The Effect of Exercise on Physical Function in Older Women With Osteoporosis and a History of Vertebral Fracture: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 149
- 试验地点
- 2
- 主要终点
- 10 meter habitual walking speed
研究概览
简要总结
The study is a parallel-group single blinded randomized controlled trial, examining the effect of exercise on physical function in older women with osteoporosis and a history of vertebral fracture. The participants will randomly be assigned in a 1:1 ratio to the intervention group and the control group. The intervention will follow newly developed exercise recommendations for people with osteoporosis and vertebral fractures, which states the balance- and strength exercises should be performed at least twice a week. The intervention is a group exercise session circuit program lasting for 12 weeks. The participants will be tested at baseline, and followed up at 3 months and 6 months.
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
- 65 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women over 65 years, living at home, able to walk with or without walking aids
- •having osteoporosis verified by DXA scan (-2,5)
- •at least one vertebral fracture, verified by X-ray
排除标准
- •Health conditions that make it unsafe to exercise
- •not able to understand and speak Norwegian adequately to participate in the intervention
研究组 & 干预措施
Intervention
Intervention consists of strength and balance exercise in group sessions, twice a week for 12 weeks
干预措施: Exercise (Other)
Control
Participants allocated in the control group are instructed to "live as usual"
结局指标
主要结局
10 meter habitual walking speed
时间窗: Up to 18 months
次要结局
- Senior Fitness test(Up to 18 months)
- Functional reach(Up to 18 months)
- Quality of life of participants assessed by the questionnaire Qualeffo 41(Up to 18 months)
- Four Square Step Test(Up to 18 months)
- Short Form -36(Up to 18 months)
- FES-1(Up to 18 months)
- Grip Strength(Up to 18 months)
- IPAQ-SF(Up to 18 months)
- Patient Specific Function Scale(Up to 18 months)
研究者
Brita Stanghelle
phd-student
Oslo Metropolitan University