- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04038463
Effects of Resistance Training in Body Composition and Body Image Perception of Women Throughout the Menstrual Cycle
September 27, 2021 updated by: Southern Illinois University Edwardsville
The objective of this research study is two-fold, 1) to determine if body composition and body image perception are affected through the different phases of the menstrual cycle, and 2) if an acute session of resistance training can have different effects depending on the menstrual cycle phase.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
The purpose of the research is to establish whether body composition and body image perception are affected throughout the different phases of the menstrual cycle and if the perception can be modified through resistance training.
To the best of our knowledge, only one study has analyzed the effects of the menstrual cycle on body image perception.
However, research analyzing the effects of the menstrual cycle on both body image perception and, body composition is lacking.
Furthermore, research in the effects of resistance training on menstrual cycle-related changes on both perceived and measured body composition are inexistent.
Findings from this study have the potential to increase the knowledge about resistance training's effects in modulating body image perception throughout the menstrual cycle.
Further understanding of these responses may set the groundwork to develop exercise intervention programs to reduce the risk of developing more serious mental conditions linked to unhealthy body image perception.
Study Type
Interventional
Enrollment (Actual)
6
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
-
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Illinois
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Edwardsville, Illinois, United States, 62026
- Southern Illinois University Edwardsville
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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
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Female
- Sedentary or Active
- 18.5-34.9 kg/m2 BMI
- Normal menstrual cycle defined as 28 to 30 days and a duration of 3 to 7 days
- Age range is 18-45 years old
- The inclusion of other participants may alter the results as an increase in body fat has been linked to known changes in different hormonal levels and those changes might influence substrate utilization
- Changes in the hormonal status of pre-menopausal women may appear without symptoms
- Younger females also display variations in their hormones since they are going through the process of development
Exclusion Criteria:
- Previous physiological and mental health history
- Pregnant females
- Males
- Irregular menstrual cycle, menstrual dysfunction or unusual sex hormone levels
- Musculoskeletal injuries
- Contraceptives, a medication that alters hormonal or cardio-respiratory responses
- Pre-menopausal symptoms
- On moderate to high-intensity exercise regime more than 2 days/week
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)
The group will engage in the Resistance Training intervention on the fourth day of their menstrual cycle, which will correlate with the middle of the early follicular phase (EFP).
|
This intervention will take place on day 4 of the participants' menstrual cycle.
This will correspond to the mid-point of the early follicular phase (EFP).
|
Experimental: Late Follicular Phase (LFP)
The group will engage in the Resistance Training intervention on the eleventh day of their menstrual cycle, which will correlate with the middle of the late follicular phase (LFP).
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The intervention will take place on day 8 of the participants' menstrual cycle.
This will correspond to the mid-point of the late follicular phase (LFP).
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Experimental: Early Luteal Phase (ELP)
The group will engage in the Resistance Training intervention on the eighteenth of their menstrual cycle, which will correlate with the middle of the early luteal phase (ELP).
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The intervention will take place on day 18 of the participants' menstrual cycle.
This will correspond to the mid-point of the early luteal phase (ELP).
|
Experimental: Late Luteal Phase (LLP)
The group will engage in the Resistance Training intervention on the twenty-fifth day of their menstrual cycle, which will correlate with the middle of the late luteal phase (LLP).
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The intervention will take place on day 25 of the participants' menstrual cycle.
This will correspond to the mid-point of the late luteal phase (LLP).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body Image Perception through questionnaire
Time Frame: Through study completion: an average of 1 month
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Participants will be distributed the Multidimensional Body-Self Relations Questionnaire-Appearance Scale (MBSRQ-AS) to measure their body image perceptions.
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Through study completion: an average of 1 month
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Body Image Perception through drawing scale
Time Frame: Through study completion: an average of 1 month
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Participants will be distributed the Contour Drawing Rating Scale to measure their body image perception.
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Through study completion: an average of 1 month
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Barriers to Weight Control
Time Frame: Through study completion: an average of 1 month
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Participants will be distributed the Survey of Barriers to Weight Control to measure their body image perception.
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Through study completion: an average of 1 month
|
Fat Mass in Kilograms
Time Frame: Through study completion: an average of 1 month
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We will measure fat mass using the Dual-Energy Xray Absorptiometry (DXA)
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Through study completion: an average of 1 month
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Lean Body Mass in Kilograms
Time Frame: Through study completion: an average of 1 month
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We will measure lean body mass using the Dual-Energy Xray Absorptiometry (DXA)
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Through study completion: an average of 1 month
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Relative Body Fat
Time Frame: Through study completion: an average of 1 month
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We will measure relative body fat (percentage) using the Dual-Energy Xray Absorptiometry (DXA)
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Through study completion: an average of 1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bench Press One Repetition Maximum
Time Frame: At baseline: 1 assessment point prior randomization
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Participants muscular strength will be assessed by a one-repetition (1RM) on bench press
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At baseline: 1 assessment point prior randomization
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Leg Press One Repetition Maximum
Time Frame: At baseline: 1 assessment point prior randomization
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Participants lower body muscular strength will be assessed by a one-repetition (1RM) on leg press
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At baseline: 1 assessment point prior randomization
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Dietary habits
Time Frame: Before each exercise session: 1 assessment point on each menstrual cycle phase
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The participants diet will be recorded using the ASA-24h recall
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Before each exercise session: 1 assessment point on each menstrual cycle phase
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Estrogen (Estradiol) levels
Time Frame: Before each exercise session: 1 assessment point on each menstrual cycle phase
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Blood will be drawn from the participants for assessment of the estrogen hormone
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Before each exercise session: 1 assessment point on each menstrual cycle phase
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Progesterone levels
Time Frame: Before each exercise session: 1 assessment point on each menstrual cycle phase
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Blood will be drawn from the participants for assessment of the progesterone hormone
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Before each exercise session: 1 assessment point on each menstrual cycle phase
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Maria Fernandez del Valle, PhD, 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)
September 1, 2019
Primary Completion (Actual)
March 16, 2020
Study Completion (Actual)
March 16, 2020
Study Registration Dates
First Submitted
May 21, 2019
First Submitted That Met QC Criteria
July 29, 2019
First Posted (Actual)
July 30, 2019
Study Record Updates
Last Update Posted (Actual)
October 4, 2021
Last Update Submitted That Met QC Criteria
September 27, 2021
Last Verified
July 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 160
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
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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