NCT07581067

Brief Summary

The existing literature examining the effect of female sex hormones across the phases of the menstrual cycle on muscle microdamage and oxygen uptake is limited. The protective role of estrogens against muscle microdamage is supported by findings from some studies; however, it is questioned by others. The aim of the present study was to investigate the effect of eccentric exercise on biomarkers of muscle microdamage and on oxygen uptake during two phases of the menstrual cycle in healthy premenopausal women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

May 15, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 12, 2026

Completed
Last Updated

May 15, 2026

Status Verified

May 1, 2026

Enrollment Period

3 months

First QC Date

May 6, 2026

Last Update Submit

May 13, 2026

Conditions

Keywords

Eccentric exerciseExercise induced muscle damage

Outcome Measures

Primary Outcomes (4)

  • Maximal isometric torque

    maximal performance during 5 sec isometric knee extensors contraction, assessed pre and 48 h post eccentric exercise

    From enrollment to the end of the intervention at 2 weeks

  • Delayed onset muscle soreness

    Palpation of the muscle belly, performed pre and 48h post eccentric exercise

    From enrollment to the end of intervention at 2 weeks

  • Oxygen consumption

    During the isokinetic eccentric exercise, participants were attached to a gas analyser for continuously measuring oxygen consumption.

    From enrollment to the end of the intervention at 2 weeks

  • Duration of the isokinetic exercise

    The total duration of exercise performed on the isokinetic dynamometer was recorded

    From enrollment to the end of intervention at 2 weeks

Study Arms (1)

Eccentric exercise

EXPERIMENTAL

A group of female subjects performed an exercise with one leg and an exercise with the other leg, separated by 2 weeks. Before and 2 days after the exercise sessions, performance was assessed.

Other: Isokinetic eccentric exercise using knee extensors of the right lower limbOther: Isokinetic eccentric exercise using knee extensors of the left lower limb

Interventions

Isokinetic eccentric exercise consisted of 10 min at 40% of maximal voluntary contractions, followed by 2 min maximal intensity muscle effort

Eccentric exercise

Isokinetic eccentric exercise consisted of 10 min at 40% of maximal voluntary contractions, followed by 2 min maximal intensity muscle effort

Eccentric exercise

Eligibility Criteria

Age18 Years - 28 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemales with normal menstrual cycle
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • No known medical history
  • Not receiving any medication or dietary supplementation.
  • Stable menstrual cycle

You may not qualify if:

  • Pathological conditions the last month before enrolment in the study
  • Low limb injury the past 4 months
  • Unstable menstrual cycle

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Educaiton and Sport Science

Dafni, Attica, 17234, Greece

Location

Study Officials

  • Vassilis Paschalis, PhD

    National and Kapodistrian University of Athens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 6, 2026

First Posted

May 12, 2026

Study Start

May 15, 2025

Primary Completion

August 5, 2025

Study Completion

January 22, 2026

Last Updated

May 15, 2026

Record last verified: 2026-05

Locations