NCT04038463

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 30, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2020

Completed
Last Updated

October 4, 2021

Status Verified

July 1, 2019

Enrollment Period

7 months

First QC Date

May 21, 2019

Last Update Submit

September 27, 2021

Conditions

Keywords

Menstrual CycleResistance TrainingBody CompositionInterventionExercise

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • Fat Mass in Kilograms

    We will measure fat mass using the Dual-Energy Xray Absorptiometry (DXA)

    Through study completion: an average of 1 month

  • 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

  • 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 Outcomes (5)

  • Bench Press One Repetition Maximum

    At baseline: 1 assessment point prior randomization

  • Leg Press One Repetition Maximum

    At baseline: 1 assessment point prior randomization

  • Dietary habits

    Before each exercise session: 1 assessment point on each menstrual cycle phase

  • Estrogen (Estradiol) levels

    Before each exercise session: 1 assessment point on each menstrual cycle phase

  • Progesterone levels

    Before each exercise session: 1 assessment point on each menstrual cycle phase

Study Arms (4)

Early Follicular Phase (EFP)

EXPERIMENTAL

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

Late Follicular Phase (LFP)

EXPERIMENTAL

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

Early Luteal Phase (ELP)

EXPERIMENTAL

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

Late Luteal Phase (LLP)

EXPERIMENTAL

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

Interventions

EFPBEHAVIORAL

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).

Early Follicular Phase (EFP)
LFPBEHAVIORAL

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).

Late Follicular Phase (LFP)
ELPBEHAVIORAL

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).

Early Luteal Phase (ELP)
LLPBEHAVIORAL

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).

Late Luteal Phase (LLP)

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsParticipants must be female and have normal menstrual cycles.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female
  • Sedentary or Active
  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southern Illinois University Edwardsville

Edwardsville, Illinois, 62026, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Maria Fernandez del Valle, PhD

    Southern Illinois University Edwardsville

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2019

First Posted

July 30, 2019

Study Start

September 1, 2019

Primary Completion

March 16, 2020

Study Completion

March 16, 2020

Last Updated

October 4, 2021

Record last verified: 2019-07

Locations