Clinical trial NCT03339323: The Effect of Exercise Training on Muscle Mass in Patients With Total Knee Arthroplasty
Official title: The Effect of Exercise Training on Muscle Mass in Patients With Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Arthropathy of Knee Joint
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2017-11-13
Enrollment: 210
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* The inclusion criteria of this study were the patients diagnosed with serious osteoarthritis (OA) and recommended to receive TKA surgery.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change from baseline muscle mass
timeFrame: Baseline; three month ; six month and nine month after operation; twelve-month follow-up
Secondary outcomes:
measure: Change from baseline lower extremity muscle strength
timeFrame: Baseline; three month ; six month and nine month after operation; twelve-month follow-up
measure: Motion analysis
timeFrame: Baseline; three month ; six month and nine month after operation; twelve-month follow-up
measure: Change from baseline SF-36 questionnaire assessment
timeFrame: Baseline; three month ; six month and nine month after operation; twelve-month follow-up
measure: Change from baseline KOOS questionnaire assessment
timeFrame: Baseline; three month ; six month and nine month after operation; twelve-month follow-up
measure: Physical fitness---6-minutes' walk test
timeFrame: Baseline; three month , six month and nine month after operation; twelve-month follow-up
measure: Physical fitness---8 feet up and go
timeFrame: Baseline; three month , six month and nine month after operation; twelve-month follow-up
measure: Physical fitness---30-sec sit to stand
timeFrame: Baseline; three month , six month and nine month after operation; twelve-month follow-up
Other outcomes:
Locations:
city: Chiayi City
country: Taiwan
facility: Sports Medicine Center, Chang Gung Memorial Hospital
Study officials:
References: