Back to resultsStrength Training for Osteoporosis Prevention During Early Menopause (STOP-EM)
Primary Purpose
Bone Loss, Bone Loss, Age-related, Osteoporosis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Resistance Training
Sponsored by
About this trial
This is an interventional prevention trial for Bone Loss focused on measuring Exercise, Resistance Training, Strength Training
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Exercise
Control
Arm Description
In-person, supervised resistance training program
Waitlist control group. Will be offered the exercise program following a 9-month wait.
Outcomes
Primary Outcome Measures
Feasibility - Recruitment
Recruitment rates - number of participants recruited per month and number of eligible participants who consented.
Feasibility - Adherence
Protocol adherence (number of exercise sessions participants attend) will be expressed as a percent.
Feasibility - Attrition
Attrition (number of randomized participants with valid outcome data) will be expressed as a percent.
Secondary Outcome Measures
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.
Bone microarchitecture
HR-pQCT will assess trabecular thickness and separation and cortical bone thickness in mm at the distal tibia and radius.
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.
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.
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.
Balance
The four-square-step test assesses dynamic balance.
Aerobic Fitness
The 6-minute walk test assesses aerobic fitness
Estrogen concentration
A blood sample will measure plasma estradiol in pmol/L
Follicle stimulating hormone concentration
A blood sample will measure plasma follicle stimulating hormone (FSH) in IU/L
Vitamin D concentration
A blood sample will measure plasma 25-hydroxyvitamin D in nmol/L
Calcium concentration
A blood sample will measure plasma calcium in mmol/L
Creatinine concentration
A blood sample will measure plasma creatinine in umol/L
Biomarker of bone resorption
A blood sample will measure plasma c-telopeptide (CTx) in ng/L
Biomarker of bone formation
A blood sample will measure plasma procollagen 1 intact N-terminal propeptide (P1NP) in ug/L
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.
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
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
Body mass
Body mass in kg
Height
Height in cm
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05961371
Brief Title
Strength Training for Osteoporosis Prevention During Early Menopause
Acronym
STOP-EM
Official Title
Strength Training for Osteoporosis Prevention During Early Menopause
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Loss, Bone Loss, Age-related, Osteoporosis, Musculoskeletal Diseases
Keywords
Exercise, Resistance Training, Strength Training
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized 1:1 to the exercise or waitlist control group.
Masking
InvestigatorOutcomes Assessor
Masking Description
Investigators and outcome assessors will be masked to the group allocation of participants.
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Experimental
Arm Description
In-person, supervised resistance training program
Arm Title
Control
Arm Type
No Intervention
Arm Description
Waitlist control group. Will be offered the exercise program following a 9-month wait.
Intervention Type
Other
Intervention Name(s)
Resistance Training
Intervention Description
Twice weekly resistance training progressing to 5 sets of 5 repetitions of 80-90% of one repetition maximum.
Primary Outcome Measure Information:
Title
Feasibility - Recruitment
Description
Recruitment rates - number of participants recruited per month and number of eligible participants who consented.
Time Frame
Over 9 months
Title
Feasibility - Adherence
Description
Protocol adherence (number of exercise sessions participants attend) will be expressed as a percent.
Time Frame
Over 9 months
Title
Feasibility - Attrition
Description
Attrition (number of randomized participants with valid outcome data) will be expressed as a percent.
Time Frame
Over 9 months
Secondary Outcome Measure Information:
Title
Volumetric bone mineral density (BMD)
Description
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.
Time Frame
Baseline and 9 months
Title
Bone microarchitecture
Description
HR-pQCT will assess trabecular thickness and separation and cortical bone thickness in mm at the distal tibia and radius.
Time Frame
Baseline and 9 months
Title
Bone strength
Description
Finite element analysis will be applied to HR-pQCT images at the distal tibia and radius to estimate bone strength (failure load) in N.
Time Frame
Baseline and 9 months
Title
areal bone mineral density
Description
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.
Time Frame
Baseline and 9 months
Title
Muscle strength
Description
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.
Time Frame
Baseline and 9 months
Title
Balance
Description
The four-square-step test assesses dynamic balance.
Time Frame
Baseline and 9 months
Title
Aerobic Fitness
Description
The 6-minute walk test assesses aerobic fitness
Time Frame
Baseline and 9 months
Title
Estrogen concentration
Description
A blood sample will measure plasma estradiol in pmol/L
Time Frame
Baseline and 9 months
Title
Follicle stimulating hormone concentration
Description
A blood sample will measure plasma follicle stimulating hormone (FSH) in IU/L
Time Frame
Baseline and 9 months
Title
Vitamin D concentration
Description
A blood sample will measure plasma 25-hydroxyvitamin D in nmol/L
Time Frame
Baseline and 9 months
Title
Calcium concentration
Description
A blood sample will measure plasma calcium in mmol/L
Time Frame
Baseline and 9 months
Title
Creatinine concentration
Description
A blood sample will measure plasma creatinine in umol/L
Time Frame
Baseline and 9 months
Title
Biomarker of bone resorption
Description
A blood sample will measure plasma c-telopeptide (CTx) in ng/L
Time Frame
Baseline and 9 months
Title
Biomarker of bone formation
Description
A blood sample will measure plasma procollagen 1 intact N-terminal propeptide (P1NP) in ug/L
Time Frame
Baseline and 9 months
Title
Physical activity
Description
Physical activity will be assessed by wearing an accelerometer for 7 days to assess moderate to vigorous physical activity in minutes per day.
Time Frame
Baseline and 9 months
Title
Menopausal quality of life
Description
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
Time Frame
Baseline and 9 months
Title
Menopausal symptoms
Description
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
Time Frame
9 months
Title
Body mass
Description
Body mass in kg
Time Frame
Baseline and 9 months
Title
Height
Description
Height in cm
Time Frame
Baseline and 9 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charley Hasselaar
Phone
4032108518
Email
cmhassel@ucalgary.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leigh Gabel, PhD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22344196
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.
Results Reference
background
PubMed Identifier
30861219
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.
Results Reference
result
PubMed Identifier
33357834
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.
Results Reference
result
PubMed Identifier
33536076
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.
Results Reference
result
PubMed Identifier
18160467
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.
Results Reference
result
PubMed Identifier
21735380
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.
Results Reference
result
PubMed Identifier
26243363
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.
Results Reference
result
PubMed Identifier
18414964
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.
Results Reference
result
Learn more about this trial
Strength Training for Osteoporosis Prevention During Early Menopause
We'll reach out to this number within 24 hrs