NCT07322874

Brief Summary

The aim of the study is to investigate the effect of the different menstrual cycle phases on the recovery from exercise-induced muscle injury in eumenorrheic women. For this purpose, in a cross-over, randomized study, at least 10 healthy eumenorrheic women aged 18-35 years will participate. In a random order, the participants will perform 45 min downhill (-15% slope) running on a treadmill at 70% HRmax followed by a maximal time-trial (95% HRmax) to exhaustion: i) during the follicular phase and ii) during the luteal phase. Before the exercise protocol, as well as at 24 h, 48 h and 72 h following exercise, complete blood count, delayed onset of muscle soreness (DOMS), creatine kinase activity, countermovement jump, isometric, concentric and eccentric strength of knee extensors and knee flexors, will be assessed. In addition, lactic acid concentration will be assessed before and immediately following exercise, and DOMS will be assessed immediately after the end of exercise. Following a washout period of ≥28 days (depending on the length of the menstrual cycle), participants will repeat the exact same procedure for the remaining phase of the menstrual cycle.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 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

March 1, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2025

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 7, 2026

Completed
Last Updated

February 3, 2026

Status Verified

February 1, 2026

Enrollment Period

10 months

First QC Date

December 7, 2025

Last Update Submit

February 1, 2026

Conditions

Keywords

menstrual cyclefollicular phaseluteal phaseexercise-induced muscle damagemuscle performancemuscle soreness

Outcome Measures

Primary Outcomes (6)

  • Changes in Creatine kinase (CK) activity

    CK activity will be measured in plasma using a Clinical Chemistry Analyzer with commercially available kits.

    At baseline (pre), post-, 24 hours post-, 48 hours post-, 72 hours post-trial

  • Changes in delayed onset of muscle soreness (DOMS)

    DOMS of knee extensors, knee flexors, gluteal and gastrocnemius muscles of both lower extremities will be measured during palpation of the muscle belly and the distal region after performing three repetitions of a full squat.

    At baseline (pre), post-, 24 hours post-, 48 hours post-, 72 hours post-tria

  • Changes in blood lactate concentration

    Lactate concentration will be measured in capillary blood with a hand-portable analyzer

    At baseline (pre), 4 minutes post-exercise

  • Changes in countermovement jump (CMJ) height

    CMJ height will be measured with an optical system. Participants will perform 3 maximal CMJ jumps and the best effort will be recorded

    At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise

  • Changes in isokinetic strength of knee extensors (KE) and knee flexors (KF)

    Isometric, concentric and eccentric peak torque of the KE and KF of both limbs will be assessed on an isokinetic dynamometer

    At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise

  • Changes in complete blood count (CBC)

    CBC (white blood cells, erythrocytes, platelets) will be measured in an hematological analyzer with commercially available reagents

    At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise

Secondary Outcomes (7)

  • Differences in Estradiol concentration between trials

    At late-follicular and mid-luteal phase (according to each participant's menstrual cycle length), before exercise

  • Differences in Progesterone concentration between trials

    At late-follicular and mid-luteal phase (according to each participant's menstrual cycle length), before exercise

  • Body weight

    At late-follicular and mid-luteal phase (according to each participant's menstrual cycle length), before exercise

  • Body height

    At late-follicular and mid-luteal phase (according to each participant's menstrual cycle length), before exercise

  • Body mass index (BMI)

    At late-follicular and mid-luteal phase (according to each participant's menstrual cycle length), before exercise

  • +2 more secondary outcomes

Study Arms (2)

Follicular phase

EXPERIMENTAL

The participants will perform downhill running (-15% slope) on a treadmill at 70% of HRmax followed by running on a horizontal level (0% slope) at 95% HRmax until exhaustion, during the follicular phase

Other: Exercise during follicular phase

Luteal phase

EXPERIMENTAL

The participants will perform downhill running (-15% slope) on a treadmill at 70% of HRmax followed by running on a horizontal level (0% slope) at 95% HRmax until exhaustion, during the luteal phase

Other: Exercise during luteal phase

Interventions

The participants will perform downhill running (-15% slope) on a treadmill at 70% of HRmax followed by running on a horizontal level (0% slope) at 95% HRmax until exhaustion, during the follicular phase

Follicular phase

The participants will perform downhill running (-15% slope) on a treadmill at 70% of HRmax followed by running on a horizontal level (0% slope) at 95% HRmax until exhaustion, during the luteal phase

Luteal phase

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Physically active subjects (VO2max ≥35ml/kg/min)
  • Absence of musculoskeletal injury (≥6 months)
  • Abstinence from the use of ergogenic supplements (≥1 month)
  • Abstinence from anti-inflammatory drugs (≥1 month)
  • Abstinence from participating in exercise with eccentric content for at least 7 days before exercise
  • Abstinence from alcohol and energy drinks before exercise

You may not qualify if:

  • Recent history of musculoskeletal injury (\<6 months)
  • Use of ergogenic performance supplements (\<1 month)
  • Taking anti-inflammatory drugs (\<1 month)
  • Participation in exercise with eccentric content in the previous 7 days before exercise
  • Consumption of alcohol and energy drinks before exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Education and Sport Science, University of Thessaly

Trikala, Thessaly, 42100, Greece

Location

Related Publications (6)

  • Roepstorff C, Steffensen CH, Madsen M, Stallknecht B, Kanstrup IL, Richter EA, Kiens B. Gender differences in substrate utilization during submaximal exercise in endurance-trained subjects. Am J Physiol Endocrinol Metab. 2002 Feb;282(2):E435-47. doi: 10.1152/ajpendo.00266.2001.

    PMID: 11788377BACKGROUND
  • Romero-Parra N, Cupeiro R, Alfaro-Magallanes VM, Rael B, Rubio-Arias JA, Peinado AB, Benito PJ; IronFEMME Study Group. Exercise-Induced Muscle Damage During the Menstrual Cycle: A Systematic Review and Meta-Analysis. J Strength Cond Res. 2021 Feb 1;35(2):549-561. doi: 10.1519/JSC.0000000000003878.

    PMID: 33201156BACKGROUND
  • Ruby BC, Coggan AR, Zderic TW. Gender differences in glucose kinetics and substrate oxidation during exercise near the lactate threshold. J Appl Physiol (1985). 2002 Mar;92(3):1125-32. doi: 10.1152/japplphysiol.00296.2001.

    PMID: 11842049BACKGROUND
  • Oosthuyse T, Strauss JA, Hackney AC. Understanding the female athlete: molecular mechanisms underpinning menstrual phase differences in exercise metabolism. Eur J Appl Physiol. 2023 Mar;123(3):423-450. doi: 10.1007/s00421-022-05090-3. Epub 2022 Nov 19.

    PMID: 36402915BACKGROUND
  • D'Eon TM, Sharoff C, Chipkin SR, Grow D, Ruby BC, Braun B. Regulation of exercise carbohydrate metabolism by estrogen and progesterone in women. Am J Physiol Endocrinol Metab. 2002 Nov;283(5):E1046-55. doi: 10.1152/ajpendo.00271.2002.

    PMID: 12376334BACKGROUND
  • Ose BM, Eisenhauer J, Roepe I, Herda AA, Vopat BG, Vopat LM. Where Are All the Female Participants in Sports and Exercise Medicine Research? A Decade Later. Am J Sports Med. 2025 Jul;53(8):2022-2028. doi: 10.1177/03635465241278350. Epub 2025 Jan 9.

    PMID: 39780766BACKGROUND

MeSH Terms

Conditions

Myalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesMusculoskeletal PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Chariklia K Deli, Associate Professor, MSc, PhD

    University of Thessaly

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 7, 2025

First Posted

January 7, 2026

Study Start

March 1, 2025

Primary Completion

December 30, 2025

Study Completion

December 30, 2025

Last Updated

February 3, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations