Skip to content

Building Strength for Menopause

Building Strength for Menopause

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06813404
Enrollment
0
Registered
2025-02-07
Start date
2025-03-01
Completion date
2025-09-01
Last updated
2025-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Strength Training Effects, Menopausal Women, Cognitive Function

Keywords

menopausal women, strength training, cognitive function

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.

Interventions

The heavy resistance training intervention will consist of twice weekly exercise sessions of 60 minutes each.

BEHAVIORALYoga

Twice weekly yoga sessions of 60 minutes each

Sponsors

Northeastern University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Masking description

Data analysis will be blinded such that the analyst does not know which group each result is associated with. Efforts will be made to have final testing blinded, however if resources are limited, final testing will be done by exercise intervention leads.

Intervention model description

Feasibility pilot study of heavy resistance training for middle-aged, menopausal women.

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
AcceptabilityFrom enrollment to the end of the exercise intervention at 16 weeksParticipant enjoyment will be evaluated at the end of each arm, based on self-reported enjoyment after each session, and a final survey for participant feedback on the intervention. Enjoyment will be rated on a Likert scale.
Feasibility (adherence)From enrollment to the end of the exercise intervention at 16 weeksAdherence to the study intervention will be evaluated at the end of each arm, based on recorded attendance. It will be recounted as a percentage.
Feasibility (retention)From enrollment to the end of the exercise intervention at 16 weeksRetention of participants in each group will be evaluated at the end of each arm, based on recorded attendance. It will be recounted as a percentage.

Secondary

MeasureTime frameDescription
Cognitive function (working memory)From baseline testing to the end of the exercise intervention at 16 weeksThe Backward Digit Span test will be used to assess working memory and attention. This test is scored as the longest sequenced reached and passed and the total number of attempts.
Cognitive function (memory recall)From baseline testing to the end of the exercise intervention at 16 weeksThe East Boston Memory Test will be used to assess immediate and delayed recall. The test is scored as the correct number of components recalled from a three-sentence story.
Muscular strengthFrom baseline testing to the end of the exercise intervention at 16 weeksAssessed through 1-repetition maximum testing of two compound lifts: barbell box squat and barbell bench press. Tests will be conducted at baseline and at the end of the intervention for both exercise groups.
Cognitive function (executive function)From baseline testing to the end of the exercise intervention at 16 weeksThe Digit Symbol Substitution test will be used to assess components of executive function such as processing speed, working memory, visuospatial processing, and attention. This is recorded as total number of trials and total number of correct trials in 90 seconds.

Other

MeasureTime frameDescription
Body compositionFrom baseline testing to the end of the exercise intervention at 16 weeksAs an option, participants may complete a DEXA scan to assess body composition. This will be used to assess changes to lean body mass.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026