Osteoporosis Clinical Trial
— STOP-EMOfficial title:
Strength Training for Osteoporosis Prevention During Early Menopause
NCT number | NCT05961371 |
Other study ID # | REB22-1632 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | November 1, 2023 |
Est. completion date | June 2025 |
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | June 2025 |
Est. primary completion date | June 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 45 Years to 60 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | University of Calgary | Calgary | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Calgary |
Canada,
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 — View 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. — View 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. — View 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. — View 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. — View 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 B — View 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 — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility - Recruitment | Recruitment rates - number of participants recruited per month and number of eligible participants who consented. | Over 9 months | |
Primary | Feasibility - Adherence | Protocol adherence (number of exercise sessions participants attend) will be expressed as a percent. | Over 9 months | |
Primary | Feasibility - Attrition | Attrition (number of randomized participants with valid outcome data) will be expressed as a percent. | Over 9 months | |
Secondary | Volumetric bone mineral density (BMD) | High-resolution peripheral quantitative computed tomography (HR-pQCT) will assess total, trabecular, and cortical BMD in mg/cm^3 at the distal tibia and radius. | Baseline and 9 months | |
Secondary | Bone microarchitecture | HR-pQCT will assess trabecular thickness and separation and cortical bone thickness in mm at the distal tibia and radius. | Baseline and 9 months | |
Secondary | Bone strength | Finite element analysis will be applied to HR-pQCT images at the distal tibia and radius to estimate bone strength (failure load) in N. | Baseline and 9 months | |
Secondary | areal bone mineral density | Dual X-ray absorptiometry (DXA) will measure areal bone mineral density (aBMD) in mg/cm^2 for the left hip (total hip and femoral neck), lumbar spine, and whole body. | Baseline and 9 months | |
Secondary | Muscle strength | Muscle strength testing will include max voluntary contractions of the knee extensors using an isometric dynamometer. Hand grip strength will be measured using a handgrip dynamometer. | Baseline and 9 months | |
Secondary | Balance | The four-square-step test assesses dynamic balance. | Baseline and 9 months | |
Secondary | Aerobic Fitness | The 6-minute walk test assesses aerobic fitness | Baseline and 9 months | |
Secondary | Estrogen concentration | A blood sample will measure plasma estradiol in pmol/L | Baseline and 9 months | |
Secondary | Follicle stimulating hormone concentration | A blood sample will measure plasma follicle stimulating hormone (FSH) in IU/L | Baseline and 9 months | |
Secondary | Vitamin D concentration | A blood sample will measure plasma 25-hydroxyvitamin D in nmol/L | Baseline and 9 months | |
Secondary | Calcium concentration | A blood sample will measure plasma calcium in mmol/L | Baseline and 9 months | |
Secondary | Creatinine concentration | A blood sample will measure plasma creatinine in umol/L | Baseline and 9 months | |
Secondary | Biomarker of bone resorption | A blood sample will measure plasma c-telopeptide (CTx) in ng/L | Baseline and 9 months | |
Secondary | Biomarker of bone formation | A blood sample will measure plasma procollagen 1 intact N-terminal propeptide (P1NP) in ug/L | Baseline and 9 months | |
Secondary | Physical activity | Physical activity will be assessed by wearing an accelerometer for 7 days to assess moderate to vigorous physical activity in minutes per day. | Baseline and 9 months | |
Secondary | Menopausal quality of life | Menopausal symptoms will be evaluated through the menopause-specific quality of life questionnaire with a minimum score of 0 and maximum score of 174 and a higher score indicating poorer outcomes | Baseline and 9 months | |
Secondary | Menopausal symptoms | Menopausal symptoms will be evaluated through the menopause symptoms treatment satisfaction questionnaire with a minimum score of 0 and maximum score of 40 and a higher score indicating poorer outcomes | 9 months | |
Secondary | Body mass | Body mass in kg | Baseline and 9 months | |
Secondary | Height | Height in cm | Baseline and 9 months |
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