The Impaction of Exercise Training on Bone Mineral Density in Patients After Total Knee Arthroplasty
2017年11月8日 更新者：Robert Wen-Wei Hsu、Chang Gung Memorial Hospital
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.
調査の概要
研究の種類
介入
入学 (実際)
110
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Chiayi City、台湾、613
- Sports Medicine Center, Chang Gung Memorial Hospital
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
65年～85年 (高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：Control
TKA patients without exercise intervention
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実験的：Exercise
TKA patients with exercise intervention ( cyclic exercise, aerobic exercise and resistant training exercise )
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cyclic exercise, aerobic exercise and resistant training exercise
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change from baseline bone mineral density
時間枠：pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
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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.
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pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change from baseline lower extremity muscle strength
時間枠：pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
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Lower extremity muscle strength, including extension and flexion of the hip, knee and ankle were tested by the HUMAC NORM system (CSMi, Stoughton, MA) with the eccentric/concentric contraction mode at an angular velocity of 60 degrees/s.Isokinetic tests were performed five times for each participant, and each test was separated by a rest period of 3 min.
The participants are assessed at pre-operation, three month, six month and nine month after operation, and twelve-month follow-up and received verbal encouragement during the exertion of peak torque.
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pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
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Motion analysis
時間枠：pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
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Gait analysis by VICON three-dimensional, 8-camera motion capture system.The outcome measurement is assessed at pre-operation, three month, six month and nine month after operation, and twelve-month follow-up.
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pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
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Change from baseline SF-36 questionnaire assessment
時間枠：pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
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SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
The lower score the more disability.
The higher the score the less disability.
Eight sections including physical function, role limitation due to physical problems, bodily pain, general health, vitality, social functioning, role limitation due to emotional problems, and mental health.
Additionally, the eight health domains can be used to provide a physical component summary and mental component summary score.
The outcome measurement is assessed at pre-operation, three month, six month and nine month after operation, and twelve-month follow-up.
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pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
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Change from baseline KOOS questionnaire assessment
時間枠：pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
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KOOS contains 5 subscales with a total of 42 items: 1) pain, 2) other symptoms, 3) function in daily living (ADL), 4) function in sport and recreation and 5) knee-related quality of life.
Each question receives a score from 0 to 4 and the scores are transformed to a 0-100 score (0, extreme symptoms, 100, no symptoms).
The User's Guide, is available from www.koos.nu.
The outcome measurement is assessed at pre-operation, three month, six month and nine month after operation, and twelve-month follow-up.
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pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
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Physical fitness---6-minutes' walk test
時間枠：pre-operation; three month , six month and nine month after operation; twelve-month follow-up
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The 6-minutes' walk test measures the distance an individual is able to walk over a total of 6 minutes on a hard, flat surface.
The goal is for the individual to walk as far as possible in 6 minutes and is assessed at pre-operation, three month, six month and nine month after operation, and twelve-month follow-up.
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pre-operation; three month , six month and nine month after operation; twelve-month follow-up
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Physical fitness---2.44 m up and go
時間枠：pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
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The 2.44 m up and go test indicates the level of the participant's motor agility and dynamic balance and is assessed at pre-operation, three month, six month and nine month after operation, and twelve-month follow-up.
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pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
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Physical fitness---30-sec sit to stand
時間枠：pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
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30-sec sit to stand (times in 30sec) is assessed lower body strength, needed for numerous tasks such as climbing stairs, walking and getting out of a chair.
Also reduces the chance of falling.
Number of full stands that can be completed in 30 seconds with arms folded across chest and is assessed at pre-operation, three month, six month and nine month after operation, and twelve-month follow-up.
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pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Robert Wen-Wei HSU, MD、Sports Medicine Center, Chang Gung Memorial Hospital, Chiayi
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2013年10月1日
一次修了 (実際)
2017年10月31日
研究の完了 (実際)
2017年10月31日
試験登録日
最初に提出
2016年9月18日
QC基準を満たした最初の提出物
2016年10月7日
最初の投稿 (見積もり)
2016年10月10日
学習記録の更新
投稿された最後の更新 (実際)
2017年11月9日
QC基準を満たした最後の更新が送信されました
2017年11月8日
最終確認日
2017年11月1日
詳しくは
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