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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 27, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 7, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 7, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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