Strength Training for Osteoporosis Prevention During Early Menopause
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Feasibility - Adherence
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Investigators and outcome assessors will be masked to the group allocation of participants.
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Feasibility - Adherence
时间窗: Over 9 months
Protocol adherence (number of exercise sessions participants attend) will be expressed as a percent.
Feasibility - Recruitment
时间窗: Over 9 months
Recruitment rates - number of participants recruited per month and number of eligible participants who consented.
Feasibility - Attrition
时间窗: Over 9 months
Attrition (number of randomized participants with valid outcome data) will be expressed as a percent.
次要结局
- Bone microarchitecture(Baseline and 9 months)
- Aerobic Fitness(Baseline and 9 months)
- Vitamin D concentration(Baseline and 9 months)
- Biomarker of bone formation(Baseline and 9 months)
- Menopausal quality of life(Baseline and 9 months)
- Muscle strength(Baseline and 9 months)
- Balance(Baseline and 9 months)
- Follicle stimulating hormone concentration(Baseline and 9 months)
- areal bone mineral density(Baseline and 9 months)
- Biomarker of bone resorption(Baseline and 9 months)
- Bone strength(Baseline and 9 months)
- Volumetric bone mineral density (BMD)(Baseline and 9 months)
- Estrogen concentration(Baseline and 9 months)
- Calcium concentration(Baseline and 9 months)
- Creatinine concentration(Baseline and 9 months)
- Physical activity(Baseline and 9 months)
- Menopausal symptoms(9 months)
- Body mass(Baseline and 9 months)
- Height(Baseline and 9 months)
研究者
Leigh Gabel
Assistant Professor
University of Calgary