NCT04163380

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

October 30, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 14, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

February 18, 2020

Status Verified

May 1, 2019

Enrollment Period

2.1 years

First QC Date

October 30, 2019

Last Update Submit

February 15, 2020

Conditions

Keywords

EstrogenProgesteroneMenstrual CycleResistance Training

Outcome Measures

Primary Outcomes (2)

  • Change in estrogen concentrations

    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

    Progesterone concentrations will be obtained from blood samples assessed using through ELISA kits

    through study completion, an average of 5 weeks

Secondary Outcomes (8)

  • Lean body mass (kg)

    At baseline: 1 assessment point

  • Fat mass (kg)

    At baseline: 1 assessment point

  • Relative body fat (%)

    At baseline: 1 assessment point

  • Skeletal muscle mass (kg)

    At baseline: 1 assessment point

  • Cardiorespiratory Fitness

    At baseline: 1 assessment point

  • +3 more secondary outcomes

Study Arms (4)

Early Follicular Phase (EFP)

EXPERIMENTAL
Behavioral: Resistance Training

Late Follicular Phase (LFP)

EXPERIMENTAL
Behavioral: Resistance Training

Early Luteal Phase (ELP)

EXPERIMENTAL
Behavioral: Resistance Training

Late Luteal Phase (LLP)

EXPERIMENTAL
Behavioral: Resistance Training

Interventions

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

Early Follicular Phase (EFP)Early Luteal Phase (ELP)Late Follicular Phase (LFP)Late Luteal Phase (LLP)

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemales
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Eumenorrheic females
  • Age 18-45 years old
  • BMI of 18.5-34.99 kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southern Illinois University Edwardsville

Edwardsville, Illinois, 62026, United States

RECRUITING

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Maria Fernandez del Valle, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Participants will be blocked (four participants by block) and then randomized to start in one of the four menstrual cycle phases (EFP, LFP, ELP, or LLP). Their will be complete once they have gone through the four phases.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2019

First Posted

November 14, 2019

Study Start

November 1, 2019

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

February 18, 2020

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations