NCT07141316

Brief Summary

The goal of this clinical trial is to learn whether blood flow restriction (BFR) combined with electrostimulation (ES) can improve the postoperative course of patients undergoing total knee arthroplasty. The main questions it aims to answer are: Immediately after surgery, do BFR combined with ES increase quadriceps strength? Do they also improve the functional abilities of patients? Researchers will compare BFR combined with ES to ES alone, to see if there are differences. Participants will carry out a daily session of BFR+ ES or ES alone for six working days after surgery

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 10, 2025

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

August 4, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 26, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2026

Completed
Last Updated

August 26, 2025

Status Verified

August 1, 2025

Enrollment Period

9 months

First QC Date

August 4, 2025

Last Update Submit

August 25, 2025

Conditions

Osteo Arthritis Knee

Keywords

Blood Flow Restriction, Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Maximum quadriceps strength of the operated limb

    Maximum quadriceps strength, measured with a dynamometer and expressed in kilograms

    From the second to the tenth day post surgery.

Secondary Outcomes (3)

  • Functional Capacities

    From the second to the tenth day post surgery.

  • Functional Strength

    From the second to the tenth day post surgery.

  • Walking autonomy

    From the second to the tenth day post surgery.

Study Arms (2)

Blood flow restriction and Electrostimulation (GEL)

EXPERIMENTAL

For six working days, starting from the third day after surgery, he will perform 30 minutes of blood flow restriction once a day during electrostimulation of the quadriceps of the operated limb.

Device: Blood flow restriction combined with electrostimulation.

Electrostimulation alone (GST)

NO INTERVENTION

For six working days, starting from the third day after surgery, he will perform 30 minutes of electrostimulation of the quadriceps of the operated limb once a day

Interventions

Blood flow restriction combined with electrostimulation.DEVICE

Participants will perform 30 minutes of blood flow restriction once a day during electrostimulation of the quadriceps of the operated limb.

Blood flow restriction and Electrostimulation (GEL)

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective knee arthroplasty surgery

You may not qualify if:

  • obesity (body mass index equal to or greater than 30 Kg/m2);
  • concomitant orthopaedic or neurological pathologies (other than the pathology for which arthroprosthesis has been indicated) that modify walking capacity;
  • pathologies that modify the balance (neurological and/or vestibular);
  • contraindications to the use of medical equipment used in the practice;
  • inability to understand and sign informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto di Cura "Città di Pavia"

Pavia, 27100, Italy

Location

Related Publications (17)

  • Praetorius A. [Blood flow restriction training (BFRT) in patients before and after total knee arthroplasty]. Orthopadie (Heidelb). 2024 Nov;53(11):853-857. doi: 10.1007/s00132-024-04543-1. Epub 2024 Aug 9. German.

    PMID: 39120683RESULT

  • Conference Proceedings for the 10th Annual Meeting of Arthroplasty Society in Asia (ASIA), 26th Annual Meeting of the Thai Hip and Knee Society (THKS), and the 16th Annual Meeting of the ASEAN Arthroplasty Association (AAA). Arthroplasty. 2024 Dec 20;6(Suppl 1):62. doi: 10.1186/s42836-024-00286-8. No abstract available.

    PMID: 39702276RESULT

  • Wengle L, Migliorini F, Leroux T, Chahal J, Theodoropoulos J, Betsch M. The Effects of Blood Flow Restriction in Patients Undergoing Knee Surgery: A Systematic Review and Meta-analysis. Am J Sports Med. 2022 Aug;50(10):2824-2833. doi: 10.1177/03635465211027296. Epub 2021 Aug 18.

    PMID: 34406084RESULT

  • De Renty C, Forelli F, Mazeas J, Kakavas G, Hewett TE, Korakakis V. Knee Loading With Blood Flow Restriction Can Enhance Recovery After Total Knee Arthroplasty. Cureus. 2023 Apr 20;15(4):e37895. doi: 10.7759/cureus.37895. eCollection 2023 Apr.

    PMID: 37214015RESULT

  • Zhang T, Wang X, Wang J. Effect of blood flow restriction combined with low-intensity training on the lower limbs muscle strength and function in older adults: A meta-analysis. Exp Gerontol. 2022 Jul;164:111827. doi: 10.1016/j.exger.2022.111827. Epub 2022 May 1.

    PMID: 35508279RESULT

  • Chang H, Yao M, Chen B, Qi Y, Zhang J. Effects of Blood Flow Restriction Combined with Low-Intensity Resistance Training on Lower-Limb Muscle Strength and Mass in Post-Middle-Aged Adults: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2022 Nov 25;19(23):15691. doi: 10.3390/ijerph192315691.

    PMID: 36497769RESULT

  • Das A, Paton B. Is There a Minimum Effective Dose for Vascular Occlusion During Blood Flow Restriction Training? Front Physiol. 2022 Apr 8;13:838115. doi: 10.3389/fphys.2022.838115. eCollection 2022.

    PMID: 35464074RESULT

  • Freitas EDS, Miller RM, Heishman AD, Ferreira-Junior JB, Araujo JP, Bemben MG. Acute Physiological Responses to Resistance Exercise With Continuous Versus Intermittent Blood Flow Restriction: A Randomized Controlled Trial. Front Physiol. 2020 Mar 17;11:132. doi: 10.3389/fphys.2020.00132. eCollection 2020.

    PMID: 32256374RESULT

  • Barber-Westin S, Noyes FR. Blood Flow-Restricted Training for Lower Extremity Muscle Weakness due to Knee Pathology: A Systematic Review. Sports Health. 2019 Jan/Feb;11(1):69-83. doi: 10.1177/1941738118811337. Epub 2018 Nov 26.

    PMID: 30475660RESULT

  • Loenneke JP, Abe T, Wilson JM, Thiebaud RS, Fahs CA, Rossow LM, Bemben MG. Blood flow restriction: an evidence based progressive model (Review). Acta Physiol Hung. 2012 Sep;99(3):235-50. doi: 10.1556/APhysiol.99.2012.3.1.

    PMID: 22982712RESULT

  • Bielitzki R, Behrendt T, Behrens M, Schega L. Time to Save Time: Beneficial Effects of Blood Flow Restriction Training and the Need to Quantify the Time Potentially Saved by Its Application During Musculoskeletal Rehabilitation. Phys Ther. 2021 Oct 1;101(10):pzab172. doi: 10.1093/ptj/pzab172.

    PMID: 34228788RESULT

  • Scott BR, Loenneke JP, Slattery KM, Dascombe BJ. Exercise with blood flow restriction: an updated evidence-based approach for enhanced muscular development. Sports Med. 2015 Mar;45(3):313-25. doi: 10.1007/s40279-014-0288-1.

    PMID: 25430600RESULT

  • A. K. Sandilya, D. Kashyap, A. Arunmozhi, M. Wadhwa, e V. Verma, "The importance of Blood Flow Restriction Training (BFRT) in Physiotherapy: A Review of Literature", J. Reatt. Ther. Dev. Divers., ago. 2023, doi: 10.53555/jrtdd.v6i8s.2643.

    RESULT

  • Katz JN, Arant KR, Loeser RF. Diagnosis and Treatment of Hip and Knee Osteoarthritis: A Review. JAMA. 2021 Feb 9;325(6):568-578. doi: 10.1001/jama.2020.22171.

    PMID: 33560326RESULT

  • Xia B, Di Chen, Zhang J, Hu S, Jin H, Tong P. Osteoarthritis pathogenesis: a review of molecular mechanisms. Calcif Tissue Int. 2014 Dec;95(6):495-505. doi: 10.1007/s00223-014-9917-9. Epub 2014 Oct 14.

    PMID: 25311420RESULT

  • Litwic A, Edwards MH, Dennison EM, Cooper C. Epidemiology and burden of osteoarthritis. Br Med Bull. 2013;105:185-99. doi: 10.1093/bmb/lds038. Epub 2013 Jan 20.

    PMID: 23337796RESULT

  • Michael JW, Schluter-Brust KU, Eysel P. The epidemiology, etiology, diagnosis, and treatment of osteoarthritis of the knee. Dtsch Arztebl Int. 2010 Mar;107(9):152-62. doi: 10.3238/arztebl.2010.0152. Epub 2010 Mar 5.

    PMID: 20305774RESULT

Study Officials

  • luca Marin, PhD

    University of Pavia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2025

First Posted

August 26, 2025

Study Start

July 10, 2025

Primary Completion

April 10, 2026

Study Completion

April 10, 2026

Last Updated

August 26, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

On justified request and in anonymised form.

Shared Documents
ANALYTIC CODE
Time Frame
From the publication of the study (start date) for five years (end date).
Access Criteria
Only researchers who request it for a justified reason will be able to access the data in anonymized form

Locations

IT(1)