MenopauseNCT07848438
Sex Hormones and Aging
A study testing HRT: High-Resistance Strength Training in people with Menopause and Menopausal Hormone Therapy, run by University of Michigan at 1 site in United States.
Trial summary
This study investigates the influence of sex hormones and exercise on age-related neuromuscular decline in females. Specifically, the research aims to evaluate how hormonal variations impact both age-associated neuromuscular decline and the subsequent adaptations to exercise and resistance training. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Menopausal Hormone Therapy, Aging
- What is being tested?
- HRT: High-Resistance Strength Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2026to Aug 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Females who are pregnant or likely to be pregnant. Female subjects of childbearing age will be asked of the possibility of pregnancy and will be excluded from the study if they are pregnant or become pregnant during the study.
- Females who are not currently taking HT but have taken HT in the past 5 years.
- Severe obesity (body mass index, BMI, > 45 kg/m2): this will be calculated from measured height and weight
- Untreated hypothyroidism
- Uncontrolled blood pressure (>160/100 mmHg at rest)
- Epilepsy or increased risk of seizures
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- Metal implants in the body, excluding the mouth
- Head injury in the past 6 months
- People who are taking any of the following medications: Medications that affect cortical excitability, Nonsteroidal anti-inflammatory drug (NSAID) use in the past 24 hours or chronic use of NSAIDs, Beta blockers or any other heart rate stabilizing medications, Any neurological, cardiovascular or musculoskeletal disease that precludes exercise testing
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Sandra Hunter, PhD, (734) 647-6019, sandrahu@umich.edu
Sarah Lessila, MS, slessila@umich.edu
About this study
Official title: Hormone-Related Mechanisms of Neuromuscular Aging and Exercise Adaptation
This study investigates the influence of sex hormones and exercise on age-related neuromuscular decline in females. Specifically, the research aims to evaluate how hormonal variations impact both age-associated neuromuscular decline and the subsequent adaptations to exercise and resistance training.
Age-related declines in neuromuscular function are especially pronounced in females, potentially due to the sharp drop in estradiol after menopause. This project will compare postmenopausal females who have not taken hormonal therapy (HT) to age-matched females taking HT.
Read the detailed description
The primary objective of the research is to and evaluate how hormonal status influences the neural and muscular drivers of strength and fatigue, which we have divided into two central Aims. Aim 1 will assess baseline differences in neuromuscular function between HT females and non-HT females. In Aim 2, participants will complete an 8-week high-resistance training program to evaluate the effects of sex and HT on neuromuscular adaptations.
At the University of Michigan, populations recruited will include:
- 60 healthy older females who have not used any form of HT
- 60 healthy older females who have been prescribed HT by their physician
- Conditions
- Menopause, Menopausal Hormone Therapy, Aging
- Being tested
- HRT: High-Resistance Strength Training, Control: High-Resistance Strength Training
- Keywords
- Menopause, Menopausal Hormone Therapy, Hormone Replacement Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRT: High-Resistance Strength TrainingOther
Each participant will attend 2 sessions per week for 8 weeks. A training session will start with a 10-minute full body dynamic warm-up (e.g., bodyweight movements and mobility exercises). The participant will then perform bilateral lower body high-resistance strength training exercises (leg extension and leg press) for 4 sets of 8-10 repetitions.
Control: High-Resistance Strength TrainingOther
Each participant will attend 2 sessions per week for 8 weeks. A training session will start with a 10-minute full body dynamic warm-up (e.g., bodyweight movements and mobility exercises). The participant will then perform bilateral lower body high-resistance strength training exercises (leg extension and leg press) for 4 sets of 8-10 repetitions.
| Study group | Role | What they receive |
|---|---|---|
| Postmenopausal Hormone Therapy | Experimental | Postmenopausal females who are currently taking hormone replacement therapy Receives: Other: HRT: High-Resistance Strength Training |
| Postmenopausal Female Controls | Experimental | Postmenopausal females who have no history of taking hormone replacement therapy Receives: Other: Control: High-Resistance Strength Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strength - Maximal Voluntary Contraction (MVC)
Changes in MVC after 8 weeks resistance training. MVC is the greatest force generated during a brief isometric contraction.
Measured: One session before and then after 8 weeks of training
Fatigability - Reduction in Power
Reduction in limb power and maximal force in response to a dynamic fatiguing contraction.
Measured: One session before and then after 8 weeks of training
Strength - 1 Repetition Maximum
Reduction in limb power and maximal force in response to a dynamic fatiguing contraction
Measured: One session before and then after 8 weeks of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start20 Aug 2026
- Primary completionAug 2031 (estimated)
- Study completionAug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Each participant will attend 2 sessions per week for 8 weeks. A training session will start with a 10-minute full body dynamic warm-up (e.g., bodyweight movements and mobility exercises). The participant will then perform bilateral lower body high-resistance strength training exercises (leg extension and leg press) for 4 sets of 8-10 repetitions.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Hunter, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07848438
- Sponsor's protocol ID
- HUM00289422
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hormone-Related Mechanisms of Neuromuscular Aging and Exercise Adaptation
- ClinicalTrials.gov ID
- NCT07848438
- Acronym / sponsor ID
- HUM00289422
- Conditions
- Menopause, Menopausal Hormone Therapy, Aging
- Keywords
- Menopause, Menopausal Hormone Therapy, Hormone Replacement Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 20 Aug 2026 (actual)
- Primary completion
- Aug 2031 (estimated)
- Study completion
- Aug 2031 (estimated)
- First posted
- 30 Sep 2026 (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.
This study investigates the influence of sex hormones and exercise on age-related neuromuscular decline in females. Specifically, the research aims to evaluate how hormonal variations impact both age-associated neuromuscular decline and the subsequent adaptations to exercise and resistance training.
Age-related declines in neuromuscular function are especially pronounced in females, potentially due to the sharp drop in estradiol after menopause. This project will compare postmenopausal females who have not taken hormonal therapy (HT) to age-matched females taking HT.
Detailed description
The primary objective of the research is to and evaluate how hormonal status influences the neural and muscular drivers of strength and fatigue, which we have divided into two central Aims. Aim 1 will assess baseline differences in neuromuscular function between HT females and non-HT females. In Aim 2, participants will complete an 8-week high-resistance training program to evaluate the effects of sex and HT on neuromuscular adaptations.
At the University of Michigan, populations recruited will include:
- 60 healthy older females who have not used any form of HT
- 60 healthy older females who have been prescribed HT by their physician
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each participant will attend 2 sessions per week for 8 weeks. A training session will start with a 10-minute full body dynamic warm-up (e.g., bodyweight movements and mobility exercises). The participant will then perform bilateral lower body high-resistance strength training exercises (leg extension and leg press) for 4 sets of 8-10 repetitions.
| Arm | Type | Receives |
|---|---|---|
| Postmenopausal Hormone Therapy | Experimental | Other: HRT: High-Resistance Strength TrainingPostmenopausal females who are currently taking hormone replacement therapy |
| Postmenopausal Female Controls | Experimental | Other: Control: High-Resistance Strength TrainingPostmenopausal females who have no history of taking hormone replacement therapy |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- Females who are pregnant or likely to be pregnant. Female subjects of childbearing age will be asked of the possibility of pregnancy and will be excluded from the study if they are pregnant or become pregnant during the study.
- Females who are not currently taking HT but have taken HT in the past 5 years.
- Severe obesity (body mass index, BMI, > 45 kg/m2): this will be calculated from measured height and weight
- Untreated hypothyroidism
- Uncontrolled blood pressure (>160/100 mmHg at rest)
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 |
|---|---|---|
| HRT: High-Resistance Strength TrainingEach participant will attend 2 sessions per week for 8 weeks. A training session will start with a 10-minute full body dynamic warm-up (e.g., bodyweight movements and mobility exercises). The participant will then perform bilateral lower body high-resistance strength training exercises (leg extension and leg press) for 4 sets of 8-10 repetitions. | Other | Postmenopausal Hormone Therapy |
| Control: High-Resistance Strength TrainingEach participant will attend 2 sessions per week for 8 weeks. A training session will start with a 10-minute full body dynamic warm-up (e.g., bodyweight movements and mobility exercises). The participant will then perform bilateral lower body high-resistance strength training exercises (leg extension and leg press) for 4 sets of 8-10 repetitions. | Other | Postmenopausal Female Controls |
Primary outcome
Strength - Maximal Voluntary Contraction (MVC)
Time frame: One session before and then after 8 weeks of training
Changes in MVC after 8 weeks resistance training. MVC is the greatest force generated during a brief isometric contraction.
Fatigability - Reduction in Power
Time frame: One session before and then after 8 weeks of training
Reduction in limb power and maximal force in response to a dynamic fatiguing contraction.
Strength - 1 Repetition Maximum
Time frame: One session before and then after 8 weeks of training
Reduction in limb power and maximal force in response to a dynamic fatiguing contraction
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No. No data will be shared
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HRT: High-Resistance Strength Training in people with Menopause and Menopausal Hormone Therapy, run by University of Michigan 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 0 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 30 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sandra Hunter, PhD ((734) 647-9819, sandrahu@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strength - Maximal Voluntary Contraction (MVC) (time frame: One session before and then after 8 weeks of training). The study lists 3 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 30 Sep 2026.