Clinical trial NCT02928562: The Impaction of Exercise Training on Bone Mineral Density in Patients After Total Knee Arthroplasty
Official title: The Impaction of Exercise Training on Bone Mineral Density in Patients After Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Arthropathy of Knee
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2016-10-10
Enrollment: 110
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


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 bone mineral density
timeFrame: pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
Secondary outcomes:
measure: Change from baseline lower extremity muscle strength
timeFrame: pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
measure: Motion analysis
timeFrame: pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
measure: Change from baseline SF-36 questionnaire assessment
timeFrame: pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
measure: Change from baseline KOOS questionnaire assessment
timeFrame: pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
measure: Physical fitness---6-minutes' walk test
timeFrame: pre-operation; three month , six month and nine month after operation; twelve-month follow-up
measure: Physical fitness---2.44 m up and go
timeFrame: pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
measure: Physical fitness---30-sec sit to stand
timeFrame: pre-operation; 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:
affiliation: Sports Medicine Center, Chang Gung Memorial Hospital, Chiayi
name: Robert Wen-Wei HSU, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hsu WH, Hsu WB, Shen WJ, Lin ZR, Chang SH, Hsu RW. Circuit training enhances function in patients undergoing total knee arthroplasty: a retrospective cohort study. J Orthop Surg Res. 2017 Oct 19;12(1):156. doi: 10.1186/s13018-017-0654-4.