Resistance Training for Perimenopause

(HeART Trial)

Overseen By Abbi D. Lane, Ph.D.

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Michigan

Must not be taking: Hormone therapy, Steroids, Diabetes meds, others

Disqualifiers: Pregnancy, Smoking, Surgical menopause, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 34

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Marnie K. McLean, M.S.

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for women who are starting menopause and have not been regularly lifting weights. They should be generally healthy but may have early signs of cardiovascular disease or motor skill issues related to aging. Women with severe health conditions, currently on hormone therapy, or unable to commit to the study schedule are excluded.

Inclusion Criteria

Do not smoke or vape nicotine or marijuana

Are not currently pregnant

Are willing to avoid food 2 hours prior to the morning study visit

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline vascular function and exercise testing, and surveys about sleep, mood, and menopause-specific quality of life. Blood and urine samples are collected.

1 week

1 visit (in-person)

Intervention

Participants randomized to resistance training complete two sessions per week for 16 weeks. Control group receives weekly health education emails.

16 weeks

32 sessions (in-person) for exercise group

Post-Intervention Assessment

Participants complete post-intervention vascular function and exercise testing, and the same surveys as at baseline.

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Resistance Training Intervention

Trial Overview The trial is testing if resistance training (like weightlifting) twice a week can improve blood vessel health in perimenopausal women compared to those receiving educational emails about menopause. The study will also assess changes in mood, sleep quality, and life satisfaction.

How Is the Trial Designed?

Group I: Resistance Training Intervention Experimental Treatment 1 Intervention

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

Group II: Health Education Intervention Active Control 1 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.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+