PerimenopauseHeARTNCT07022340
Hemodynamics After Resistance Training
A study testing Resistance Training Intervention in people with Perimenopause, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Perimenopause
- What is being tested?
- Resistance Training Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2025to Dec 2026
- 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 40 to 60 years
- Women only
- No healthy volunteers
- Adult
- 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
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 School of Kinesiology
Ann Arbor, Michigan, 48109
Marnie K. McLean, M.S., 734-615-1711, mcmarnie@umich.edu
Abbi D. Lane, Ph.D., 734-647-3843, abbilane@umich.edu
About this study
Official title: Investigating Resistance Training for Vascular Function and Quality of Life in Perimenopausal Women
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.
Read the detailed description
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.
- Conditions
- Perimenopause
- Being tested
- Resistance Training Intervention
- Keywords
- menopause, perimenopause, vascular function, arterial stiffness, endothelial function, resistance exercise training, strength training, mood, sleep, quality of life, cardiovascular disease, estrogen deficiency, exercise
- Medical subject headings
- Cardiovascular Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance Training InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Resistance Training Intervention | Experimental | Participants randomized to resistance training will complete two sessions/week for 16 weeks. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At baseline and the end of the 16 week study period
Secondary outcomes (3)
Mood scores
Mood will be assessed using validated surveys (PROMIS) at baseline and following the 16-week study period.
Measured: At baseline and the end of the 16 week study period
Sleep quality
Sleep quality will be assessed using a validated survey (PSQI) at baseline and following the 16-week study period.
Measured: At baseline and the end of the 16 week study period
Menopause-specific quality of life
Menopause-specific quality of life will be assessed using a validated survey (MENQOL) at baseline and following the 16-week study period
Measured: At baseline and the end of the 16 week study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start6 Jun 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PerimenopauseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abbi Lane, University of Michigan
- Investigators
- Marnie K. McLean, M.S., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07022340
- Sponsor's protocol ID
- HUM00264586
- Acronym
- HeART
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2025
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only deidentified data may be shared. No individual's name or identifiers will be published or shared. Requests for limited datasets will be considered.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Resistance Training for Vascular Function and Quality of Life in Perimenopausal Women
- ClinicalTrials.gov ID
- NCT07022340
- Acronym / sponsor ID
- HeART / HUM00264586
- Conditions
- Perimenopause
- Keywords
- menopause, perimenopause, vascular function, arterial stiffness, endothelial function, resistance exercise training, strength training, mood
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 6 Jun 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Jun 2025 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistance Training Intervention | Experimental | Behavioral: Resistance Training InterventionParticipants randomized to resistance training will complete two sessions/week for 16 weeks. |
| 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. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| Resistance Training InterventionParticipants 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. | Behavioural | Resistance Training Intervention |
Primary outcome
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.
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.
3 secondary outcomes
Mood scores
Time frame: At baseline and the end of the 16 week study period
Sleep quality
Time frame: At baseline and the end of the 16 week study period
Menopause-specific quality of life
Time frame: At baseline and the end of the 16 week study period
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 3 Aug 2026.
- Lifestyle, Exercise, and Arteries Lab - University of MichiganLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Only deidentified data may be shared. No individual's name or identifiers will be published or shared. Requests for limited datasets will be considered.
Related trials for Perimenopause
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Not yet recruiting
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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.
Marnie K. McLean, M.S. principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Training Intervention in people with Perimenopause, 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?
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 3 Aug 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 Marnie K. McLean, M.S. (734-615-1711, mcmarnie@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascular function (time frame: At baseline and the end of the 16 week study period). The study lists 2 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 3 Aug 2026.