NCT07848438

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
59mo left

Started Aug 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress2%
Aug 2026Aug 2031

Study Start

First participant enrolled

August 20, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 23, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 30, 2026

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2031

Last Updated

September 30, 2026

Status Verified

September 1, 2026

Enrollment Period

5 years

First QC Date

September 23, 2026

Last Update Submit

September 23, 2026

Conditions

Keywords

MenopauseMenopausal Hormone TherapyHormone Replacement Therapy

Outcome Measures

Primary Outcomes (3)

  • Strength - Maximal Voluntary Contraction (MVC)

    Changes in MVC after 8 weeks resistance training. MVC is the greatest force generated during a brief isometric contraction.

    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.

    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

    One session before and then after 8 weeks of training

Study Arms (2)

Postmenopausal Hormone Therapy

EXPERIMENTAL

Postmenopausal females who are currently taking hormone replacement therapy

Other: HRT: High-Resistance Strength Training

Postmenopausal Female Controls

EXPERIMENTAL

Postmenopausal females who have no history of taking hormone replacement therapy

Other: Control: High-Resistance Strength Training

Interventions

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.

Postmenopausal Hormone Therapy

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.

Postmenopausal Female Controls

Eligibility Criteria

Age50 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Central Study Contacts

Sandra Hunter, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Francie Kraker Goodridge Collegiate Professor of Kinesiology and Professor of Kinesiology, School of Kinesiology

Study Record Dates

First Submitted

September 23, 2026

First Posted

September 30, 2026

Study Start

August 20, 2026

Primary Completion (Estimated)

August 1, 2031

Study Completion (Estimated)

August 1, 2031

Last Updated

September 30, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

No data will be shared

Locations