Menstrual Cycle Phase Based Training

NCT ID: NCT05936424

Last Updated: 2025-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2024-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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,

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Participants will be required to track their menstrual cycle (MC) for a total of four MC's. MC tracking will be done via self-reported menstrual onset and ovulation strips. During the first tracking cycle participants will be asked to come in at three time points for blood draws to confirm hormone concentrations and familiarize them with the strength testing protocol. Following the tracking month participant legs will then be blocked randomized based on leg skeletal muscle mass and strength into one of four groups: non-exercise control (CON), exercise control (EX), follicular based training (FOL) and luteal based training (LUT). Participants will then be asked to come in \~2x per week (4-6x/menstrual cycle phase) for resistance training under direct supervision. Participants will be trained in unilateral leg extension and unilateral leg press. For legs randomized to the FOL and LUT group, training volume will be manipulated by changing the number of sets completed. The FOL group will train high volume (\~20+ sets per week) in their follicular phase and low volume (\~5 sets/week) in their luteal phase, the opposite will be true for the LUT group. Muscle biopsies will be taken both prior to and after training to assess changes in fiber cross-sectional area (CSA) and capillarization. Segmental body composition will be assessed both prior and post training using bioelectrical impedance analysis (BIA), dual x-ray absorptiometry (DXA), and vastus lateralis cross-sectional area and thickness. Muscle strength will also be assessed pre and post training using the isokinetic dynamometer, unilateral one-repetition maximum (1RM) leg extension and unilateral 1RM leg press.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Menstrual Cycle Resistance Exercise

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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)
Primary Study Purpose

OTHER

Blinding Strategy

NONE

As this is a resistance exercise training intervention, participants will be unable to be masked to their treatment condition.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Non-Exercise Control (CON)

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

Group Type ACTIVE_COMPARATOR

Non-Exercise Control Leg

Intervention Type OTHER

One leg will serve as a non-exercise control

Follicular Based Training (FOL)

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.

Group Type EXPERIMENTAL

Unilateral Resistance Exercise Leg

Intervention Type OTHER

One will perform unilateral resistance exercise

Luteal Based Training (LUT)

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.

Group Type EXPERIMENTAL

Unilateral Resistance Exercise Leg

Intervention Type OTHER

One will perform unilateral resistance exercise

Exercise Control (EX)

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.

Group Type EXPERIMENTAL

Unilateral Resistance Exercise Leg

Intervention Type OTHER

One will perform unilateral resistance exercise

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Unilateral Resistance Exercise Leg

One will perform unilateral resistance exercise

Intervention Type OTHER

Non-Exercise Control Leg

One leg will serve as a non-exercise control

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

McMaster University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Stuart Phillips

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Exercise Metabolism Research Laboratory, McMaster Univeristy

Hamilton, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

16355

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.