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Clinical Trials/CTRI/2025/01/079815
CTRI/2025/01/079815CompletedNot Applicable

Impact of menstrual cycle phases on fitness determining physiological variables among sub-elite eumenorrheic athletes.

Hema Nandini T N1 site in 1 country18 target enrollmentStarted: February 10, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
18
Locations
1
Primary Endpoint
Physiological fitness variables

Study Overview

Brief Summary

Primary objective: Impact of menstrual cycle (MC) phases on psychological measures pre and post a constant test plan among sub-elite eumenorrheic athletes.

Justification for study: Fewer research has been conducted to understand the impact of MC phases on psychological measures among sub-elite eumenorrheic athletes. This study will help the coaches and athletes to tailor the training program at par with the MC phases and related symptoms.

The study will be conducted after obtaining permission from the IRC and IEC approval, CTRI registration, and approval will be obtained.

Subjects will be enrolled based on inclusion and exclusion criteria. The participants will be volunteering for the study.

An informed consent form will be explained, and a signed consent form will be obtained for approval.

On the first visit, demographic, sports-related, health-related, height, and body mass details will be taken.

On the same visit, participants are explained about the procedure and familiarized with the protocol.

The time (plus or minus 2 hours of the initial testing session), dietary intake, and nutritional supplements will be standardized or repeated during the testing period, and all will be informed to the participants on the same day.

Before beginning the testing protocol, they will be required to complete the questionnaire (1), which is a pre-test questionnaire. After completing the questionnaire, participants will be asked to perform a series of tests. The tests will include assessments for Flexibility (Sit and Reach test), Muscular Endurance (Push-ups, Partial curl-ups), Anaerobic capacity (Wingate test), Muscle Power (Counter Movement Jump), and Agility (Illinois test). Following the tests, participants will be asked to complete a post-test questionnaire. This process will be repeated on nine separate visits over three months, and participants will be reminded of this protocol before each test.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 35.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • Average menstrual cycle length 21 to 35 days (eumenorrheic).
  • Actively training for their respective sports for at least 6 months or more.
  • Athlete is training for more than 5 hours per week.
  • Sub-elite athletes (One who train any sport for 5 to 6 hours in a week and one who play district and state level competitions).

Exclusion Criteria

  • Uses hormonal contraceptives (currently or within the past 3 months).
  • Diagnosed with a menstrual disorder.
  • Diagnosed with an eating disorder.
  • Currently having musculoskeletal or neurological abnormalities or chronic illness.
  • Having any injury that interferes with training or could risk participation.

Outcomes

Primary Outcomes

Physiological fitness variables

Time Frame: Duration is 3 months, where there will be 3 sessions per month.

Secondary Outcomes

  • Not applicable(Not applicable)

Investigators

Sponsor
Hema Nandini T N
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Hema Nandini T N

Manipal college of health professions

Study Sites (1)

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