The Impaction of Exercise Training on Bone Mineral Density in Patients After Total Knee Arthroplasty
1 other identifier
interventional
110
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable knee-osteoarthritis
Started Oct 2013
Longer than P75 for not_applicable knee-osteoarthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 18, 2016
CompletedFirst Posted
Study publicly available on registry
October 10, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2017
CompletedNovember 9, 2017
November 1, 2017
4.1 years
September 18, 2016
November 8, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline bone mineral density
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.
pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
Secondary Outcomes (7)
Change from baseline lower extremity muscle strength
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 SF-36 questionnaire assessment
pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
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
- +2 more secondary outcomes
Study Arms (2)
Control
NO INTERVENTIONTKA patients without exercise intervention
Exercise
EXPERIMENTALTKA patients with exercise intervention ( cyclic exercise, aerobic exercise and resistant training exercise )
Interventions
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sports Medicine Center, Chang Gung Memorial Hospital
Chiayi City, 613, Taiwan
Related Publications (1)
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.
PMID: 29052519DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Wen-Wei HSU, MD
Sports Medicine Center, Chang Gung Memorial Hospital, Chiayi
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Honorary Dean
Study Record Dates
First Submitted
September 18, 2016
First Posted
October 10, 2016
Study Start
October 1, 2013
Primary Completion
October 31, 2017
Study Completion
October 31, 2017
Last Updated
November 9, 2017
Record last verified: 2017-11