- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05936424
Menstrual Cycle Phase Based Training (MCPBT)
Investigating the Effects of Menstrual Cycle Phase Based Training on Muscle Strength and Hypertrophy
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,
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Hamilton, Ontario, Canada, L8S 4K1
- Exercise Metabolism Research Laboratory, McMaster Univeristy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Non-Exercise Control (CON)
This condition will serve as a non-exercise control and will not be performing resistance exercise training (RET)
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One leg will serve as a non-exercise control
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Experimental: 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.
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One will perform unilateral resistance exercise
|
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Experimental: 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.
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One will perform unilateral resistance exercise
|
|
Experimental: 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.
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One will perform unilateral resistance exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle Hypertrophy
Time Frame: 16 weeks
|
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
|
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Muscular Strength
Time Frame: 16 Weeks
|
The investigators will be measuring participant's muscle strength via one-repetition maximum testing using the unilateral leg press.
|
16 Weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 16355
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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