Strength Training for Osteoporosis Prevention During Early Menopause (STOP-EM)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Musculoskeletal Diseases; Osteoporosis; Bone Loss; Bone Loss, Age-related
• Intervention / Treatment: Other: Resistance Training

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 1N4
      • University of Calgary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise; In-person, supervised resistance training program	Other: Resistance Training; Twice weekly resistance training progressing to 5 sets of 5 repetitions of 80-90% of one repetition maximum.
No Intervention: Control; Waitlist control group. Will be offered the exercise program following a 9-month wait.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility - Recruitment	Recruitment rates - number of participants recruited per month and number of eligible participants who consented.	Over 9 months
Feasibility - Adherence	Protocol adherence (number of exercise sessions participants attend) will be expressed as a percent.	Over 9 months
Feasibility - Attrition	Attrition (number of randomized participants with valid outcome data) will be expressed as a percent.	Over 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
Balance	The four-square-step test assesses dynamic balance.	Baseline and 9 months
Aerobic Fitness	The 6-minute walk test assesses aerobic fitness	Baseline and 9 months
Estrogen concentration	A blood sample will measure plasma estradiol in pmol/L	Baseline and 9 months
Follicle stimulating hormone concentration	A blood sample will measure plasma follicle stimulating hormone (FSH) in IU/L	Baseline and 9 months
Vitamin D concentration	A blood sample will measure plasma 25-hydroxyvitamin D in nmol/L	Baseline and 9 months
Calcium concentration	A blood sample will measure plasma calcium in mmol/L	Baseline and 9 months
Creatinine concentration	A blood sample will measure plasma creatinine in umol/L	Baseline and 9 months
Biomarker of bone resorption	A blood sample will measure plasma c-telopeptide (CTx) in ng/L	Baseline and 9 months
Biomarker of bone formation	A blood sample will measure plasma procollagen 1 intact N-terminal propeptide (P1NP) in ug/L	Baseline and 9 months
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
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
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
Body mass	Body mass in kg	Baseline and 9 months
Height	Height in cm	Baseline and 9 months

Collaborators and Investigators

• Sponsor: University of Calgary
• Investigators: Principal Investigator: Leigh Gabel, PhD, University of Calgary

Publications and helpful links

General Publications

• 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 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: June 26, 2023
• First Submitted That Met QC Criteria: July 17, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Estimated): December 5, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Exercise; Resistance Training; Strength Training
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Bone Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Genital Diseases, Female; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Bone Diseases, Metabolic; Osteoporosis; Musculoskeletal Diseases; Menopause, Premature; Primary Ovarian Insufficiency
• Other Study ID Numbers: REB22-1632

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No