De Invloed Van Hormoonsubstitutietherapie en Gesuperviseerde Training op Lichaamssamenstelling, Cardiovasculair Risico en Insulinegevoeligheid Bij Postmenopauzale Vrouwen
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 390
- 试验地点
- 1
- 主要终点
- Evaluation of the cardiovascular risk
研究概览
简要总结
This trial investigates whether supervised training in combination with hormonal substitution therapy has an impact on body composition, cardiovascular risk, risk for dementia, osteoporosis and insulin sensitivity in postmenopausal women.
详细描述
270 postmenopausal women will be included. Each woman will perform a 12 to 24 weeks sports program with supervised training exercises.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women (diagnosed by physician) with complaints due to menopause
- •Indication for hormonal substitution therapy (except for the control group)
- •Good general health
- •BMI: 20-30 kg/m2
- •Only the use of cholesterol-, blood pressure- or/and thyroid-regulating medication is permitted
排除标准
- 未提供
研究组 & 干预措施
Supervised training + immediate hormone substitution therapy per SOC
干预措施: Exercise program (Other)
Supervised training + immediate hormone substitution therapy per SOC
干预措施: Hormonal substitution therapy per SOC (Drug)
Supervised training + delayed hormone substitution therapy per SOC
干预措施: Exercise program (Other)
Delayed supervised training + immediate hormone substitution therapy per SOC
干预措施: Hormonal substitution therapy per SOC (Drug)
Supervised training
Subjects who will start hormone substitution therapy in standard of care can participate in the trial and have 50% chance to be randomised in the exercise group.
干预措施: Exercise program (Other)
结局指标
主要结局
Evaluation of the cardiovascular risk
时间窗: +12 weeks; +24 weeks
The cardiovascular risk will be estimated by blood- and urine analysis, blood pressure and a AGE (i.e. Advanced Glycation End products)-reader. There are three timepoints of measurement; once at inclusion, once at 12 weeks, and once at 24 weeks.
Evaluation of the insulin sensitivity
时间窗: +12 weeks, +24 weeks
The insulin sensitivity will be estimated by blood- and urine analysis and a AGE (i.e. Advanced Glycation End products)-reader. There are three timepoints of measurement; once at inclusion, once at 12 weeks, and once at 24 weeks.
次要结局
- Evaluation of the body composition(+12 weeks; +24 weeks)
- Evaluation of the muscle mass(+12 weeks; +24 weeks)