Clinical trial NCT05961371: Strength Training for Osteoporosis Prevention During Early Menopause
Official title: Strength Training for Osteoporosis Prevention During Early Menopause
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Bone Loss
Bone Loss, Age-related
Osteoporosis
Musculoskeletal Diseases
Keywords: Exercise
Resistance Training
Strength Training
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 40
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized 1:1 to the exercise or waitlist control group.
Primary purpose: PREVENTION

Brief summary: The goal of this clinical pilot trial is to learn about the feasibility of a high-intensity resistance training intervention in peri- and early menopausal females. The main question it aims to answer are:

-Is a 9-month resistance training intervention feasible (e.g., recruitment rates, protocol adherence, attrition)

Secondary aims include examining changes in bone health, muscle strength, and menopausal symptoms.

Participants will participate in a 9-month progressive, supervised, resistance training intervention. Researchers will compare secondary outcomes between the exercise group and a wait-list control group.

Detailed description: The STOP-EM trial will examine a 9-month supervised, progressive, resistance training program in peri- and early menopausal females. Primary outcomes include recruitment rates, protocol adherence, and attrition. A waitlist control group will allow us to examine the effect of the exercise program on bone density, structure, and strength, muscle strength, and menopausal symptoms. Participants will be randomized to the exercise or control group. The exercise group will attend twice weekly, in-person, supervised, progressive resistance training and build up to 80-90% of estimated 1 repetition maximum (1RM). The study will take place at the University of Calgary. Findings will be used to decide whether to continue to the definitive trial.

Eligibility criteria: Inclusion Criteria:

* 45-60 years old.
* Menopause status of peri- or early menopausal: stages -2 or -1 of the stages for reproductive aging 10+ staging system or are within 5 years of their last known menses.

Exclusion Criteria:

* Females who are pregnant or planning pregnancy within the next year.
* Orthopaedic conditions that may be made worse with exercise.
* Has low back pain, hypertension, lipidemia, diabetes, or cardiovascular disease.
* Has a history of metabolic bone disease.
* Has had an osteoporotic fracture within the last 5 years.
* Had previous treatment with osteoporosis pharmacotherapy.
* Has active glucocorticoid use.
* Is currently participating in progressive resistance training or has in the previous 6 months.
* Has low serum vitamin D (25(OH)D) \< 30 nmol/L or serum calcium \<2.10 mmol/L.

Primary outcomes:
measure: Feasibility - Recruitment
timeFrame: Over 9 months
measure: Feasibility - Adherence
timeFrame: Over 9 months
measure: Feasibility - Attrition
timeFrame: Over 9 months
Secondary outcomes:
measure: Volumetric bone mineral density (BMD)
timeFrame: Baseline and 9 months
measure: Bone microarchitecture
timeFrame: Baseline and 9 months
measure: Bone strength
timeFrame: Baseline and 9 months
measure: areal bone mineral density
timeFrame: Baseline and 9 months
measure: Muscle strength
timeFrame: Baseline and 9 months
measure: Balance
timeFrame: Baseline and 9 months
measure: Aerobic Fitness
timeFrame: Baseline and 9 months
measure: Estrogen concentration
timeFrame: Baseline and 9 months
measure: Follicle stimulating hormone concentration
timeFrame: Baseline and 9 months
measure: Vitamin D concentration
timeFrame: Baseline and 9 months
measure: Calcium concentration
timeFrame: Baseline and 9 months
measure: Creatinine concentration
timeFrame: Baseline and 9 months
measure: Biomarker of bone resorption
timeFrame: Baseline and 9 months
measure: Biomarker of bone formation
timeFrame: Baseline and 9 months
measure: Physical activity
timeFrame: Baseline and 9 months
measure: Menopausal quality of life
timeFrame: Baseline and 9 months
measure: Menopausal symptoms
timeFrame: 9 months
measure: Body mass
timeFrame: Baseline and 9 months
measure: Height
timeFrame: Baseline and 9 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Leigh Gabel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Watson S, Weeks B, Weis L, Harding A, Horan S, Beck B. High-Intensity Resistance and Impact Training Improves Bone Mineral Density and Physical Function in Postmenopausal Women With Osteopenia and Osteoporosis: The LIFTMOR Randomized Controlled Trial. J Bone Miner Res. 2019 Mar;34(3):572. doi: 10.1002/jbmr.3659. Epub 2019 Feb 25. No abstract available.
citation: Kistler-Fischbacher M, Weeks BK, Beck BR. The effect of exercise intensity on bone in postmenopausal women (part 2): A meta-analysis. Bone. 2021 Feb;143:115697. doi: 10.1016/j.bone.2020.115697. Epub 2020 Dec 24.
citation: Lewis M, Bromley K, Sutton CJ, McCray G, Myers HL, Lancaster GA. Determining sample size for progression criteria for pragmatic pilot RCTs: the hypothesis test strikes back! Pilot Feasibility Stud. 2021 Feb 3;7(1):40. doi: 10.1186/s40814-021-00770-x.
citation: Finkelstein JS, Brockwell SE, Mehta V, Greendale GA, Sowers MR, Ettinger B, Lo JC, Johnston JM, Cauley JA, Danielson ME, Neer RM. Bone mineral density changes during the menopause transition in a multiethnic cohort of women. J Clin Endocrinol Metab. 2008 Mar;93(3):861-8. doi: 10.1210/jc.2007-1876. Epub 2007 Dec 26.
citation: Howe TE, Shea B, Dawson LJ, Downie F, Murray A, Ross C, Harbour RT, Caldwell LM, Creed G. Exercise for preventing and treating osteoporosis in postmenopausal women. Cochrane Database Syst Rev. 2011 Jul 6;(7):CD000333. doi: 10.1002/14651858.CD000333.pub2.
citation: Watson SL, Weeks BK, Weis LJ, Horan SA, Beck BR. Heavy resistance training is safe and improves bone, function, and stature in postmenopausal women with low to very low bone mass: novel early findings from the LIFTMOR trial. Osteoporos Int. 2015 Dec;26(12):2889-94. doi: 10.1007/s00198-015-3263-2. Epub 2015 Aug 5.
citation: Weeks BK, Beck BR. The BPAQ: a bone-specific physical activity assessment instrument. Osteoporos Int. 2008 Nov;19(11):1567-77. doi: 10.1007/s00198-008-0606-2. Epub 2008 Apr 15.
citation: Harlow SD, Gass M, Hall JE, Lobo R, Maki P, Rebar RW, Sherman S, Sluss PM, de Villiers TJ; STRAW + 10 Collaborative Group. Executive summary of the Stages of Reproductive Aging Workshop + 10: addressing the unfinished agenda of staging reproductive aging. J Clin Endocrinol Metab. 2012 Apr;97(4):1159-68. doi: 10.1210/jc.2011-3362. Epub 2012 Feb 16.