Strength training for osteoporosis prevention during early menopause (STOP-EM): a pilot study protocol for a single centre randomised waitlisted control trial in Canada
Bibliographic record
Abstract
Introduction 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. Methods and analysis 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. Ethics and dissemination 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. Trail registration number ClinicalTrials.gov: NCT05961371 . (Protocol V.1.2, 28 September 2023)
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.017 | 0.010 |
| Meta-epidemiology (narrow) | 0.003 | 0.002 |
| Meta-epidemiology (broad) | 0.007 | 0.004 |
| Bibliometrics | 0.002 | 0.003 |
| Science and technology studies | 0.003 | 0.002 |
| Scholarly communication | 0.003 | 0.001 |
| Open science | 0.003 | 0.001 |
| Research integrity | 0.005 | 0.003 |
| Insufficient payload (model declined to judge) | 0.048 | 0.004 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".