Clinical trial NCT06813404: Building Strength for Menopause
Official title: Building Strength for Menopause
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Strength Training Effects
Menopausal Women
Cognitive Function
Keywords: menopausal women, strength training, cognitive function
Lead sponsor: Northeastern University
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 0
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Feasibility pilot study of heavy resistance training for middle-aged, menopausal women.
Primary purpose: OTHER

Brief summary: A pilot study investigating whether heavy resistance training is enjoyable, acceptable, and feasible for middle-aged women undergoing the menopausal transition. Additional outcomes to be assessed include changes to strength and muscle composition as well as changes to cognitive function and self-reported measures of fatigue, cognition, self-efficacy, and mood.


Eligibility criteria: Inclusion Criteria:

* 40-60 years of age at study enrollment
* Currently experiencing symptoms related to menopause
* Low physical activity levels at study enrollment (not meeting CDC guidelines of 150 minutes moderate/75 minutes vigorous activity per week)
* No regular (\>1x per week) participation in heavy resistance training or yoga exercise within the past 6 months
* Physician's consent to participate in strength testing and the exercise program (if deemed necessary)
* Ambulatory
* Absence of health conditions that may be exacerbated by exercise
* Good or corrected vision and hearing
* Intention to remain in the Boston area for the duration of the study
* Willingness to complete study assessments
* Ability to read, write and understand English
* Not currently enrolled in another PA study

Exclusion Criteria:

* Under 40 or over 60 years
* Pregnant or planning to become pregnant
* Moderate to high physical activity levels at enrollment (meeting CDC guidelines)
* Currently participating regularly (\>1x per week) in a heavy resistance training or yoga program
* Non-consent of physician (if deemed necessary)
* Non-ambulatory (e.g. use of walkers, wheelchairs)
* Presence of health conditions that may be exacerbated by exercise (arthritis, musculoskeletal disorders, etc.)
* Problems with vision or hearing
* Intent to move or take an extended (\>2 weeks) vacation during the testing time points (baseline, 4 months)
* Unwilling to complete study assessments
* Currently enrolled in another PA study

Primary outcomes:
measure: Feasibility (adherence)
timeFrame: From enrollment to the end of the exercise intervention at 16 weeks
measure: Feasibility (retention)
timeFrame: From enrollment to the end of the exercise intervention at 16 weeks
measure: Acceptability
timeFrame: From enrollment to the end of the exercise intervention at 16 weeks
Secondary outcomes:
measure: Muscular strength
timeFrame: From baseline testing to the end of the exercise intervention at 16 weeks
measure: Cognitive function (executive function)
timeFrame: From baseline testing to the end of the exercise intervention at 16 weeks
measure: Cognitive function (working memory)
timeFrame: From baseline testing to the end of the exercise intervention at 16 weeks
measure: Cognitive function (memory recall)
timeFrame: From baseline testing to the end of the exercise intervention at 16 weeks
Other outcomes:
measure: Body composition
timeFrame: From baseline testing to the end of the exercise intervention at 16 weeks
Locations:
city: Boston
country: United States
facility: Northeastern University
state: Massachusetts
Study officials:
References: