NCT05936424

Brief Summary

The primary purpose of this study is to employ state-of-the-art methods to fill current knowledge gaps on the effects of the menstrual cycle on resistance exercise training adaptations. This work will reduce the sex gap present in exercise physiology, improving women's health information by yielding a deeper understanding of the effect of female physiology on exercise adaptations and subsequent health benefits. Employing a unilateral training design, participant's will have their legs randomized to one of four groups: non-exercise control (CON), exercise control (EX), Follicular based training (FOL), Luteal based training (LUT) Researchers will compare these conditions to see if there are greater benefits to prioritizing resistance training around phases of the menstrual cycle,

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 7, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2024

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

August 22, 2025

Status Verified

August 1, 2025

Enrollment Period

1.2 years

First QC Date

June 22, 2023

Last Update Submit

August 18, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Muscle Hypertrophy

    The investigators will be measuring participant's muscle cross-sectional area of the quadriceps pre and post training intervention via ultrasound (US) US is used to measure skeletal muscle thickness and cross-sectional area. A trained and experienced study investigator will perform the US measures. US will be used to measure the cross-sectional area of the vastus lateralis muscle on both legs. After remaining supine for 15-minute, your feet will be positioned in a custom foot-hold apparatus that prevents depression of the thigh against the bed. Mid-thigh will be identified via palpation. A marker will be used to draw a line down your leg, perpendicular to the surface of the bed, and horizontal markings will be made every 2 cm serving as a guideline for ultrasound probe placement. Ultrasound images will be taken at each horizontal marking and used to measure the muscle cross-sectional area of the quadriceps.

    16 weeks

  • Muscular Strength

    The investigators will be measuring participant's muscle strength via one-repetition maximum testing using the unilateral leg press.

    16 Weeks

Study Arms (4)

Non-Exercise Control (CON)

ACTIVE COMPARATOR

This condition will serve as a non-exercise control and will not be performing resistance exercise training (RET)

Other: Non-Exercise Control Leg

Follicular Based Training (FOL)

EXPERIMENTAL

This condition will have high volume of RET (20 weekly sets) during the follicular phase and low volume during the luteal phase of the participant's menstrual cycle.

Other: Unilateral Resistance Exercise Leg

Luteal Based Training (LUT)

EXPERIMENTAL

This condition will have high volume of RET (20 weekly sets) during the luteal phase and low volume during the follicular phase of the participant's menstrual cycle.

Other: Unilateral Resistance Exercise Leg

Exercise Control (EX)

EXPERIMENTAL

This condition will have consistent training volume (12 weekly sets) throughout the duration of the study, regardless of what phase of the menstrual cycle the participant is in.

Other: Unilateral Resistance Exercise Leg

Interventions

One will perform unilateral resistance exercise

Exercise Control (EX)Follicular Based Training (FOL)Luteal Based Training (LUT)

One leg will serve as a non-exercise control

Non-Exercise Control (CON)

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women, between the ages of 18 - 30 years (inclusive)
  • Have a body mass index (BMI) between 18-35 kg·m2 (inclusive)
  • Be in general good health as assessed by a general health questionnaire
  • Non-smoking
  • Regular menstrual cycle (21-35 days, inclusive)
  • Not using hormonal contraceptives
  • Willing and able to provide informed consent

You may not qualify if:

  • Use of tobacco or related products.
  • Ineligible to participate in physical activity based on get active questionnaire (GAQ)
  • Any concurrent medical, orthopedic, or psychiatric condition that, in the opinion of the Investigator, would compromise his/her ability to comply with the study requirements.
  • Current illnesses which could interfere with the study (e.g. prolonged severe diarrhea, regurgitation, difficulty swallowing)
  • Use of hormonal contraceptives
  • Currently pregnant
  • Training more than 3x/week for the past 6 months.
  • Have any electronic medical or metal implants
  • A history of neuromuscular disorders or muscle/bone wasting diseases
  • The use of any medications known to affect protein metabolism (glucocorticoids, non-steroidal anti-inflammatory medication, or prescription strength acne medication, etc.)
  • A (family) history of thrombosis
  • The use of anticoagulant medications
  • Excessive alcohol consumption (\>21 units/wk)
  • History of bleeding diathesis, platelet or coagulation disorders, or antiplatelet/anticoagulation therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise Metabolism Research Laboratory, McMaster Univeristy

Hamilton, Ontario, L8S 4K1, Canada

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
As this is a resistance exercise training intervention, participants will be unable to be masked to their treatment condition.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomized controlled trial (RCT), within-between subject design. Legs will be randomized to one of four groups: non-exercise control (CON), exercise control (EX), Follicular based training (FOL), Luteal based training (LUT)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 22, 2023

First Posted

July 7, 2023

Study Start

September 1, 2023

Primary Completion

November 15, 2024

Study Completion

November 30, 2024

Last Updated

August 22, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

All participants will be assigned a unique subject identification number (ID), and therefore, other researchers involved with analyses will not have access to identifying participant information.

Locations