Stronger: Muscle Strengthening for Menopause

April 16, 2024 updated by: Marily Ann Oppezzo, Stanford University
Menopause is a period of time with increased risk for muscle and bone loss. Very few people strength train regularly at least 2 times per week, and commonly reported barriers include inadequate time and resources, worries of safety, inadequate knowledge base of what moves to do and how to do them. Menopause-aged women may report unique barriers - or perceived facilitators - to strength training. This pilot study will develop and test the feasibility and acceptability of an at-home, band-based, expert-supported strength training intervention.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Women are at particular risk for low muscle mass as they age, because menopause causes a dramatic reduction in circulating estrogen, which accelerates muscle decline. Preserving muscle is one of the single most important factors to maintaining lifelong independence, with bone, metabolic, cardiovascular, and cognitive health benefits. The most critical behavior for growing and preserving muscle is resistance training, and conservative estimates indicate 4 in 5 US adults do not engage in any resistance training. Commonly cited barriers for women include gender-based stigmas, discouragement, negative comments, poor knowledge of how to do resistance training, poor gym accessibility, and difficulty balancing work and family life. Finally, many menopause practitioners note that with bodyweight as a large concern, many women decrease calorie intake and increase cardiovascular (not resistance) training, further compounding muscle loss. This proposed intervention study aims to develop and pilot a muscle health building intervention with and for menopausal women.

Broadly, the investigators will identify the adherence, feasibility, acceptability, and preliminary changes of a resistance training intervention for menopausal women. The investigators will pilot the 3-month "Stronger" intervention, utilizing a protocol co-designed from focus groups. We will recruit women with menopause and randomize them into one of 2 groups: 1) single-session strength training (Stronger); or 2) "Stronger snacks," the same exercises as the single-session training but broken into single-set snack sizes that are performed throughout the week. The investigators hypothesize that the strength snacks will have the highest adherence and be the most behaviorally accessible and acceptable, but post-study interviews will also help us identify motivational differences.

Study Type

Interventional

Enrollment (Estimated)

60

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 Contact

Study Locations

    • California
      • Stanford, California, United States, 94305-7240
        • Stanford University School of Medicine

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
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • one year of no periods or categorized as menopause
  • female at birth
  • English speaking

Exclusion Criteria:

  • unable to perform strength training movements
  • currently performing regular strength training activities or exercise

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Shorter Resistance Training: Stronger Snacks
Home-based strength training exercises would be broken up into shorter segments throughout the day or week (e.g. a "snack" might be 3 sets of body-weight or band-based squats).
Strength exercises (3-4 sets each exercise) videos delivered electronically, participant self-tracks and self-progresses based on effort reported.
Experimental: Single Session Resistance Training: Stronger Sessions
Home-based strength training exercises would be broken up into 3 weekly sessions throughout the week.
Strength exercises (3-4 sets each exercise) videos delivered electronically, participant self-tracks and self-progresses based on effort reported.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of strength exercises the participant logged over the intervention
Time Frame: Total at the end of 3 months
The total number of strength exercises the participant logs is a measure of adherence to the intervention.
Total at the end of 3 months
Liking of the intervention
Time Frame: 3 month
Liking is measured using a 5-point Likert scale from not at all (1) to extremely (5) at the end of the intervention as a measure of acceptability of the intervention.
3 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants completing post 3 month measure / those randomized and consented
Time Frame: 3 months
This measures retention rate; this will be a single ratio determined by the denominator of number of participants randomized and consented collected at baseline, and a numerator of the number of participants who complete post 3 month measures
3 months
Change in total seconds a participant can remain in a wall sit
Time Frame: Change from baseline to 3 months
This measures muscular strength endurance. Each participant will be timed using a video- when they initiate and when they stop maintaining a position of sitting at 90 degrees with their back supported by the wall behind them.
Change from baseline to 3 months
Change in number of full body weight squats in 60 seconds
Time Frame: Change from baseline to 3 months
This measures muscular strength endurance. Each participant will video themselves doing bodyweight squats to reach a chair with a bell on it. Each time they touch the bell will count as a rep.
Change from baseline to 3 months

Collaborators and Investigators

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

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)

August 1, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

April 12, 2024

First Submitted That Met QC Criteria

April 16, 2024

First Posted (Actual)

April 19, 2024

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 75119

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD will be made available after publication of primary outcomes of the pilot study.

IPD Sharing Time Frame

After the primary outcomes of this pilot have been published, deidentified data will be available upon request.

IPD Sharing Access Criteria

proposed use of the data requested is required

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • ANALYTIC_CODE

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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