Strength training for osteoporosis prevention during early menopause (STOP-EM): a pilot study protocol for a single...

Women lose up to 10% of their bone mass around menopause and the decade following. There is a need for proactive approaches to preserve bone mass and quality around menopause. Existing work has found that high-intensity resistance and impact training (HiRIT) can improve bone and muscle measures in late postmenopausal women. However, this has not been investigated in perimenopausal and early postmenopausal women who are in the midst of the menopausal transition.

This study is a 9-month randomised controlled feasibility trial evaluating a HiRIT programme in perimenopausal and early postmenopausal women. The primary objective of this study is to determine the feasibility of HiRIT in 40 perimenopausal and early postmenopausal women (45-60 years). Participants will be randomised 1:1 into a supervised HiRIT exercise intervention and waitlisted control. The primary outcomes are recruitment, retention and adherence to the exercise intervention. Secondary outcomes include bone (bone mineral density, microarchitecture and strength), muscle (mass, strength and power), physical function (balance and aerobic fitness) and quality of life measures. Feasibility will be assessed based on a priori criterion for success and secondary outcomes will be assessed via multiple linear regressions. The study will be considered feasible if>50% of interested and eligible participants are recruited, if there is>60% adherence to the two times per week, 9-month exercise intervention and if at least 65% of the sample complete the final study visit. Feasibility outcomes will be used to inform a larger, future trial aimed at identifying the efficacy of the exercise intervention for improving various health outcomes, including bone density and muscle mass. Secondary exploratory outcomes will provide insight into the effect of exercise on muscle and bone in perimenopausal and early postmenopausal women.

This study has been approved by the Conjoint Health Research Ethics Board of the University of Calgary REB22-1632. The results of this study will be disseminated at national and international conferences and published in academic journals.

ClinicalTrials.gov: NCT05961371. (Protocol V.1.2, 28 September 2023).