Clinical trial NCT07022340: Hemodynamics After Resistance Training
Official title: Investigating Resistance Training for Vascular Function and Quality of Life in Perimenopausal Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Perimenopause
Keywords: menopause
perimenopause
vascular function
arterial stiffness
endothelial function
resistance exercise training
strength training
mood
sleep
quality of life
cardiovascular disease
estrogen deficiency
exercise
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2025-06-15
Enrollment: 50
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: * 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

Primary outcomes:
measure: Vascular function
timeFrame: At baseline and the end of the 16 week study period
measure: Endothelial Function
timeFrame: At baseline and the end of the 16 week study period
Secondary outcomes:
measure: Mood scores
timeFrame: At baseline and the end of the 16 week study period
measure: Sleep quality
timeFrame: At baseline and the end of the 16 week study period
measure: Menopause-specific quality of life
timeFrame: At baseline and the end of the 16 week study period
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan School of Kinesiology
state: Michigan
Study officials:
affiliation: University of Michigan
name: Marnie K. McLean, M.S.
role: PRINCIPAL_INVESTIGATOR
References: