Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2026-01-01 @ 1:10 PM
Study NCT ID:
NCT06375356
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-08
First Post:
2024-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stronger: Muscle Strengthening for Menopause
Sponsor:
Stanford University
Organization:
Study Overview
Official Title:
Stronger: Muscle Strengthening for Menopause
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: