Effects of Home Exercise Intervention on Bone Density, Muscle Functions, Quality of Life, and Curve Progression in Girls With Adolescent Idiopathic Scoliosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in BMD after completion of exercise
研究概览
简要总结
Studies with exercise intervention aimed to improve the bone health and muscle functions in patients with AIS were lacking. Evidence suggested that low bone mass and low muscle mass were associated with curve severity and occurrence of AIS. Weight-bearing exercise that aimed to improve musculoskeletal and metabolic health could enhance bone health and muscle mass, and could provide a feasible alternative conservative treatment to prevent curve progression as well as the quality of life in AIS girls. This is a pilot feasibility study for future large randomized controlled trial (RCT) aiming at determining the effects of home based exercise program on improving bone mineral density (BMD), muscle mass and functions, quality of life (QoL), and prevent curve progression in skeletally immature girls with adolescent idiopathic scoliosis (AIS).
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
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 11 Years 至 14 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Cobb Angle greater or equal to 15°
- •Newly diagnosed at the Scoliosis Clinic without prior treatment
- •Cleared for physical activity by doctor
排除标准
- •Scoliosis with any known etiology such as congenital scoliosis, neuromuscular scoliosis, scoliosis of metabolic etiology, scoliosis with skeletal dysplasia, or
- •Known endocrine and connective tissue abnormalities, or
- •Known heart condition or other diseases that could affect the safety of exercise
- •Eating disorders or GI malabsorption disorders or
- •Currently taking medication that affects bone or muscle metabolism
结局指标
主要结局
Change in BMD after completion of exercise
时间窗: Baseline and 6 months
Areal BMD (g/cm2) of non-dominant femoral neck and greater trochanter, and whole body BMD will be measured by DXA (Horizon, Hologic Inc., USA). Standardized scanning procedure provided by the manufacturer will be followed to ensure unified and comparable measurement. Quality assurance is performed by daily calibration against the standard phantoms provided by the manufacturer, with a precision error of 1.9% for BMD value for patient scan and \<1.0% for whole body phantom scan.
Change in BMC after completion of exercise
时间窗: Baseline and 6 months
BMC (g/cm) of non-dominant femoral neck and greater trochanter, and whole body BMC will be measured by DXA (Horizon, Hologic Inc., USA). Standardized scanning procedure provided by the manufacturer will be followed to ensure unified and comparable measurement.
Change in Muscle mass after completion of exercise
时间窗: Baseline and 6 months
Muscle mass will be measurement by whole body less head (WBLH) scan with DXA (Horizon, Hologic Inc., USA). DXA is the current golden standard to the measurement of body composition. Standardized scanning procedure provided by the manufacturer will be followed to ensure unified and comparable measurement.
Change in Anthropometric measurements after completion of exercise
时间窗: Baseline and 6 months
Body height, weight, sitting height, and arm span will be measured with standard stadiometry techniques.
次要结局
- Change in quality of life after completion of exercise(Baseline and 6 months)
- Change in muscle mass 1 year after completion of exercise(Baseline and 18 months)
- Change in clinical features after completion of exercise(Baseline and 6 months)
- Change in quality of life 1 year after completion of exercise(Baseline and 18 months)
- Change in muscle strength after completion of exercise(Baseline and 6 months)
- Change in muscle endurance 1 year after completion of exercise(Baseline and 18 months)
- Change in aerobic fitness after completion of exercise(Baseline and 6 months)
- Change in muscle endurance after completion of exercise(Baseline and 6 months)
- Change in clinical features 1 year after completion of exercise(Baseline and 18 months)
- Change in muscle strength 1 year after completion of exercise(Baseline and 18 months)
- Change in aerobic fitness 1 year after completion of exercise(Baseline and 18 months)
- Change in BMD 1 year after completion of exercise(Baseline and 18 months)
- Change in BMC 1 year after completion of exercise(Baseline and 18 months)
- Change in Anthropometric measurements 1 year after completion of exercise(Baseline and 18 months)
研究者
Man Shan Elisa Tam
Principal Investigator
Chinese University of Hong Kong