Building Strength for Menopause

Northeastern University

Status: Withdrawn

Conditions: Menopausal Women; Cognitive Function; Strength Training Effects

Treatments: Behavioral: Yoga; Behavioral: Heavy resistance training

Study type: Interventional

Funder types: Other

Identifiers

NCT06813404

IRB# 24-12-12

Details and patient eligibility

About

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.

Sex: Female

Ages: 40 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

First wave of participants (n=30)

Experimental group

Description:

This arm is the first round of the exercise intervention, conducted with half (n=30) the anticipated number of participants.

Treatment:

Behavioral: Heavy resistance training

Behavioral: Yoga

Second wave of participants (n=30)

Experimental group

Description:

This arm is the second round of participants (n=30) who will receive the same intervention as the first wave.

Treatment:

Behavioral: Heavy resistance training

Behavioral: Yoga