Stronger: Muscle Strengthening for Menopause

Resistance Training Clinical Trial

Official title:

Stronger: Muscle Strengthening for Menopause

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06375356
• Other study ID #: 75119
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2024
• Est. completion date: August 2026

Study information

• Verified date: April 2024
• Source: Stanford University
• Contact: Instructor of Medicine
• Phone: 408-314-2629
• Email: moppezzo[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: August 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Resistance Training

Intervention

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

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Number of participants completing post 3 month measure / those randomized and consented	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
Secondary	Change in total seconds a participant can remain in a wall sit	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
Secondary	Change in number of full body weight squats in 60 seconds	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