Strength Training for Osteoporosis Prevention During Early Menopause

Not Applicable

Active, not recruiting

• Conditions: Bone Loss, Age-related; Osteoporosis; Musculoskeletal Diseases; Bone Loss
• Interventions: Other: Resistance Training

• Registration Number: NCT05961371
• Lead Sponsor: University of Calgary

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.

Study Timeline

• Study First Submitted: 2023-06-26
• Study First Submitted QC: 2023-07-17
• Study First Posted: 2023-07-27
• Study Start: 2023-11-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05
• Primary Completion: 2025-02
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise	Resistance Training	In-person, supervised resistance training program

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Body mass	Baseline and 9 months	Body mass in kg
Calcium concentration	Baseline and 9 months	A blood sample will measure plasma calcium in mmol/L
Creatinine concentration	Baseline and 9 months	A blood sample will measure plasma creatinine in umol/L
Bone microarchitecture	Baseline and 9 months	HR-pQCT will assess trabecular thickness and separation and cortical bone thickness in mm at the distal tibia and radius.
Aerobic Fitness	Baseline and 9 months	The 6-minute walk test assesses aerobic fitness
Vitamin D concentration	Baseline and 9 months	A blood sample will measure plasma 25-hydroxyvitamin D in nmol/L
Biomarker of bone formation	Baseline and 9 months	A blood sample will measure plasma procollagen 1 intact N-terminal propeptide (P1NP) in ug/L
Menopausal quality of life	Baseline and 9 months	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
Muscle strength	Baseline and 9 months	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	Baseline and 9 months	The four-square-step test assesses dynamic balance.
Follicle stimulating hormone concentration	Baseline and 9 months	A blood sample will measure plasma follicle stimulating hormone (FSH) in IU/L
areal bone mineral density	Baseline and 9 months	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.
Biomarker of bone resorption	Baseline and 9 months	A blood sample will measure plasma c-telopeptide (CTx) in ng/L
Bone strength	Baseline and 9 months	Finite element analysis will be applied to HR-pQCT images at the distal tibia and radius to estimate bone strength (failure load) in N.
Estrogen concentration	Baseline and 9 months	A blood sample will measure plasma estradiol in pmol/L
Volumetric bone mineral density (BMD)	Baseline and 9 months	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.
Physical activity	Baseline and 9 months	Physical activity will be assessed by wearing an accelerometer for 7 days to assess moderate to vigorous physical activity in minutes per day.
Menopausal symptoms	9 months	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
Height	Baseline and 9 months	Height in cm

Trial Locations

Locations (1)

University of Calgary; 🇨🇦 Calgary, Alberta, Canada