Knee Osteoarthritis Clinical Trial
Official title:
The Effect of Exercise Training on Muscle Mass in Patients With Total Knee Arthroplasty
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.
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