Women's HealthNCT04163380
Resistance Training and Sex Hormone Concentrations During the Menstrual Cycle
A study testing Resistance Training in people with Women's Health, run by Southern Illinois University Edwardsville at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Women's Health
- What is being tested?
- Resistance Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2019to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Eumenorrheic females
- Age 18-45 years old
- BMI of 18.5-34.99 kg/m2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Southern Illinois University Edwardsville
Edwardsville, Illinois, 62026
Maria Fernandez del Valle, PhD, 618-650-5905, marfern@siue.edu
Maria Fernandez del Valle, PhD
About this study
Official title: Acute Effects of Resistance Training on Sex Hormone Concentrations on Different Phases of the Menstrual Cycle
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.
- Conditions
- Women's Health
- Being tested
- Resistance Training
- Keywords
- Estrogen, Progesterone, Menstrual Cycle, Resistance Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance TrainingBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Early Follicular Phase (EFP) | Experimental | Not described Receives: Behavioral: Resistance Training |
| Late Follicular Phase (LFP) | Experimental | Not described Receives: Behavioral: Resistance Training |
| Early Luteal Phase (ELP) | Experimental | Not described Receives: Behavioral: Resistance Training |
| Late Luteal Phase (LLP) | Experimental | Not described Receives: Behavioral: Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in estrogen concentrations
Estrogen concentrations will be obtained from blood samples assessed using through ELISA kits
Measured: 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
Measured: through study completion, an average of 5 weeks
Secondary outcomes (8)
Lean body mass (kg)
Lean body mass (kg) will be assessed through Dual-energy X-ray Absorptiometry
Measured: At baseline: 1 assessment point
Fat mass (kg)
Fat mass (kg) will be assessed through Dual-energy X-ray Absorptiometry
Measured: At baseline: 1 assessment point
Relative body fat (%)
Relative body fat (%) will be assessed through Dual-energy X-ray Absorptiometry
Measured: At baseline: 1 assessment point
Skeletal muscle mass (kg)
Skeletal muscle mass (kg) will be estimated using Dual-energy X-ray Absorptiometry values
Measured: At baseline: 1 assessment point
Cardiorespiratory Fitness
Cardiorespiratory Fitness will be assessed with a cardiopulmonary exercise test using the Bruce protocol
Measured: At baseline: 1 assessment point
Strength in Bench Press
Maximal strength bench press will be assessed using one repetition maximum test
Measured: At baseline: 1 assessment point
Strength in Leg Press
Maximal strength in leg press will be assessed using one repetition maximum test
Measured: At baseline: 1 assessment point
Changes in diet
Diet will be assessed using the a 24h dietary recall
Measured: through study completion, an average of 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start1 Nov 2019
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women's HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southern Illinois University Edwardsville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04163380
- Sponsor's protocol ID
- 111B
- Status last verified
- May 2019
- First submitted
- 30 Oct 2019
- Last updated
- 18 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Resistance Training on Sex Hormone Concentrations on Different Phases of the Menstrual Cycle
- ClinicalTrials.gov ID
- NCT04163380
- Acronym / sponsor ID
- 111B
- Conditions
- Women's Health
- Keywords
- Estrogen, Progesterone, Menstrual Cycle, Resistance Training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Southern Illinois University EdwardsvilleUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 14 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Eumenorrheic females
- Age 18-45 years old
- BMI of 18.5-34.99 kg/m2
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance TrainingParticipants 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 | Behavioural | Early Follicular Phase (EFP), Early Luteal Phase (ELP), Late Follicular Phase (LFP), Late Luteal Phase (LLP) |
Primary outcome
Change in estrogen concentrations
Time frame: through study completion, an average of 5 weeks
Estrogen concentrations will be obtained from blood samples assessed using through ELISA kits
Change in progesterone concentrations
Time frame: through study completion, an average of 5 weeks
Progesterone concentrations will be obtained from blood samples assessed using through ELISA kits
8 secondary outcomes
Lean body mass (kg)
Time frame: At baseline: 1 assessment point
Fat mass (kg)
Time frame: At baseline: 1 assessment point
Relative body fat (%)
Time frame: At baseline: 1 assessment point
Skeletal muscle mass (kg)
Time frame: At baseline: 1 assessment point
Cardiorespiratory Fitness
Time frame: At baseline: 1 assessment point
Strength in Bench Press
Time frame: At baseline: 1 assessment point
Strength in Leg Press
Time frame: At baseline: 1 assessment point
Changes in diet
Time frame: through study completion, an average of 5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
- Individual participant dataSharing planned: No
Related trials for Women's Health
Not yet recruiting
Radiofrequency and Pelvic Floor Exercise for Primary Dysmenorrhea
Primary Dysmenorrhea
RecruitingObservational study
Lived Experiences of Women Diagnosed With HPV Infection
Human Papillomavirus Infection
Recruiting
Restoring Emotional Needs With Exogenous Ketones for Women With Postpartum Depression
Postpartum Depression (PPD)
RecruitingPhase 2/3
Focusing on the Menopausal Transition to Improve Mid-Life Women's Health
Menopause, Menopause Hot Flashes
Recruiting
Dance-Based Exercise Versus Clinical Pilates in Women With Overweight or Obesity
Overweight, Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Training in people with Women's Health, run by Southern Illinois University Edwardsville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Fernandez del Valle, PhD (6186505905, marfern@siue.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in estrogen concentrations (time frame: through study completion, an average of 5 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2020.