The Effect of Exercise Training on Muscle Mass in Patients With Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Change from baseline muscle mass
研究概览
简要总结
Background:
Total knee arthroplasty (TKA) is one of the most common operations in orthopedics. After surgery, the decline of bone mineral density and muscle mass was proved, oral bisphosphonate is commonly used to prevent BMD loss in clinic treatment, however, the loss of muscle mass can only be maintained with exercise intervention. The goals of TKA rehabilitation should be based on control pain, improve ambulation, maximize the range of motion, develop muscle strength, and provide emotional support. We planned to find out a potential adjuvant effective option in muscle mass for the management of post-TKA. Literature suggested that exercise training has been found to have the considerable effect on TKA. However, no suitable exercise prescription was established on the scientific basis. The current study aimed to find out a potential treatment mode.
Study Rationale:
This project will be performed for consecutive three years, the patients with post-TKA patients are managed with the treadmill exercise training in the first year. In the second year, resistance exercise is prescribed. In the third year, eccentric exercise plus resistance training will be arranged in the exercise group. We will analyze the data of the three years and cross-comparative analysis. A prescription of exercise training, a period of 24 weeks each year, 3 times a week, for each 10 minutes warm-up, 40 minutes exercise training, and 10-minute cool down for exercise prescription
Study Objectives:
To investigate the effect of long-term exercise training, eccentric and resistance exercise on muscle mass in patients with total knee arthroplasty. To monitor the performance index included: physiological indices, muscle mass, ambulation and the quality of life index.
Study Design Duration of Treatment: Total of 6-month exercise intervention in each year. The number of Planned Patients: 35 subjects in each control and exercise group in one year, the total of 210 subjects in three years.
Investigational Product: Automated biochemistry analyzer, Biospace Inbody 7.20 Analysis of body composition instrumentation; Dual Energy X-ray Absorptiometer (DEXA), isokinetic muscle strength measurement, VICON to analysis ambulation, functional fitness, the questionnaire including SF-36, KOOS and VAS pain score.
Endpoints: Data collection in pre-surgery, 3 months, 6 months, 9 months and 12 months after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The inclusion criteria of this study were the patients diagnosed with serious osteoarthritis (OA) and recommended to receive TKA surgery.
排除标准
- •The exclusion criteria were the patients with Diabetes, Neuromusculoskeletal disorder, severe chronic disease, history of fracture of a lower limb, artificial limb, and unsuitable for exercise training
结局指标
主要结局
Change from baseline muscle mass
时间窗: Baseline; three month ; six month and nine month after operation; twelve-month follow-up
Muscle mass measurement is measured by dual-energy x-ray absorptiometry (DXA). DXA measures the muscle mass of the whole body and the measurement is assessed at pre-operation, three months, six months and nine months after the operation, and twelve-month follow-up.
次要结局
- Change from baseline lower extremity muscle strength(Baseline; three month ; six month and nine month after operation; twelve-month follow-up)
- Physical fitness---8 feet up and go(Baseline; three month , six month and nine month after operation; twelve-month follow-up)
- Motion analysis(Baseline; three month ; six month and nine month after operation; twelve-month follow-up)
- Change from baseline KOOS questionnaire assessment(Baseline; three month ; six month and nine month after operation; twelve-month follow-up)
- Physical fitness---6-minutes' walk test(Baseline; three month , six month and nine month after operation; twelve-month follow-up)
- Change from baseline SF-36 questionnaire assessment(Baseline; three month ; six month and nine month after operation; twelve-month follow-up)
- Physical fitness---30-sec sit to stand(Baseline; three month , six month and nine month after operation; twelve-month follow-up)
研究者
Robert Wen-Wei Hsu
Principal Investigator
Chang Gung Memorial Hospital