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NCT Number: NCT07022340

Hemodynamics After Resistance Training

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.

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Key information

Conditions

Perimenopause Behavior Cardiovascular Diseases Motor Activity

Age range

40 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan School of Kinesiology

Ann Arbor, Michigan, 48109, United States

Location status: Recruiting

Location contact

Abbi D. Lane, Ph.D.

CONTACT

[email protected]

734-647-3843

Marnie K. McLean, M.S.

CONTACT

[email protected]

734-615-1711

Marnie K. McLean, M.S.

PRINCIPAL_INVESTIGATOR

About this study

Perimenopause is an important time when heart disease risk increases. Perimenopause is also related to worse health-related quality of life, sleep disruptions, and mood. Poor sleep and mood are both related to cardiovascular disease risk. Resistance exercise is effective at reducing cardiovascular disease risk in premenopausal women, and also improves mood, menopausal symptoms, and sleep quality in post-menopausal women. Resistance exercise does not consistently improve vascular function, such as arterial stiffness and blood vessel reactivity, in post-menopausal women. This study aims to investigate the effect of resistance training intervention on vascular function in perimenopausal women. This study will also determine if resistance training improves other novel cardiovascular disease risk factors that tend to worsen in perimenopause, such as sleep quality, mood, and menopause-specific quality of life.

The investigators will conduct a randomized controlled trial in perimenopausal females. Participants will complete baseline vascular function and exercise testing at baseline. Blood and urine will be collected. Participants will also complete surveys about their sleep, mood, and menopause-specific quality of life. Participants will be randomized to resistance training or control group. Those randomized to resistance training will complete two sessions per week for 16 weeks. The control group will receive a weekly health education email. Following the 16-week intervention or control, participants will complete post-intervention vascular function and exercise testing, and the same surveys as at baseline. Comparisons will be made between the exercise and control groups.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Resistance Training Intervention

Behavioral

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.

Primary outcomes

  1. Vascular function

    Time frame: At baseline and the end of the 16 week study period

    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.

  2. Endothelial Function

    Time frame: At baseline and the end of the 16 week study period

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

Secondary outcomes

  1. Mood scores

    Time frame: At baseline and the end of the 16 week study period

    Mood will be assessed using validated surveys (PROMIS) at baseline and following the 16-week study period.

  2. Sleep quality

    Time frame: At baseline and the end of the 16 week study period

    Sleep quality will be assessed using a validated survey (PSQI) at baseline and following the 16-week study period.

  3. Menopause-specific quality of life

    Time frame: At baseline and the end of the 16 week study period

    Menopause-specific quality of life will be assessed using a validated survey (MENQOL) at baseline and following the 16-week study period

Study contacts

Contact information is provided by the study sponsor or research team.

Abbi D. Lane, Ph.D.

CONTACT

[email protected]

734-647-3843

Marnie K. McLean, M.S.

CONTACT

[email protected]

734-615-1711

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

Investigating Resistance Training for Vascular Function and Quality of Life in Perimenopausal Women

Acronym: HeART

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 15, 2025
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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