- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04163380
Resistance Training and Sex Hormone Concentrations During the Menstrual Cycle
February 15, 2020 updated by: Southern Illinois University Edwardsville
Acute Effects of Resistance Training on Sex Hormone Concentrations on Different Phases of the Menstrual Cycle
Although there are numerous studies showing effects of aerobic training on sex hormone concentrations, research analyzing the fluctuation of sex hormones in response to resistance training (RT) is lacking.
The objective of this project is to analyze estradiol (E2) and progesterone (P4) responses to an acute resistance training session throughout different phases of the menstrual cycle.
This proposed research has strong implications for exercise prescription and for women in general, but more importantly will allow exercise physiologists, coaches, personal trainers, or nutritionists optimize exercise programming around women's menstrual cycle.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Edwardsville, Illinois, United States, 62026
- Recruiting
- Southern Illinois University Edwardsville
-
Contact:
- Maria Fernandez del Valle, PhD
- Phone Number: 618-650-5905
- Email: marfern@siue.edu
-
Principal Investigator:
- Maria Fernandez del Valle, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Eumenorrheic females
- Age 18-45 years old
- BMI of 18.5-34.99 kg/m2
Exclusion Criteria:
- Practice exercise more than 2 days/week in the last 3 months.
- Cardiovascular, metabolic, pulmonary or muscular-skeletal condition
- Taking medications that affect metabolism (e.g. oral contraceptives)
- Irregular menstrual cycles
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Early Follicular Phase (EFP)
|
Participants will exercise at the mid-point of each menstrual cycle phase (EFP- day 4, LFP- day 11, ELP- day 18 and LLP- day 25 for a 28 day menstrual cycle).
Training will consist of a warm up.
Intensity will be set at 70% of 1RM, and the circuit training will include 7 strength exercises: leg press, rows, back squat, weighted crunches, deadlifts, bench press, and weighted squat jumps.
The participant will perform 3 sets f 10 repetitions with 30 seconds of rest
|
|
Experimental: Late Follicular Phase (LFP)
|
Participants will exercise at the mid-point of each menstrual cycle phase (EFP- day 4, LFP- day 11, ELP- day 18 and LLP- day 25 for a 28 day menstrual cycle).
Training will consist of a warm up.
Intensity will be set at 70% of 1RM, and the circuit training will include 7 strength exercises: leg press, rows, back squat, weighted crunches, deadlifts, bench press, and weighted squat jumps.
The participant will perform 3 sets f 10 repetitions with 30 seconds of rest
|
|
Experimental: Early Luteal Phase (ELP)
|
Participants will exercise at the mid-point of each menstrual cycle phase (EFP- day 4, LFP- day 11, ELP- day 18 and LLP- day 25 for a 28 day menstrual cycle).
Training will consist of a warm up.
Intensity will be set at 70% of 1RM, and the circuit training will include 7 strength exercises: leg press, rows, back squat, weighted crunches, deadlifts, bench press, and weighted squat jumps.
The participant will perform 3 sets f 10 repetitions with 30 seconds of rest
|
|
Experimental: Late Luteal Phase (LLP)
|
Participants will exercise at the mid-point of each menstrual cycle phase (EFP- day 4, LFP- day 11, ELP- day 18 and LLP- day 25 for a 28 day menstrual cycle).
Training will consist of a warm up.
Intensity will be set at 70% of 1RM, and the circuit training will include 7 strength exercises: leg press, rows, back squat, weighted crunches, deadlifts, bench press, and weighted squat jumps.
The participant will perform 3 sets f 10 repetitions with 30 seconds of rest
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in estrogen concentrations
Time Frame: through study completion, an average of 5 weeks
|
Estrogen concentrations will be obtained from blood samples assessed using through ELISA kits
|
through study completion, an average of 5 weeks
|
|
Change in progesterone concentrations
Time Frame: through study completion, an average of 5 weeks
|
Progesterone concentrations will be obtained from blood samples assessed using through ELISA kits
|
through study completion, an average of 5 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lean body mass (kg)
Time Frame: At baseline: 1 assessment point
|
Lean body mass (kg) will be assessed through Dual-energy X-ray Absorptiometry
|
At baseline: 1 assessment point
|
|
Fat mass (kg)
Time Frame: At baseline: 1 assessment point
|
Fat mass (kg) will be assessed through Dual-energy X-ray Absorptiometry
|
At baseline: 1 assessment point
|
|
Relative body fat (%)
Time Frame: At baseline: 1 assessment point
|
Relative body fat (%) will be assessed through Dual-energy X-ray Absorptiometry
|
At baseline: 1 assessment point
|
|
Skeletal muscle mass (kg)
Time Frame: At baseline: 1 assessment point
|
Skeletal muscle mass (kg) will be estimated using Dual-energy X-ray Absorptiometry values
|
At baseline: 1 assessment point
|
|
Cardiorespiratory Fitness
Time Frame: At baseline: 1 assessment point
|
Cardiorespiratory Fitness will be assessed with a cardiopulmonary exercise test using the Bruce protocol
|
At baseline: 1 assessment point
|
|
Strength in Bench Press
Time Frame: At baseline: 1 assessment point
|
Maximal strength bench press will be assessed using one repetition maximum test
|
At baseline: 1 assessment point
|
|
Strength in Leg Press
Time Frame: At baseline: 1 assessment point
|
Maximal strength in leg press will be assessed using one repetition maximum test
|
At baseline: 1 assessment point
|
|
Changes in diet
Time Frame: through study completion, an average of 5 weeks
|
Diet will be assessed using the a 24h dietary recall
|
through study completion, an average of 5 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2019
Primary Completion (Anticipated)
December 1, 2021
Study Completion (Anticipated)
December 1, 2021
Study Registration Dates
First Submitted
October 30, 2019
First Submitted That Met QC Criteria
November 13, 2019
First Posted (Actual)
November 14, 2019
Study Record Updates
Last Update Posted (Actual)
February 18, 2020
Last Update Submitted That Met QC Criteria
February 15, 2020
Last Verified
May 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 111B
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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