Building Strength for Menopause

Not Applicable

Withdrawn

• Conditions: Strength Training Effects; Menopausal Women; Cognitive Function

• Registration Number: NCT06813404
• Lead Sponsor: Northeastern University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-27
• Study First Submitted QC: 2025-02-05
• Study First Posted: 2025-02-07
• Study Start: 2025-03-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-07
• Primary Completion: 2025-09-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Feasibility (adherence)	From enrollment to the end of the exercise intervention at 16 weeks	Adherence 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 weeks	Retention 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.
Acceptability	From enrollment to the end of the exercise intervention at 16 weeks	Participant 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.

Secondary Outcome Measures

Name	Time	Method
Muscular strength	From baseline testing to the end of the exercise intervention at 16 weeks	Assessed 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 weeks	The 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.
Cognitive function (working memory)	From baseline testing to the end of the exercise intervention at 16 weeks	The 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 weeks	The 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.

Trial Locations

Locations (1)

Northeastern University; 🇺🇸 Boston, Massachusetts, United States