Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 54 of 264 for:    Estrogen Resistance

Effects of Resistance Training in Body Composition and Body Image Perception of Women Throughout the Menstrual Cycle

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04038463
Recruitment Status : Not yet recruiting
First Posted : July 30, 2019
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Southern Illinois University Edwardsville

Brief 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.

Condition or disease Intervention/treatment Phase
Body Image Disturbance Behavioral: EFP Behavioral: LFP Behavioral: ELP Behavioral: LLP Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Resistance Training in Body Composition and Body Image Perception of Women Throughout the Menstrual Cycle
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menstruation

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).
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).

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).
Behavioral: 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).

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).
Behavioral: 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).

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).
Behavioral: 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).




Primary Outcome Measures :
  1. Body Image Perception through questionnaire [ Time Frame: Through study completion: an average of 1 month ]
    Participants will be distributed the Multidimensional Body-Self Relations Questionnaire-Appearance Scale (MBSRQ-AS) to measure their body image perceptions.

  2. Body Image Perception through drawing scale [ Time Frame: Through study completion: an average of 1 month ]
    Participants will be distributed the Contour Drawing Rating Scale to measure their body image perception.

  3. Barriers to Weight Control [ Time Frame: Through study completion: an average of 1 month ]
    Participants will be distributed the Survey of Barriers to Weight Control to measure their body image perception.

  4. Fat Mass in Kilograms [ Time Frame: Through study completion: an average of 1 month ]
    We will measure fat mass using the Dual-Energy Xray Absorptiometry (DXA)

  5. Lean Body Mass in Kilograms [ Time Frame: Through study completion: an average of 1 month ]
    We will measure lean body mass using the Dual-Energy Xray Absorptiometry (DXA)

  6. Relative Body Fat [ Time Frame: Through study completion: an average of 1 month ]
    We will measure relative body fat (percentage) using the Dual-Energy Xray Absorptiometry (DXA)


Secondary Outcome Measures :
  1. Bench Press One Repetition Maximum [ Time Frame: At baseline: 1 assessment point prior randomization ]
    Participants muscular strength will be assessed by a one-repetition (1RM) on bench press

  2. Leg Press One Repetition Maximum [ Time Frame: At baseline: 1 assessment point prior randomization ]
    Participants lower body muscular strength will be assessed by a one-repetition (1RM) on leg press

  3. Dietary habits [ Time Frame: Before each exercise session: 1 assessment point on each menstrual cycle phase ]
    The participants diet will be recorded using the ASA-24h recall

  4. Estrogen (Estradiol) levels [ Time Frame: Before each exercise session: 1 assessment point on each menstrual cycle phase ]
    Blood will be drawn from the participants for assessment of the estrogen hormone

  5. Progesterone levels [ Time Frame: Before each exercise session: 1 assessment point on each menstrual cycle phase ]
    Blood will be drawn from the participants for assessment of the progesterone hormone



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Participants must be female and have normal menstrual cycles.
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04038463


Contacts
Layout table for location contacts
Contact: Maria Fernandez del Valle, PhD 6186505905 marfern@siue.edu
Contact: Maria Fernandez del Valle, PhD 6186505905 merfern@siue.edu

Locations
Layout table for location information
United States, Illinois
Southern Illinois University Edwardsville Not yet recruiting
Edwardsville, Illinois, United States, 62026
Sponsors and Collaborators
Southern Illinois University Edwardsville
Investigators
Layout table for investigator information
Principal Investigator: Maria Fernandez del Valle, PhD Southern Illinois University Edwardsville

Layout table for additonal information
Responsible Party: Southern Illinois University Edwardsville
ClinicalTrials.gov Identifier: NCT04038463     History of Changes
Other Study ID Numbers: 160
First Posted: July 30, 2019    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Southern Illinois University Edwardsville:
Menstrual Cycle
Resistance Training
Body Composition
Intervention
Exercise