Circulatory Exercise After Total Knee Replacement

NCT07688642 | Not Yet Recruiting

• 1 other identifier: 04-2026-30083
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Total Knee Replacement; Knee Osteoarthritis; Postoperative Edema; Postoperative Inflammation

Keywords

Total knee arthroplasty; Total knee replacement; Circulatory exercise; Venous return; Ankle pump exercise; Postoperative edema; Postoperative inflammation; Rehabilitation

Outcome Measures

Primary Outcomes (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.

  Baseline/preoperative to postoperative day 14

Secondary Outcomes (15)

• 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

• Quadriceps strength via handheld dynamometry.

  Baseline/preoperative to postoperative day 14

• Neuromuscular electrical stimulation response

  Baseline/preoperative to postoperative day 14

Study Arms (2)

standard postoperative TKR rehabilitation (hospital protocol)

ACTIVE COMPARATOR

Other: standard postoperative TKR rehabilitation

Circulatory Exercise Protocol (in addition to standard rehab)

EXPERIMENTAL

Other: Standard Rehabilitation Plus Circulatory Exercise

Interventions

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 postoperative TKR rehabilitation (hospital protocol)

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.

Circulatory Exercise Protocol (in addition to standard rehab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (8)

• 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.

  PMID: 20652250 BACKGROUND

• 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.

  PMID: 35658650 BACKGROUND

• 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.

  PMID: 38592218 BACKGROUND

• 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.

  PMID: 37373857 BACKGROUND

• 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.

  PMID: 40087715 BACKGROUND

• 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.

  PMID: 28623906 BACKGROUND

• 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.

  PMID: 35236472 BACKGROUND

• 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.

  PMID: 32316949 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist, PhD

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: July 7, 2026
• Study Start: June 16, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 16, 2027
• Last Updated: July 7, 2026

Record last verified: 2026-03