Strength Training for Osteoporosis Prevention During Early Menopause
NCT ID: NCT05961371
Last Updated: 2024-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
40 participants
INTERVENTIONAL
2023-11-01
2025-06-30
Brief Summary
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-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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Exercise
In-person, supervised resistance training program
Resistance Training
Twice weekly resistance training progressing to 5 sets of 5 repetitions of 80-90% of one repetition maximum.
Control
Waitlist control group. Will be offered the exercise program following a 9-month wait.
No interventions assigned to this group
Interventions
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Resistance Training
Twice weekly resistance training progressing to 5 sets of 5 repetitions of 80-90% of one repetition maximum.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
45 Years
60 Years
FEMALE
Yes
Sponsors
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University of Calgary
OTHER
Responsible Party
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Leigh Gabel
Assistant Professor
Principal Investigators
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Leigh Gabel, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Locations
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University of Calgary
Calgary, Alberta, Canada
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Alexander CJ, Kaluta L, Whitman PW, Billington EO, Burt LA, Gabel L. Strength training for osteoporosis prevention during early menopause (STOP-EM): a pilot study protocol for a single centre randomised waitlisted control trial in Canada. BMJ Open. 2025 Feb 5;15(2):e093711. doi: 10.1136/bmjopen-2024-093711.
Other Identifiers
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REB22-1632
Identifier Type: -
Identifier Source: org_study_id