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The Impaction of Exercise Training on Bone Mineral Density in Patients After Total Knee Arthroplasty

2017년 11월 8일 업데이트: 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.

연구 개요

상태

완전한

개입 / 치료

연구 유형

중재적

등록 (실제)

110

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Chiayi City, 대만, 613
        • Sports Medicine Center, Chang Gung Memorial Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

65년 (고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 기초 과학
  • 할당: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
간섭 없음: Control
TKA patients without exercise intervention
실험적: Exercise
TKA patients with exercise intervention ( cyclic exercise, aerobic exercise and resistant training exercise )
cyclic exercise, aerobic exercise and resistant training exercise

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change from baseline bone mineral density
기간: pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
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

2차 결과 측정

결과 측정
측정값 설명
기간
Change from baseline lower extremity muscle strength
기간: pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
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.
pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
Motion analysis
기간: pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
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.
pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
Change from baseline SF-36 questionnaire assessment
기간: pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
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.
pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
Change from baseline KOOS questionnaire assessment
기간: pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
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.
pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
Physical fitness---6-minutes' walk test
기간: pre-operation; three month , six month and nine month after operation; twelve-month follow-up
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.
pre-operation; three month , six month and nine month after operation; twelve-month follow-up
Physical fitness---2.44 m up and go
기간: pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
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.
pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
Physical fitness---30-sec sit to stand
기간: pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
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.
pre-operation; three month ; six month and nine month after operation; twelve-month follow-up

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Robert Wen-Wei HSU, MD, Sports Medicine Center, Chang Gung Memorial Hospital, Chiayi

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2013년 10월 1일

기본 완료 (실제)

2017년 10월 31일

연구 완료 (실제)

2017년 10월 31일

연구 등록 날짜

최초 제출

2016년 9월 18일

QC 기준을 충족하는 최초 제출

2016년 10월 7일

처음 게시됨 (추정)

2016년 10월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2017년 11월 9일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 11월 8일

마지막으로 확인됨

2017년 11월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • CORPG6C0021-23

개별 참가자 데이터(IPD) 계획

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미정

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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