The Effectiveness of a Patient-navigation-based Preoperative Rehabilitation Exercise Program in Patients Undergoing Total Knee Arthroplasty: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- knee osteoarthritis severity
研究概览
简要总结
This study aimed to assess the effectiveness of a patient navigation-based preoperative rehabilitation exercise program for patients undergoing total knee arthroplasty.
详细描述
Participants were recruited from among patients newly admitted to the orthopaedic ward who met the selection criteria. Participants who provided written informed consent completed a survey collecting demographic and clinical information, followed by a baseline assessment (T0). Subsequently, they were randomly assigned to either the control group or the experimental group. Participants in both groups received standardised, identical inpatient rehabilitation and nursing services throughout their hospitalisation. From admission day to surgery day (preoperative), control group participants will receive an autonomous preoperative rehabilitation exercise programme, while experimental group participants will receive a patient-navigation-based preoperative rehabilitation exercise programme
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients diagnosed with knee osteoarthritis (KOA) scheduled to undergo primary unilateral total knee arthroplasty (TKA)
- •Assessed by the attending physician as medically fit to tolerate preoperative rehabilitation exercise, possessing effective communication skills, and capable of cooperating with all required examinations and assessments
- •Assessed as capable (either the patient or their caregiver) of using a smartphone to receive information
排除标准
- •Individuals unable to cooperate due to impaired consciousness, cognitive impairment, or similar conditions
- •Concurrent severe comorbidities such as liver cirrhosis, respiratory failure, renal failure, malignant tumors, trauma, etc.
- •History of significant neuromuscular disorders or other joint diseases deemed by the attending physician to affect joint function
- •a time interval of greater than 7 days or less than 3 days between the admission day date and the scheduled surgery date;
- •Currently undergoing systematic lower limb functional exercise training within the past four weeks
研究组 & 干预措施
Autonomous preoperative rehabilitation exercise program
Participants will receive an autonomous preoperative rehabilitation program from admission day to surgery day (preoperative).
干预措施: Autonomous preoperative rehabilitation exercises (Other)
Patient-navigation-based preoperative rehabilitation exercise program
Participants will receive a patient-navigation-based preoperative rehabilitation exercise programme from admission day to surgery day (preoperative).
干预措施: The navigator provided full-period preoperative rehabilitation exercise guidance+navigation services (Other)
结局指标
主要结局
knee osteoarthritis severity
时间窗: Outcome will be measured five times: hospital admission (baseline, T0), surgery day (preoperative) (T1),1 weeks after the operation (T2),2 weeks after the operation (T3),and 4 weeks after the operation (T4)
Knee osteoarthritis severity will be measured using the Chinese version of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Scale. The scale consists of 24 items divided into three subscales: pain (5 items), stiffness (2 items), and physical function (17 items). Each item is scored on a scale of 0 to 4. The scores are recoded into a 96-point total scale, where higher scores indicate greater severity of knee osteoarthritis.
次要结局
- Exercise adherence(Outcome will be measured five times: hospital admission (baseline, T0), surgery day (preoperative) (T1),1 weeks after the operation (T2),2 weeks after the operation (T3),and 4 weeks after the operation (T4))
- Self-efficacy(Outcome will be measured five times: hospital admission (baseline, T0), surgery day (preoperative) (T1),1 weeks after the operation (T2),2 weeks after the operation (T3),and 4 weeks after the operation (T4))
- Knee joint function(Outcome will be measured five times: hospital admission (baseline, T0), surgery day (preoperative) (T1),1 weeks after the operation (T2),2 weeks after the operation (T3),and 4 weeks after the operation (T4))
- Knee range of motion (ROM)(Outcome will be measured five times: hospital admission (baseline, T0), surgery day (preoperative) (T1),1 weeks after the operation (T2),2 weeks after the operation (T3),and 4 weeks after the operation (T4))
- Pain intensity(Outcome will be measured five times: hospital admission (baseline, T0), surgery day (preoperative) (T1),1 weeks after the operation (T2),2 weeks after the operation (T3),and 4 weeks after the operation (T4))
研究者
Anna Sun
Nurse Practitioner
First Affiliated Hospital of Jinan University