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临床试验/NCT03483519
NCT03483519已完成不适用

Efficacy of Preoperative Muscle Training on Postoperative Recovery and Function in Patients Undergoing Total Hip or Knee Replacement

Ottawa Hospital Research Institute2 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2016年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
55
试验地点
2
主要终点
HOOS or KOOS Questionnaire to assess self-reported pain

研究概览

简要总结

The purpose of this study is to assess the effectiveness of a preoperative muscle training program on hip or knee TJA (Total Joint Arthroplasty). It aims to improve hospital discharge readiness and functional capacity in both the short and long-term. One of the key factors affecting recovery after TJA is how well the patient functions before their surgery. Thus, interventions addressing preoperative function are expected to be beneficial.

详细描述

Although total hip or knee joint replacement is beneficial in treating severe hip or knee osteoarthritis, a significant number of patients take longer to recover in the hospital or have a non-optimal quality of life after the surgery. These patients often have difficulties in accomplishing basic essential everyday tasks such as walking and stair climbing, both shortly and long after surgery. It has been previously shown through research that difficulties to do basic tasks before surgery delays recovery and negatively affects long-term function. It has also been shown that these difficulties are associated with reduced strength in hip or knee muscles present before surgery, caused by lack of activity of patients. This study will determine if a hip or knee muscle strengthening exercise program accomplished before surgery can improve hospital recovery, capacity to accomplish basic activities, and quality of life two days, six weeks and six months after joint replacement surgery. If this exercise program is shown to be beneficial, it will be easily used by patients when waiting for their surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18 and older undergoing unilateral total hip or knee arthroplasty due to osteoarthritis;
  • WOMAC functional subscale less than 66.5/100.

排除标准

  • Patients under 18 years of age;
  • Patients undergoing joint revision on the affected side;
  • patients under the same day discharge protocol;
  • Patients undergoing bilateral arthroplasty;
  • Patients suffering from other previously diagnosed lower-limb problems limiting their capacity to accomplish the exercise program;
  • Patients having surgery in less than 16 weeks after verbal consent;
  • Patients unable or unwilling to commit to required study follow-ups;
  • Patients with no fixed address;
  • Patients with a cognitive impairment that may preclude questionnaire completion;
  • Pregnant or suspected pregnant women as dual-energy x-ray (DXA) used in this study may be harmful to a fetus.

结局指标

主要结局

HOOS or KOOS Questionnaire to assess self-reported pain

时间窗: 12 months

The Hip Disability and Osteoarthritis Outcome Score (HOOS) or Knee Injury and Osteoarthritis Outcome Score (KOOS). A standardized set of questions to assess the function of the hip or knee (dependent on which surgery the patient is undergoing). The KOOS/HOOS are comprised of 6 sections: 1) Symptoms (3 items), 2) Stiffness (2 items), 3) Pain (10 items), 4) Function Daily Living (17 items), 5) Function/Sports and Recreation (4 items), 6) Quality of Life (4 items). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.

次要结局

  • Timed Stair Test(12 months)
  • Hip or Knee Muscle Strength(12 months)
  • Timed-Up-and-Go (TUG)(12 months)
  • Generic Health Status measured by the Questionnaire EQ-5D-5L(12 months)
  • Post-surgical Complications(30 days)
  • Length of hospital stay(1 month)
  • Muscle Mass measured with dual-energy x-ray absorptiometry(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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