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Circulatory Exercise After Total Knee Replacement

3 de julho de 2026 atualizado por: 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.

Visão geral do estudo

Descrição detalhada

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 de estudo

Intervencional

Inscrição (Estimado)

68

Estágio

  • Não aplicável

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: 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.
Experimental: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Difference in postoperative lower-limb edema between the operated and contralateral limbs measured by standardized limb circumference (cm)
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Postoperative pain intensity measured by the Numeric Rating Scale (NRS, 0-10) at rest and during activity
Prazo: 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:
Prazo: 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
Prazo: Baseline/preoperative to postoperative day 14
Opioid consumption: record rescue analgesic use
Baseline/preoperative to postoperative day 14
Quadriceps strength via handheld dynamometry.
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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.

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

16 de junho de 2026

Conclusão Primária (Estimado)

1 de maio de 2027

Conclusão do estudo (Estimado)

16 de maio de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

4 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

3 de julho de 2026

Primeira postagem (Real)

7 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

7 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de julho de 2026

Última verificação

1 de março de 2026

Mais Informações

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Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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