise testing

    3 years

Study Arms (1)

Female cyclist

All female cyclist that consent using the data collected by JOIN cycling app and also give permission tracking thier menstrual cycle. Natrual menstrual cycle. Hormonal contraceptive use Intra-uterine device use (hormonal vs non-hormonal)

Behavioral: Adjusting training advice

Interventions

Based on discomfort related to the menstrual cycle the female cyclist can choose to adjust the suggested training.

Female cyclist

Eligibility Criteria

Age12 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Female JOIN cycling app members that consent with tracking the menstrual cycle.

You may qualify if:

  • JOIN cycling app member
  • female cyclist
  • informed consent period tracking in JOIN

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Martini Ziekenhuis

Groningen, 9728 NZ, Netherlands

NOT YET RECRUITING

Martini ziekenhuis

Groningen, 9728 NZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Female Athlete Triad Syndrome

Condition Hierarchy (Ancestors)

Relative Energy Deficiency in SportFeeding and Eating DisordersMental Disorders

Central Study Contacts

Anne Marijn van der Graaf, MD/PhD

CONTACT

Margot Verleg

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2024

First Posted

October 9, 2024

Study Start

October 10, 2024

Primary Completion

January 1, 2026

Study Completion (Estimated)

January 1, 2028

Last Updated

July 28, 2025

Record last verified: 2025-07

Locations