NCT07022340

Brief Summary

Women's blood vessel health gets worse after menopause, or "the change of life". Some women exercise less during menopause. Exercise can improve blood vessel health. The investigators want to know if resistance exercise, like lifting weights, can improve blood vessel health in women who are just starting menopause. The investigators also want to know if lifting weights can improve mood, sleep, and quality of life in women going through menopause. The investigators will have two groups of women for this study. One group will lift weights (do resistance exercise) twice per week, and the other group will get emails with information about menopause. The investigators will measure blood vessel health, sleep, mood, and menopause symptoms at the start and the end of this study and compare women who did and did not exercise.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 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

First Submitted

Initial submission to the registry

June 4, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

June 6, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 15, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

July 11, 2025

Status Verified

July 1, 2025

Enrollment Period

9 months

First QC Date

June 4, 2025

Last Update Submit

July 8, 2025

Conditions

Keywords

menopauseperimenopausevascular functionarterial stiffnessendothelial functionresistance exercise trainingstrength trainingmoodsleepquality of lifecardiovascular diseaseestrogen deficiencyexercise

Outcome Measures

Primary Outcomes (2)

  • Vascular function

    Arterial stiffness and wave reflection will be measured at baseline and following the 16-week study period using cuff-based waveform acquisition and applanation tonometry.

    At baseline and the end of the 16 week study period

  • Endothelial Function

    Endothelial function will be measured at baseline and following the 16-week study period using brachial artery flow-mediated dilation measured with vascular ultrasound.

    At baseline and the end of the 16 week study period

Secondary Outcomes (3)

  • Mood scores

    At baseline and the end of the 16 week study period

  • Sleep quality

    At baseline and the end of the 16 week study period

  • Menopause-specific quality of life

    At baseline and the end of the 16 week study period

Study Arms (2)

Resistance Training Intervention

EXPERIMENTAL

Participants randomized to resistance training will complete two sessions/week for 16 weeks.

Behavioral: Resistance Training Intervention

Health Education Intervention

NO INTERVENTION

Participants randomized to the health education control group will receive weekly emails with general menopause information. They will be instructed to maintain current lifestyle habits, including exercise habits while enrolled in this study. They will be provided with a personalized resistance training program, equipment orientation/training session, and a counseling phone call with an exercise physiologist following study completion, or they can re-enroll in the resistance training intervention after completing the control portion of the study.

Interventions

Participants will complete a brief aerobic warm-up and dynamic stretching prior to each strength training session. Participants will complete 9 exercises for all major muscle groups. Strength testing at the baseline study visit will be used to determine initial load. Participants will complete 1 set of moderate-intensity loads (\~50% maximum and \~12 repetitions) in week 1, 2 sets in week 2, and 3 sets in week 3. By week 4, participants will be completing 3 sets at 60% of maximum. Weight loads will be progressively increased so volitional fatigue is reached by 8-12 repetitions/set.

Resistance Training Intervention

Eligibility Criteria

Age40 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
* Are between 40-60 years old * Have had menstrual irregularities in the last 12 months * Do not currently complete more than two 30-min sessions of structured exercise per week and do not do any resistance training exercise; * Are not currently pregnant * Do not smoke or vape nicotine or marijuana * Have not had an oophorectomy, hysterectomy, or surgical menopause * Are not currently taking hormone replacement therapy * Have not taken hormone replacement therapy in the last 6 months * Are not taking steroidal medication or medication to treat diabetes, cholesterol, or high blood pressure * Are able to exercise - your doctor has not told you that you cannot exercise * Can attend a morning study visit at the University of Michigan's School of Kinesiology Building * Are willing to avoid food 2 hours prior to the morning study visit * Are willing to avoid strenuous exercise, caffeine, and alcohol, 8 hours prior to the morning study visit * Are willing to participate in an exercise training program or health education program for 16 weeks

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Michigan School of Kinesiology

Ann Arbor, Michigan, 48109, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Cardiovascular DiseasesMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Marnie K. McLean, M.S.

    University of Michigan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marnie K. McLean, M.S.

CONTACT

Abbi D. Lane, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 4, 2025

First Posted

June 15, 2025

Study Start

June 6, 2025

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

July 11, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

Only deidentified data may be shared. No individual's name or identifiers will be published or shared. Requests for limited datasets will be considered.

Locations