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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04163380
Other study ID # 111B
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 1, 2019
Est. completion date December 2021

Study information

Verified date May 2019
Source Southern Illinois University Edwardsville
Contact Maria Fernandez del Valle, PhD
Phone 6186505905
Email marfern@siue.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 25
Est. completion date December 2021
Est. primary completion date December 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Eumenorrheic females

- Age 18-45 years old

- BMI of 18.5-34.99 kg/m2

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Resistance Training
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

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 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
Primary 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 Lean body mass (kg) Lean body mass (kg) will be assessed through Dual-energy X-ray Absorptiometry At baseline: 1 assessment point
Secondary Fat mass (kg) Fat mass (kg) will be assessed through Dual-energy X-ray Absorptiometry At baseline: 1 assessment point
Secondary Relative body fat (%) Relative body fat (%) will be assessed through Dual-energy X-ray Absorptiometry At baseline: 1 assessment point
Secondary Skeletal muscle mass (kg) Skeletal muscle mass (kg) will be estimated using Dual-energy X-ray Absorptiometry values At baseline: 1 assessment point
Secondary Cardiorespiratory Fitness Cardiorespiratory Fitness will be assessed with a cardiopulmonary exercise test using the Bruce protocol At baseline: 1 assessment point
Secondary Strength in Bench Press Maximal strength bench press will be assessed using one repetition maximum test At baseline: 1 assessment point
Secondary Strength in Leg Press Maximal strength in leg press will be assessed using one repetition maximum test At baseline: 1 assessment point
Secondary Changes in diet Diet will be assessed using the a 24h dietary recall through study completion, an average of 5 weeks
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