NCT00643331已完成2 期
The Effect of Exercise in Postmenopausal Women with Low Bone Density
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Bone density measured using DXA at the lumbar spine and proximal femur
研究概览
简要总结
This clinical trial aims to evaluate the effects of a 12 month gym- and home-based exercise program on bone density and falls risk factors in postmenopausal women with low bone density. It is hypothesised that the exercise program will lead to improvements in bone density and falls risk factors such as balance and muscle strength compared with usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Be aged greater than 50 years
- •Be at least 5 years post menopause (defined as the last normal menstrual bleed)
- •Have osteopenia of the hip defined as a DXA T-score between -1 and -2.5 in one or more regions of the proximal femur (total hip, neck or trochanter regions).
- •Have primary osteopenia
- •Be community dwelling (not in residential care)
- •Be able to attend an exercise program 3 times per week over the 12-month period
- •Be able to read and write English
排除标准
- •Secondary causes of bone loss such as osteomalacia, glucocorticoid medication
- •Co-morbidities that would interfere with participation in exercise such as severe heart or pulmonary disease, inflammatory joint disease, severe osteoarthritis, psychiatric condition
- •Physical or orthopaedic disabilities that would place the subject at risk or limit their ability to perform exercise
- •Spinal osteoporosis defined as DXA T-score <-2.5
- •A past vertebral fracture
- •Body mass index > 35 or <
- •Currently on hormone replacement therapy (HRT)
- •Current smoker
- •Past use of HRT within the past 3 years and for more than 6 months duration
- •Taking medication known to affect bone including oestrogen or steroid hormones
- •Known clinically significant liver or renal disease
- •Cancer within the past 5 years
- •Doing regular strength training and/or weight-bearing exercise at least once per week in past 6 months
- •Unlikely to comply with the intervention protocol
研究组 & 干预措施
1
Experimental
Exercise performed at the gym and at home
干预措施: Exercise (Behavioral)
2
No Intervention
Usual care no additional exercise
结局指标
主要结局
Bone density measured using DXA at the lumbar spine and proximal femur
时间窗: 12 months
次要结局
- Falls risk factors(12 months)
研究者
研究点 (1)
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