Strength Training for Osteoporosis Prevention During Early Menopause

Study Overview
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Brief Summary
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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
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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.

Official Title
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Strength Training for Osteoporosis Prevention During Early Menopause

Conditions
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Bone Loss, Bone Loss, Age-related, Osteoporosis, Musculoskeletal Diseases

Intervention / Treatment
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* Other: Resistance Training


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized 1:1 to the exercise or waitlist control group.
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Resistance Training, Strength Training