Building Strength for Menopause

May 2, 2025 updated by: Northeastern University
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Northeastern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Heavy resistance training
The heavy resistance training intervention will consist of twice weekly exercise sessions of 60 minutes each.
Behavioral: Yoga
Twice weekly yoga sessions of 60 minutes each
Experimental: 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.
Behavioral: Heavy resistance training
The heavy resistance training intervention will consist of twice weekly exercise sessions of 60 minutes each.
Behavioral: Yoga
Twice weekly yoga sessions of 60 minutes each

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility (adherence)
Time Frame: 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.
From enrollment to the end of the exercise intervention at 16 weeks
Feasibility (retention)
Time Frame: 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.
From enrollment to the end of the exercise intervention at 16 weeks
Acceptability
Time Frame: 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.
From enrollment to the end of the exercise intervention at 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscular strength
Time Frame: 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.
From baseline testing to the end of the exercise intervention at 16 weeks
Cognitive function (executive function)
Time Frame: 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.
From baseline testing to the end of the exercise intervention at 16 weeks
Cognitive function (working memory)
Time Frame: 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.
From baseline testing to the end of the exercise intervention at 16 weeks
Cognitive function (memory recall)
Time Frame: 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.
From baseline testing to the end of the exercise intervention at 16 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body composition
Time Frame: From baseline testing to the end of the exercise intervention at 16 weeks
As an option, participants may complete a DEXA scan to assess body composition. This will be used to assess changes to lean body mass.
From baseline testing to the end of the exercise intervention at 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northeastern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

January 27, 2025

First Submitted That Met QC Criteria

February 5, 2025

First Posted (Actual)

February 7, 2025

Study Record Updates

Last Update Posted (Actual)

May 7, 2025

Last Update Submitted That Met QC Criteria

May 2, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB# 24-12-12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be de-identified

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cognitive Function

Clinical Trials on Heavy resistance training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe