Stronger: Muscle Strengthening for Menopause

NCT06375356 | Not Yet Recruiting

• 1 other identifier: 75119
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Resistance Training

Outcome Measures

Primary Outcomes (2)

• number of strength exercises the participant logged over the intervention

  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

  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 Outcomes (3)

• Number of participants completing post 3 month measure / those randomized and consented

  3 months

• Change in total seconds a participant can remain in a wall sit

  Change from baseline to 3 months

• Change in number of full body weight squats in 60 seconds

  Change from baseline to 3 months

Study Arms (2)

Shorter Resistance Training: Stronger Snacks

EXPERIMENTAL

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).

Behavioral: Resistance Training

Single Session Resistance Training: Stronger Sessions

EXPERIMENTAL

Home-based strength training exercises would be broken up into 3 weekly sessions throughout the week.

Behavioral: Resistance Training

Interventions

Resistance Training BEHAVIORAL

Strength exercises (3-4 sets each exercise) videos delivered electronically, participant self-tracks and self-progresses based on effort reported.

Shorter Resistance Training: Stronger Snacks; Single Session Resistance Training: Stronger Sessions

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305-7240, United States

Location

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Instructor of Medicine

CONTACT

408-314-2629; moppezzo@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor, Med/Stanford Prevention Research Center

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: April 19, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: After the primary outcomes of this pilot have been published, deidentified data will be available upon request.
• Access Criteria: proposed use of the data requested is required

Locations

US (1)