Building Strength for Menopause

NCT ID: NCT06813404

Last Updated: 2025-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2025-09-01

Brief Summary

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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

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Conditions

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Strength Training Effects Menopausal Women Cognitive Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

OTHER

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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First wave of participants (n=30)

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

Group Type EXPERIMENTAL

Heavy resistance training

Intervention Type BEHAVIORAL

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

Yoga

Intervention Type BEHAVIORAL

Twice weekly yoga sessions of 60 minutes each

Second wave of participants (n=30)

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

Group Type EXPERIMENTAL

Heavy resistance training

Intervention Type BEHAVIORAL

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

Yoga

Intervention Type BEHAVIORAL

Twice weekly yoga sessions of 60 minutes each

Interventions

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Heavy resistance training

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

Intervention Type BEHAVIORAL

Yoga

Twice weekly yoga sessions of 60 minutes each

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Northeastern University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Northeastern University

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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IRB# 24-12-12

Identifier Type: -

Identifier Source: org_study_id

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