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Circulatory Exercise After Total Knee Replacement

3 luglio 2026 aggiornato da: Mariam ibrahim, Assiut University

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

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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

68

Fase

  • Non applicabile

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: standard postoperative TKR rehabilitation (hospital protocol)
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.
Sperimentale: Circulatory Exercise Protocol (in addition to standard rehab)
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Difference in postoperative lower-limb edema between the operated and contralateral limbs measured by standardized limb circumference (cm)
Lasso di tempo: 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.
Baseline/preoperative to postoperative day 14

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Postoperative pain intensity measured by the Numeric Rating Scale (NRS, 0-10) at rest and during activity
Lasso di tempo: 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.
Baseline/preoperative to postoperative day 14
Functional mobility:
Lasso di tempo: 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.

Baseline/preoperative to postoperative day 14
Analgesic consumption
Lasso di tempo: Baseline/preoperative to postoperative day 14
Opioid consumption: record rescue analgesic use
Baseline/preoperative to postoperative day 14
Quadriceps strength via handheld dynamometry.
Lasso di tempo: 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.

Baseline/preoperative to postoperative day 14
Neuromuscular electrical stimulation response
Lasso di tempo: Baseline/preoperative to postoperative day 14
Neuromuscular electrical stimulation response by chattanoga multi-current electrical stimulation.
Baseline/preoperative to postoperative day 14
Patient satisfaction with postoperative recovery measured by a 5-point Likert Scale
Lasso di tempo: 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.
postoperative day 14
Serum Interleukin-6 (IL-6)
Lasso di tempo: 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)

Baseline (pre-operative), 24-48 hours post-operative (peak IL-6 window), Baseline/preoperative to postoperative day 14.
Hemostasis or clotting tests
Lasso di tempo: Baseline/preoperative to postoperative day 14
PT (Prothrombin Time) APTT (Activated Partial Thromboplastin Time) D-dimer Fibrinogen
Baseline/preoperative to postoperative day 14
Serum C-Reactive Protein (CRP)
Lasso di tempo: 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)

Baseline (preoperative), postoperative 24-48 hours, and postoperative day 14.
Serum Interleukin-10 (IL-10)
Lasso di tempo: 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)

Baseline (preoperative), postoperative 24-48 hours, and postoperative day 14.
Serum Tumor Necrosis Factor-alpha (TNF-α)
Lasso di tempo: 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)

Baseline (preoperative), postoperative 24-48 hours, and postoperative day 14.
Prothrombin Time (PT)
Lasso di tempo: 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)

Baseline (preoperative) and postoperative day 14.
Activated Partial Thromboplastin Time (APTT)
Lasso di tempo: 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

Baseline (preoperative) and postoperative day 14.
D-dimer
Lasso di tempo: 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)

Frame: Baseline (preoperative) and postoperative day 14.
Fibrinogen
Lasso di tempo: 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)

Baseline (preoperative) and postoperative day 14.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

16 giugno 2026

Completamento primario (Stimato)

1 maggio 2027

Completamento dello studio (Stimato)

16 maggio 2027

Date di iscrizione allo studio

Primo inviato

4 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

3 luglio 2026

Primo Inserito (Effettivo)

7 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

7 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 luglio 2026

Ultimo verificato

1 marzo 2026

Maggiori informazioni

Termini relativi a questo studio

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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