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Total Knee ReplacementNCT07688642

Circulatory Exercise After Total Knee Replacement

A study testing standard postoperative TKR rehabilitation and Standard Rehabilitation Plus Circulatory Exercise in people with Total Knee Replacement and Knee Osteoarthritis, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
standard postoperative TKR rehabilitation and Standard Rehabilitation Plus Circulatory Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
No sites listed yet
Study dates
16 Jun 2026to 16 May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

About this study

Official title: 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.

Read the detailed description

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.

Being tested
standard postoperative TKR rehabilitation, Standard Rehabilitation Plus Circulatory Exercise
Keywords
Total knee arthroplasty, Total knee replacement, Circulatory exercise, Venous return, Ankle pump exercise, Postoperative edema, Postoperative inflammation, Rehabilitation
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • standard postoperative TKR rehabilitationOther

    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 ExerciseOther

    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.

Study groups in NCT07688642
Study groupRoleWhat they receive
standard postoperative TKR rehabilitation (hospital protocol)Active comparatorNot described
Receives: Other: standard postoperative TKR rehabilitation
Circulatory Exercise Protocol (in addition to standard rehab)ExperimentalNot described
Receives: Other: Standard Rehabilitation Plus Circulatory Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: Baseline/preoperative to postoperative day 14

Secondary outcomes (15)
  1. Postoperative pain intensity measured by the Numeric Rating Scale (NRS, 0-10) at rest and during activity

    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.

    Measured: Baseline/preoperative to postoperative day 14

  2. Functional mobility:

    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.

    Measured: Baseline/preoperative to postoperative day 14

  3. Analgesic consumption

    Opioid consumption: record rescue analgesic use

    Measured: Baseline/preoperative to postoperative day 14

  4. Quadriceps strength via handheld dynamometry.

    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.

    Measured: Baseline/preoperative to postoperative day 14

  5. Neuromuscular electrical stimulation response

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

    Measured: Baseline/preoperative to postoperative day 14

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

    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.

    Measured: postoperative day 14

  7. Serum Interleukin-6 (IL-6)

    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)

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

  8. Hemostasis or clotting tests

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

    Measured: Baseline/preoperative to postoperative day 14

  9. Serum C-Reactive Protein (CRP)

    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)

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

  10. Serum Interleukin-10 (IL-10)

    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)

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

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

    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)

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

  12. Prothrombin Time (PT)

    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)

    Measured: Baseline (preoperative) and postoperative day 14.

  13. Activated Partial Thromboplastin Time (APTT)

    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

    Measured: Baseline (preoperative) and postoperative day 14.

  14. D-dimer

    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)

    Measured: Frame: Baseline (preoperative) and postoperative day 14.

  15. Fibrinogen

    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)

    Measured: Baseline (preoperative) and postoperative day 14.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2026
  2. Study start16 Jun 2026 (estimated)
  3. Primary completionMay 2027 (estimated)
  4. Study completion16 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
68 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07688642
Sponsor's protocol ID
04-2026-30083
Status last verified
Mar 2026
First submitted
4 Jun 2026
Last updated
7 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Windisch C, Kolb W, Kolb K, Grutzner P, Venbrocks R, Anders J. Pneumatic compression with foot pumps facilitates early postoperative mobilisation in total knee arthroplasty. Int Orthop. 2011 Jul;35(7):995-1000. doi: 10.1007/s00264-010-1091-8. Epub 2010 Jul 22.

    PubMed 20652250
  • Li H, Zhang W, Lu Q, Wang J, Zhi Y, Zhang L, Zhou L. Which Frequency of Ankle Pump Exercise Should Be Chosen for the Prophylaxis of Deep Vein Thrombosis? Inquiry. 2022 Jan-Dec;59:469580221105989. doi: 10.1177/00469580221105989.

    PubMed 35658650
  • Lee B, Yoon D, Yim J. Effects of an Early Exercise Program with Cryotherapy on Range of Motion, Pain, Swelling, and Gait in Patients with Total Knee Arthroplasty: A Randomized Controlled Trial. J Clin Med. 2024 Feb 29;13(5):1420. doi: 10.3390/jcm13051420.

    PubMed 38592218
  • Carnevale Pellino V, Gatti A, Vandoni M, Patane P, Febbi M, Ballarin S, Cavallo C, Marin L. Pneumatic Compression Combined with Standard Treatment after Total Hip Arthroplasty and Its Effects on Edema of the Operated Limb and on Physical Outcomes: A Pilot Clinical Randomized Controlled Study. J Clin Med. 2023 Jun 20;12(12):4164. doi: 10.3390/jcm12124164.

    PubMed 37373857
  • Incesoy MA, Demirkiran CB, Kaya HB, Geckalan MA, Tak AY, Elmali N, Yildiz F, Uzer G. Natural course of postoperative C-reactive protein and erythrocyte sedimentation rate in unilateral and simultaneous bilateral total knee arthroplasty. BMC Musculoskelet Disord. 2025 Mar 14;26(1):260. doi: 10.1186/s12891-025-08523-0.

    PubMed 40087715
  • Si HB, Yang TM, Zeng Y, Zhou ZK, Pei FX, Lu YR, Cheng JQ, Shen B. Correlations between inflammatory cytokines, muscle damage markers and acute postoperative pain following primary total knee arthroplasty. BMC Musculoskelet Disord. 2017 Jun 17;18(1):265. doi: 10.1186/s12891-017-1597-y.

    PubMed 28623906
  • Londhe SB, Shah RV, Doshi AP, Londhe SS, Subhedar K. CRP (C Reactive Protein) level after total knee replacement in Indian population--- does it follow Anglo-Saxon trend? Arthroplasty. 2020 Aug 27;2(1):24. doi: 10.1186/s42836-020-00043-7.

    PubMed 35236472
  • Huang ZY, Huang Q, Wang LY, Lei YT, Xu H, Shen B, Pei FX. Normal trajectory of Interleukin-6 and C-reactive protein in the perioperative period of total knee arthroplasty under an enhanced recovery after surgery scenario. BMC Musculoskelet Disord. 2020 Apr 21;21(1):264. doi: 10.1186/s12891-020-03283-5.

    PubMed 32316949

Questions about this trial

What is this clinical trial studying?

A study testing standard postoperative TKR rehabilitation and Standard Rehabilitation Plus Circulatory Exercise in people with Total Knee Replacement and Knee Osteoarthritis, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07688642, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.

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