Strength Training for Osteoporosis Prevention During Early Menopause

Osteoporosis Clinical Trial

— STOP-EM  

Official title:

Strength Training for Osteoporosis Prevention During Early Menopause

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05961371
• Other study ID #: REB22-1632
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: June 2025

Study information

• Verified date: November 2023
• Source: University of Calgary
• Contact: Charley Hasselaar
• Phone: 4032108518
• Email: cmhassel[@]ucalgary.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Bone Loss
• Bone Loss, Age-related
• Menopause, Premature
• Musculoskeletal Diseases
• Osteoporosis
• Primary Ovarian Insufficiency

Intervention

Other:
• Resistance Training
Twice weekly resistance training progressing to 5 sets of 5 repetitions of 80-90% of one repetition maximum.

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

References & Publications (8)

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

Outcome

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