Boosting Venous Return After Knee Replacement: Effects of a Novel Circulatory Exercise on Early Postoperative Inflammation - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 68
- 主要终点
- Difference in postoperative lower-limb edema between the operated and contralateral limbs measured by standardized limb circumference (cm)
研究概览
简要总结
Total knee replacement is commonly associated with early postoperative inflammation, edema, pain, and reduced mobility. This randomized controlled trial will evaluate whether adding a simple circulatory exercise program to standard postoperative rehabilitation reduces early limb edema and inflammatory response after unilateral primary total knee replacement. Participants will be randomized to standard rehabilitation alone or standard rehabilitation plus seated and supine knee-extension exercises with alternating ankle dorsiflexion. The primary endpoint is change in limb edema measured by standardized limb circumference at postoperative day 14.
详细描述
This is a randomized, parallel-group, assessor-blinded controlled clinical trial. Adults undergoing elective unilateral primary total knee replacement for osteoarthritis will be allocated in a 1:1 ratio to either standard postoperative rehabilitation or standard rehabilitation plus a circulatory exercise protocol. The intervention includes supine leg elevation with ankle pump and knee extension, and seated knee extension with alternating ankle dorsiflexion. The exercise will be performed at approximately 15 cycles per minute, 10 sets of 1 minute, with 60 seconds rest between sets, twice daily for 14 postoperative days. Outcomes include limb circumference, pain, functional mobility, quadriceps strength, inflammatory biomarkers, hemostasis markers, analgesic use, patient satisfaction, and adverse events.
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
- Single (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
- 否
入选标准
- •Adults ≥ 18 years undergoing elective unilateral primary TKR for osteoarthritis.
- •Able to provide informed consent.
- •Able to perform the exercise (cognitively and physically) prior to discharge.
排除标准
- •Preexisting peripheral vascular disease with severe ischemia or venous insufficiency that limits exercise.
- •Contraindication to early active movement per surgeon (e.g., complex surgical fixation limiting motion if present).
- •Severe neurological or cognitive impairment preventing instruction adherence.
- •Inability to comply with follow-up.
结局指标
主要结局
Difference in postoperative lower-limb edema between the operated and contralateral limbs measured by standardized limb circumference (cm)
时间窗: Baseline/preoperative to postoperative day 14
Lower-limb circumference (cm) will be measured bilaterally at standardized anatomical landmarks: 10 cm above the superior border of the patella, at the mid-patellar level, and 20 cm above the superior border of the patella. Measurements will be obtained on both the postoperative limb and the contralateral (sound) limb. Edema will be quantified as the side-to-side difference in circumference and the change from baseline.
次要结局
- Postoperative pain intensity measured by the Numeric Rating Scale (NRS, 0-10) at rest and during activity(Baseline/preoperative to postoperative day 14)
- Functional mobility:(Baseline/preoperative to postoperative day 14)
- Analgesic consumption(Baseline/preoperative to postoperative day 14)
- Serum C-Reactive Protein (CRP)(Baseline (preoperative), postoperative 24-48 hours, and postoperative day 14.)
- Quadriceps strength via handheld dynamometry.(Baseline/preoperative to postoperative day 14)
- Neuromuscular electrical stimulation response(Baseline/preoperative to postoperative day 14)
- Patient satisfaction with postoperative recovery measured by a 5-point Likert Scale(postoperative day 14)
- Serum Interleukin-6 (IL-6)(Baseline (pre-operative), 24-48 hours post-operative (peak IL-6 window), Baseline/preoperative to postoperative day 14.)
- Hemostasis or clotting tests(Baseline/preoperative to postoperative day 14)
- Serum Interleukin-10 (IL-10)(Baseline (preoperative), postoperative 24-48 hours, and postoperative day 14.)
- Serum Tumor Necrosis Factor-alpha (TNF-α)(Baseline (preoperative), postoperative 24-48 hours, and postoperative day 14.)
- Prothrombin Time (PT)(Baseline (preoperative) and postoperative day 14.)
- Activated Partial Thromboplastin Time (APTT)(Baseline (preoperative) and postoperative day 14.)
- D-dimer(Frame: Baseline (preoperative) and postoperative day 14.)
- Fibrinogen(Baseline (preoperative) and postoperative day 14.)
研究者
Mariam ibrahim
Physical Therapist, PhD
Assiut University