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

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Maria Fernandez del Valle, PhD
  • Phone Number: 6186505905
  • Email: marfern@siue.edu

Study Locations

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Early Follicular Phase (EFP)
Behavioral: Resistance Training
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)
Behavioral: Resistance Training
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)
Behavioral: Resistance Training
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)
Behavioral: Resistance Training
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Southern Illinois University Edwardsville

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 30, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 14, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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