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临床试验/NCT02928562
NCT02928562已完成不适用

The Impaction of Exercise Training on Bone Mineral Density in Patients After Total Knee Arthroplasty

Chang Gung Memorial Hospital2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2013年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
110
试验地点
2
主要终点
Change from baseline bone mineral density

研究概览

简要总结

Rehabilitation after total knee arthroplasty (TKA) should consider control of postoperative pain and swelling, protection of the healing graft, restoration of full range of motion symmetric to the contralateral knee, strengthening of the muscles that stabilize the knee, hip, and trunk, enhancing neuromuscular control, and a gradual progression to functional activities that are required for return to the normal daily life. The effects of concomitant injuries and surgical procedures must also be considered in planning an individualized rehabilitation program. However, it is still unclear regarding the optimal exercise prescription after TKA. In the current study, the investigators plan to develop an exercise protocol and evaluate the result in a multidisciplinary approach, i.e. bone mineral density assessment. The exercise prescription consisted of cyclic exercise, aerobic exercise and resistant training exercise for first, second and third year, respectively. Cyclic exercise is advantaged safety and effectiveness of hydraulic resistance equipment, as well as the exercise can be quantitatively determined. Aerobic exercise is privileged by the cardiopulmonary endurance improvement, along with muscle strengthening in the associated muscle groups. Resistance exercise is specified for the indicated muscle groups, especially knee extensors, flexors, ankle plantar flexor and dorsi flexor in TKA reconstructed patients. The investigators hypothesis that using this cyclic exercise process can improve the body composition, muscle strength, bone mass density, level of oxidative damage indicators, gait performance, quality of life, knee joint range of motion, function of cardiopulmonary and fitness. This project will establish the scientific basis for rehabilitation protocol involving knee 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
65 Years 至 85 Years(Older Adult)
性别
All
接受健康志愿者

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

研究组 & 干预措施

Control

No Intervention

TKA patients without exercise intervention

Exercise

Experimental

TKA patients with exercise intervention ( cyclic exercise, aerobic exercise and resistant training exercise )

干预措施: exercise (Other)

结局指标

主要结局

Change from baseline bone mineral density

时间窗: pre-operation; three month ; six month and nine month after operation; twelve-month follow-up

Bone mineral density measurement is measured by dual-energy x-ray absorptiometry (DXA). Measurements are made over the lumbar spine and over the upper part of the hip and the measurement is assessed at pre-operation, three month, six month and nine month after operation, and twelve-month follow-up.

次要结局

  • Change from baseline KOOS questionnaire assessment(pre-operation; three month ; six month and nine month after operation; twelve-month follow-up)
  • Physical fitness---6-minutes' walk test(pre-operation; three month , six month and nine month after operation; twelve-month follow-up)
  • Physical fitness---30-sec sit to stand(pre-operation; three month ; six month and nine month after operation; twelve-month follow-up)
  • Physical fitness---2.44 m up and go(pre-operation; three month ; six month and nine month after operation; twelve-month follow-up)
  • Motion analysis(pre-operation; three month ; six month and nine month after operation; twelve-month follow-up)
  • Change from baseline lower extremity muscle strength(pre-operation; three month ; six month and nine month after operation; twelve-month follow-up)
  • Change from baseline SF-36 questionnaire assessment(pre-operation; three month ; six month and nine month after operation; twelve-month follow-up)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Robert Wen-Wei Hsu

Honorary Dean

Chang Gung Memorial Hospital

研究点 (2)

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