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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04038463
Other study ID # 160
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date September 1, 2019
Est. completion date March 16, 2020

Study information

Verified date July 2019
Source Southern Illinois University Edwardsville
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 6
Est. completion date March 16, 2020
Est. primary completion date March 16, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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).
LFP
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).
ELP
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).
LLP
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).

Locations

Country Name City State
United States Southern Illinois University Edwardsville Edwardsville Illinois

Sponsors (1)

Lead Sponsor Collaborator
Southern Illinois University Edwardsville

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Body Image Perception through questionnaire Participants will be distributed the Multidimensional Body-Self Relations Questionnaire-Appearance Scale (MBSRQ-AS) to measure their body image perceptions. Through study completion: an average of 1 month
Primary Body Image Perception through drawing scale Participants will be distributed the Contour Drawing Rating Scale to measure their body image perception. Through study completion: an average of 1 month
Primary Barriers to Weight Control Participants will be distributed the Survey of Barriers to Weight Control to measure their body image perception. Through study completion: an average of 1 month
Primary Fat Mass in Kilograms We will measure fat mass using the Dual-Energy Xray Absorptiometry (DXA) Through study completion: an average of 1 month
Primary Lean Body Mass in Kilograms We will measure lean body mass using the Dual-Energy Xray Absorptiometry (DXA) Through study completion: an average of 1 month
Primary Relative Body Fat We will measure relative body fat (percentage) using the Dual-Energy Xray Absorptiometry (DXA) Through study completion: an average of 1 month
Secondary Bench Press One Repetition Maximum Participants muscular strength will be assessed by a one-repetition (1RM) on bench press At baseline: 1 assessment point prior randomization
Secondary Leg Press One Repetition Maximum Participants lower body muscular strength will be assessed by a one-repetition (1RM) on leg press At baseline: 1 assessment point prior randomization
Secondary Dietary habits The participants diet will be recorded using the ASA-24h recall Before each exercise session: 1 assessment point on each menstrual cycle phase
Secondary Estrogen (Estradiol) levels Blood will be drawn from the participants for assessment of the estrogen hormone Before each exercise session: 1 assessment point on each menstrual cycle phase
Secondary Progesterone levels Blood will be drawn from the participants for assessment of the progesterone hormone Before each exercise session: 1 assessment point on each menstrual cycle phase
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