Circulatory Exercise After Total Knee Replacement

Official title

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

Overview

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.

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.

Interventions

• Other standard postoperative TKR rehabilitation
  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.
• Other Standard Rehabilitation Plus Circulatory Exercise
  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 outcome measures

• 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]

Secondary outcome measures (12)

• 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]
• Functional mobility: [Time frame: Baseline/preoperative to postoperative day 14]
• Analgesic consumption [Time frame: Baseline/preoperative to postoperative day 14]
• Quadriceps strength via handheld dynamometry. [Time frame: Baseline/preoperative to postoperative day 14]
• Neuromuscular electrical stimulation response [Time frame: Baseline/preoperative to postoperative day 14]
• Patient satisfaction with postoperative recovery measured by a 5-point Likert Scale [Time frame: postoperative day 14]
• 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.]
• Hemostasis or clotting tests [Time frame: Baseline/preoperative to postoperative day 14]
• Serum C-Reactive Protein (CRP) [Time frame: Baseline (preoperative), postoperative 24-48 hours, and postoperative day 14.]
• Serum Interleukin-10 (IL-10) [Time frame: Baseline (preoperative), postoperative 24-48 hours, and postoperative day 14.]
• Serum Tumor Necrosis Factor-alpha (TNF-α) [Time frame: Baseline (preoperative), postoperative 24-48 hours, and postoperative day 14.]
• Prothrombin Time (PT) [Time frame: Baseline (preoperative) and postoperative day 14.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 32316949

Identifiers

NCT: NCT07688642 · 04-2026-30083

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗