Clinical trial NCT06375356: Stronger: Muscle Strengthening for Menopause
Official title: Stronger: Muscle Strengthening for Menopause
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Resistance Training
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2024-04-19
Enrollment: 60
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: number of strength exercises the participant logged over the intervention
timeFrame: Total at the end of 3 months
measure: Liking of the intervention
timeFrame: 3 month
Secondary outcomes:
measure: Number of participants completing post 3 month measure / those randomized and consented
timeFrame: 3 months
measure: Change in total seconds a participant can remain in a wall sit
timeFrame: Change from baseline to 3 months
measure: Change in number of full body weight squats in 60 seconds
timeFrame: Change from baseline to 3 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
References: