Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07688642

Circulatory Exercise After Total Knee Replacement

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

standard postoperative TKR rehabilitation

Other

Participants will receive standard postoperative total knee replacement rehabilitation according to the local hospital protocol, including early mobilization, ROM exercises, quadriceps activation, ambulation training, and standard pain/edema management as clinically indicated.

Standard Rehabilitation Plus Circulatory Exercise

Other

Participants will receive standard postoperative rehabilitation plus a circulatory exercise protocol including 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/minute, 10 sets of 1 minute, 60 seconds rest between sets, twice daily for 14 postoperative days.

Primary outcomes

  1. Difference in postoperative lower-limb edema between the operated and contralateral limbs measured by standardized limb circumference (cm)

    Time frame: 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.

Secondary outcomes

  1. Postoperative pain intensity measured by the Numeric Rating Scale (NRS, 0-10) at rest and during activity

    Time frame: Baseline/preoperative to postoperative day 14

    Pain intensity will be assessed using an 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Scores will be recorded at rest and during activity.

  2. Functional mobility:

    Time frame: Baseline/preoperative to postoperative day 14

    Timed Up and Go (TUG) (go for 3 meter and come back). Record assistance level and gait aids.

    3-meter walk test at regular base and fast base.

  3. Analgesic consumption

    Time frame: Baseline/preoperative to postoperative day 14

    Opioid consumption: record rescue analgesic use

  4. Quadriceps strength via handheld dynamometry.

    Time frame: Baseline/preoperative to postoperative day 14

    Seated 60 Degrees Knee Flexion Patient position Seated on the edge of the table, with feet not in contact with the ground and knee at 60 degrees of flexion.

    Contact point Posterior aspect of the ankle attachment, at the hook closest to the achilles tendon.

    Device orientation Horizontal, linked to the ankle strap at one end and anchored to a fixed surface by the cable strap at the other, posterior to the patient's leg being tested.

    Position of examiner Adjacent to the patient, in a position to situate the DynaMo and instruct the action.

    Instruction Pull against the DynaMo as hard as you can. 3, 2, 1 - pull, pull, pull and relax.

    Attachments Tension links, Carabiners, Ankle strap, Tension strap.

  5. Neuromuscular electrical stimulation response

    Time frame: Baseline/preoperative to postoperative day 14

    Neuromuscular electrical stimulation response by chattanoga multi-current electrical stimulation.

  6. Patient satisfaction with postoperative recovery measured by a 5-point Likert Scale

    Time frame: postoperative day 14

    Patient satisfaction with postoperative recovery will be assessed on postoperative day 14 using a 5-point Likert Scale, where 1 = very dissatisfied, 2 = dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = satisfied, and 5 = very satisfied.

  7. Serum Interleukin-6 (IL-6)

    Time frame: Baseline (pre-operative), 24-48 hours post-operative (peak IL-6 window), Baseline/preoperative to postoperative day 14.

    Interleukin-6 is a pro-inflammatory cytokine and an early mediator of the surgical stress response. Serum IL-6 will be quantified from peripheral venous blood by ELISA. Higher concentrations indicate a greater systemic inflammatory response; IL-6 peaks at approximately 24-48 hours postoperatively.

    Unit: pg/mL · Reference: < 7 pg/mL (assay-dependent)

  8. Hemostasis or clotting tests

    Time frame: Baseline/preoperative to postoperative day 14

    PT (Prothrombin Time) APTT (Activated Partial Thromboplastin Time) D-dimer Fibrinogen

  9. Serum C-Reactive Protein (CRP)

    Time frame: Baseline (preoperative), postoperative 24-48 hours, and postoperative day 14.

    C-reactive protein is a hepatically synthesized acute-phase reactant produced in response to IL-6 signaling. Serum CRP will be measured from peripheral venous blood by immunoturbidimetric assay. Higher concentrations indicate greater systemic inflammation; CRP peaks later than IL-6 (~48-72 hours).

    Unit: mg/L · Reference: < 10 mg/L (hs-CRP: < 1 low, 1-3 moderate, > 3 high cardiovascular risk)

  10. Serum Interleukin-10 (IL-10)

    Time frame: Baseline (preoperative), postoperative 24-48 hours, and postoperative day 14.

    Interleukin-10 is an anti-inflammatory cytokine mediating the compensatory anti-inflammatory response to surgical injury. Serum IL-10 will be quantified from peripheral venous blood by ELISA. Higher concentrations indicate a greater compensatory anti-inflammatory response.

    Unit: pg/mL · Reference: < 10 pg/mL (often < 5 pg/mL; assay-dependent)

  11. Serum Tumor Necrosis Factor-alpha (TNF-α)

    Time frame: Baseline (preoperative), postoperative 24-48 hours, and postoperative day 14.

    Tumor necrosis factor-alpha is a pro-inflammatory cytokine released early in the innate immune response to tissue injury. Serum TNF-α will be quantified from peripheral venous blood by ELISA. Higher concentrations indicate a greater pro-inflammatory response.

    Unit: pg/mL · Reference: < 8.1 pg/mL (commonly < 15-20 pg/mL; assay-dependent)

  12. Prothrombin Time (PT)

    Time frame: Baseline (preoperative) and postoperative day 14.

    Prothrombin time assesses the extrinsic and common coagulation pathways. PT will be determined on platelet-poor plasma (peripheral venous blood in 3.2% sodium citrate) by an automated clot-based method using a thromboplastin reagent. A prolonged PT indicates impaired extrinsic/common-pathway function.

    Unit: seconds · Reference: 11-13.5 seconds (INR 0.8-1.1)

  13. Activated Partial Thromboplastin Time (APTT)

    Time frame: Baseline (preoperative) and postoperative day 14.

    Activated partial thromboplastin time assesses the intrinsic and common coagulation pathways. APTT will be determined on citrated platelet-poor plasma by an automated clot-based method. A prolonged APTT indicates impaired intrinsic/common-pathway function.

    Unit: seconds · Reference: 25-35 seconds

  14. D-dimer

    Time frame: Frame: Baseline (preoperative) and postoperative day 14.

    D-dimer is a fibrin degradation product reflecting activation of coagulation and fibrinolysis. D-dimer will be measured on citrated plasma by a latex-enhanced immunoturbidimetric assay. Elevated concentrations indicate increased fibrin turnover (hypercoagulable/prothrombotic state or venous thromboembolism).

    Unit: µg/mL FEU · Reference: < 0.50 µg/mL FEU (< 500 ng/mL FEU)

  15. Fibrinogen

    Time frame: Baseline (preoperative) and postoperative day 14.

    Fibrinogen (coagulation factor I) is the soluble precursor of fibrin and an acute-phase reactant. Plasma fibrinogen will be measured on citrated plasma by the Clauss clot-based method. Elevated concentrations reflect an acute-phase/inflammatory response; low concentrations may reflect consumption or dilution and a bleeding tendency.

    Unit: mg/dL · Reference: 200-400 mg/dL (2-4 g/L)

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Boosting Venous Return After Knee Replacement: Effects of a Novel Circulatory Exercise on Early Postoperative Inflammation - A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 7, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.