Strength Training for Osteoporosis Prevention During Early Menopause

N/AActive Not RecruitingNCT05961371

University of Calgary40 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Bone Loss

Eligibility

Sex: FEMALEMin age: 45 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Feasibility - Recruitment

Recruitment rates - number of participants recruited per month and number of eligible participants who consented.

Time frame: Over 9 months

Feasibility - Adherence

Protocol adherence (number of exercise sessions participants attend) will be expressed as a percent.

Time frame: Over 9 months

Feasibility - Attrition

Attrition (number of randomized participants with valid outcome data) will be expressed as a percent.

Time frame: Over 9 months

Secondary Outcomes

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.