The Impact of Combination of Aerobic and Resistive Exercise on Activities of Daily Living and Risk of Fall in Osteosarcopenic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Change from Baseline on Skeletal Muscle Mass Measurement at month 1
研究概览
简要总结
The purpose of this study is to assess the efficacy of combination of aerobic and resistive exercise on activities of daily living and risk of fall in osteosarcopenic patients
详细描述
After being informed about the study and potential risk, all patients giving written informed consent will undergo study entry.
to begin with: assessment with bioelectrical body composition analyzer and first exercise and assessment clinical scales
1th month: assessment with bioelectrical body composition analyzer and assessment clinical scales 3th month: assessment with bioelectrical body composition analyzer and assessment clinical scales
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 91 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Over 70 years of age
- •Clinical diagnosis of osteoporosis or osteopenia
- •Independent mobilization
- •Walking speed < 0.8 m / sec
- •Grip strength < 20 kg for women, < 30 kg for men
排除标准
- •Uncontrolled hypertension (systolic blood pressure> 200 mmHg, diastolic blood pressure> 110 mmHg)
- •Uncontrolled diabetes mellitus
- •Stroke, hip fracture, knee and hip arthroplasty, spinal surgery in the last 6 months
- •Severe cardiac arrhythmia
- •Myocardial infarction in the last 6 months
- •Severe dementia and difficulties in cooperation
- •Cardiac pacemaker
- •Acute infection
- •Severe edema
- •Malignancy patients
- •Severe anemia (Hgb <8 mg / dl)
结局指标
主要结局
Change from Baseline on Skeletal Muscle Mass Measurement at month 1
时间窗: Baseline and Month 1
Assessment with bioelectrical body composition analyzer male: SMI\<9,2 kg/m2 female: SMI\<7,4 kg/m2
Change from Baseline on Timed Up and Go Test at month 3
时间窗: Baseline and Month 3
Stand up and walk 3 meters, turn around, walks back to the chair and sit down.14 seconds or longer : high risk for falling
Change from Baseline on Katz Activities of Daily Living Scale at month 3
时间窗: Baseline and Month 3
minimum 0, maximum 6, high scores: better
Change from Baseline on Katz Activities of Daily Living Scale at month 1
时间窗: Baseline and Month 1
minimum 0, maximum 6, high scores: better
Change from Baseline on Short Physical Performance Battery at month 1
时间窗: Baseline and Month 1
0-low perfomance, 12-good performance
Change from Baseline on Berg Balance Test at month 1
时间窗: Baseline and Month 1
maximum 56 point, a score of \< 45 indicates individuals may be at greater risk of falling.
Change from Baseline on Timed Up and Go Test at month 1
时间窗: Baseline and Month 1
Stand up and walk 3 meters, turn around, walks back to the chair and sit down.14 seconds or longer : high risk for falling
Change from Baseline on Five Times Sit to Stand Test at month 1
时间窗: Baseline and Month 1
Lower times: better scores
Change from Baseline on Berg Balance Test at month 3
时间窗: Baseline and Month 3
maximum 56 point, a score of \< 45 indicates individuals may be at greater risk of falling.
Change from Baseline on Skeletal Muscle Mass Measurement at month 3
时间窗: Baseline and Month 3
Assessment with bioelectrical body composition analyzer male: SMI\<9,2 kg/m2 female: SMI\<7,4 kg/m2
Change from Baseline on Short Physical Performance Battery at month 3
时间窗: Baseline and Month 3
0-low perfomance, 12-good performance
Change from Baseline on Five Times Sit to Stand Test at month 3
时间窗: Baseline and Month 3
Lower times: better scores
次要结局
未报告次要终点
研究者
Selda Çiftci
Principal investigator
Sisli Hamidiye Etfal Training and Research Hospital