Feasibility of a Novel Resistance Exercise in Individuals With Osteoporosis
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Bone biomarker
研究概览
简要总结
The aim of the 2 month randomized controlled trial is to investigate the feasibility of a novel progressive muscle resistance exercise in individuals with low bone mass.
详细描述
In 2008, medical cost of osteoporosis and osteoporosis-related fractures was estimated to be $22 billion. This is further expected to rise because of an increase of 20% in population with osteoporosis, amounting to 12 million adults over the age of 50 years, by 2020, out of which 80% will be postmenopausal women. Unfortunately, benefits due to pharmacological interventions have plateaued. Consequently, there is a critical need to identify complementary therapies to enhance the treatment of low bone mass in older adults. The aim of this study is to examine the feasibility of novel progressive muscle resistance exercise in postmenopausal women with low bone mass. Muscle will be assessed via imaging techniques and isokinetic dynamometer. Physical activity will be assessed via activity monitors. Blood will be collected to assess bone and muscle biomarkers. Balance will be assessed via clinical and biomechanical tests. Testing will be performed at 4 time points: baseline, 1 month, 3 month, and 6 months except imaging which will be done at the baseline and 6 months. The findings from this study will help us to understand the feasibility of resistive muscle exercise program in postmenopausal women with low bone mass.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes assessor will be blinded to the group assignment.
入排标准
- 年龄范围
- 55 Years 至 70 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •independent ambulatory
- •diagnosed with low bone mass
排除标准
- •uncontrolled hypertension
- •secondary osteoporosis
- •fragility fracture,
- •clinical or laboratory evidence of hepatic
- •renal disease,
- •uncontrolled disorders of the parathyroid
- •thyroid glands,
- •a history of cancer in the past 5 years,
- •any structured resistance training within the previous year, and
- •past therapy with any drug for osteoporosis,
- •any current therapy for osteoporosis except zoledronic acid,
- •inability to walk independently or
- •any other medical conditions which could restrict the potential participants from full participation as decided by their physician.
研究组 & 干预措施
Control
The control group will be asked to maintain their normal lifestyle and will be advised to continue their standard care of treatment.
Exercise training
The exercise training group will receive progressive muscle resistive exercise, 10 sets of exercises for 2 times per week for a total of 6 months.
干预措施: Exercise training (Other)
结局指标
主要结局
Bone biomarker
时间窗: 2 month
bone formation and resorption marker
次要结局
未报告次要终点
研究者
Harshvardhan Singh, PhD
PRINCIPAL INVESTIGATOR
University of Alabama at Birmingham
