NCT07384780

Brief Summary

The goal of this clinical trial is to see which type of strengthening exercise with a tight band (blood flow restriction) helps people recover better after ACL reconstruction. The study includes adults after ACL surgery who are doing physiotherapy to rebuild thigh muscle strength and knee function. The main questions are:

  • Does heavy strengthening with blood flow restriction improve thigh strength, knee function, and daily activities more than light strengthening with blood flow restriction after ACL surgery?
  • Can light strengthening with blood flow restriction give similar benefits to heavy strengthening while putting less strain on the knee? Researchers will compare a heavy-exercise program plus blood flow restriction to a light-exercise program plus blood flow restriction to see which gives better strength and functional improvements. Participants will:
  • Come for supervised physiotherapy sessions and do knee exercises on a machine, using either heavy or light loads while a cuff on the thigh gently squeezes to reduce blood flow.
  • Have their leg strength, and knee questionnaires checked several times during the study.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Feb 2026

Shorter than P25 for not_applicable

Status
not yet 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 Progress80%
Feb 2026Jun 2026

First Submitted

Initial submission to the registry

January 27, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

February 5, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

January 27, 2026

Last Update Submit

February 3, 2026

Conditions

Keywords

blood flow restriction training ACLBlood flow restrictionACL RehabACLRACL ReconstructionBFR therapy anterior cruciate ligament reconstructionBFR therapy ACLRBFR Therapylow-load versus high-load BFR knee rehabilitationisokinetic strength training after ACL surgeryphysiotherapy rehabilitation protocol ACL isokinetic BFRKnee physiotherapyACLACL IsokineticACLٍ Isokinetic

Outcome Measures

Primary Outcomes (2)

  • Muscle Strength

    Muscle strength will be measured using Biodex System 4 Pro for concentric quadriceps and hamstring strength at 60°/s and eccentric quadriceps at 60°/s. Recorded parameters: peak torque(Nm/kg), total work(J), and average power(W).

    Outcome measures will be measured at baseline(week 0), mid-intervention(week 3) and post-intervention(week 6)

  • Muscle Girth

    Muscle girth will be measured by measuring the mid-thigh circumference using an inch tape at 15cm above the superior border of the patella. The mean of two readings will be recorded

    Outcome measures will be measured at baseline(week 0), mid-intervention(week 3) and post-intervention(week 6)

Secondary Outcomes (3)

  • Pain Reduction

    Outcome measures will be measured at baseline(week 0), mid-intervention(week 3) and post-intervention(week 6)

  • Blood Flow

    Outcome measures will be measured at baseline(week 0), mid-intervention(week 3) and post-intervention(week 6)

  • Tolerability and Perception of the Intervention(s)

    Outcome measures will be measured at baseline(week 0), mid-intervention(week 3) and post-intervention(week 6)

Study Arms (2)

ACL Reconstruction Population

ACTIVE COMPARATOR
Other: High Load Isokinetic Training with Blood Flow RestrictionOther: Low Load Isokinetic Training with Blood Flow Restriction

Healthy Population

ACTIVE COMPARATOR
Other: High Load Isokinetic Training with Blood Flow RestrictionOther: Low Load Isokinetic Training with Blood Flow Restriction

Interventions

Low Load strength training that was administered through the use of an isokinetic device, and not conventional strength training equipment, combined with blood flow restriction.

Also known as: Low Load strength training, Low Load Isokinetic training, Blood Flow Restriction, BFR
ACL Reconstruction PopulationHealthy Population

High Load strength training that was administered through the use of an isokinetic device, and not conventional strength training equipment, combined with blood flow restriction.

Also known as: High Load strength training, High Load Isokinetic training, Blood Flow Restriction, BFR
ACL Reconstruction PopulationHealthy Population

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • For ACLR group:
  • Isolated unilateral ACL reconstruction 8-16 weeks post-surgery with medical clearance for moderate to high resistance training.
  • For control group(healthy population):
  • Healthy adults with no musculoskeletal pathology.

You may not qualify if:

  • History of cardiovascular or metabolic diseases
  • Deep vein thrombosis
  • Coagulopathy
  • Hypertension
  • Skin lesions or infections at the site of BFR cuff administration
  • Neuromuscular disorders
  • Non-clearance from the surgeon or physiotherapist or resistance training.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (27)

  • Reid D. Predicting maximal strength of quadriceps from submaximal performance in individuals with knee joint osteoarthritis. Arthritis Care & Research. 2011; doi:10.1002/ACR.20368

    BACKGROUND
  • de Deus Passos M, da Rocha AF. Evaluation of infrared thermography with a portable camera as a diagnostic tool for peripheral arterial disease of the lower limbs compared with color Doppler ultrasonography. Arch Med Sci Atheroscler Dis. 2022 Aug 8;7:e66-e72

    BACKGROUND
  • Côrte AC, Pedrinelli A, Marttos A, Souza IFG, Grava J, José Hernandez A. Infrared thermography study as a complementary method of screening and prevention of muscle injuries: pilot study. BMJ Open Sport & Exercise Medicine. 2019

    BACKGROUND
  • Alghadir AH, Anwer S, Iqbal A, Iqbal ZA. Test-retest reliability, validity, and minimum detectable change of visual analog, numerical rating, and verbal rating scales for measurement of osteoarthritic knee pain. J Pain Res. 2018 Apr 26;11:851-856

    BACKGROUND
  • Cvjetkovic DD, Bijeljac S, Palija S, Talic G, Radulovic TN, Kosanovic MG, Manojlovic S. Isokinetic Testing in Evaluation Rehabilitation Outcome After ACL Reconstruction. Med Arch. 2015 Feb;69(1):21-3. doi: 10.5455/medarh.2015.69.21-23

    BACKGROUND
  • Gopinatth V, Garcia JR, Reid IK, Knapik DM, Verma NN, Chahla J. Blood Flow Restriction Enhances Recovery After Anterior Cruciate Ligament Reconstruction: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Arthroscopy. 2025 Apr;41(4):1048-1060

    BACKGROUND
  • Lin Q, Zhang Y, Qin J, Wu F. Effects of Low-Load Blood Flow Restriction Training on Muscle Volume After Anterior Cruciate Ligament Reconstruction: A Systematic Review and Meta-analysis. Orthop J Sports Med. 2024 Dec 13;12(12):23259671241301731

    BACKGROUND
  • Koc B, Jansen E, de Jong O, et al. Qualitative Evaluation of Patient Experiences with Low-Load Blood Flow Restriction and Heavy-Load Resistance Training Post-ACL Reconstruction. IJSPT. 2025;20(10):1479-1488

    BACKGROUND
  • Koc BB, Truyens A, Heymans MJLF, Jansen EJP, Schotanus MGM. Effect of Low-Load Blood Flow Restriction Training After Anterior Cruciate Ligament Reconstruction: A Systematic Review. Int J Sports Phys Ther. 2022 Apr 1;17(3):334-346

    BACKGROUND
  • Moletta C, Kuenze CM, Morgan K, Coiner DR, Jacobson TA, Schmitz KH, Zajac NN, Boumerhi JS, Grindstaff TL. Hamstrings volumetric adaptations to a four-week Nordic hamstring exercise protocol in individuals with ACL reconstruction: a preliminary case series. Int J Sports Phys Ther. 2025 Sep 1;20(5):801-814

    BACKGROUND
  • Mengis N, Höher J, Ellermann A, Eberle C, Hartner C, Keller M, Rippke JN, Sprenger N, Stein T, Stoffels T, Egloff C, Niederer D. A Guideline for Validated Return-to-Sport Testing in Everyday Clinical Practice: A Focused Review on the Validity, Reliability, and Feasibility of Tests Estimating the Risk of Reinjury After ACL Reconstruction. Orthop J Sports Med. 2025 May 5;13(5):23259671251317208

    BACKGROUND
  • Hiemstra LA, Webber S, MacDonald PB, Kriellaars DJ. Contralateral limb strength deficits after anterior cruciate ligament reconstruction using a hamstring tendon graft. Clin Biomech (Bristol). 2007 Jun;22(5):543-50

    BACKGROUND
  • Kuenze C, Hart JM. Quadriceps strength thresholds and patient-reported function after anterior cruciate ligament reconstruction: a systematic review. J Sport Rehabil. 2023 Jun 1;32(5):458-468. doi: 10.1123/jsr.2022-0362

    BACKGROUND
  • Schwery NA, Kiely MT, Larson CM, Wulf CA, Heikes CS, Hess RW, Giveans MR, Solie BS, Doney CP. Quadriceps strength following anterior cruciate ligament reconstruction: normative values based on sex, graft type and meniscal status at 3, 6 & 9 months. Int J Sports Phys Ther. 2022 Apr 1;17(3):434-444

    BACKGROUND
  • Liao LR, Ng GYF, Jones AY, Lee LK, Leung HK, Ng SSM. Predicting maximal strength of quadriceps from submaximal performance in individuals with knee joint osteoarthritis. J Orthop Sports Phys Ther. 2015;45(5):408-414

    BACKGROUND
  • Nascimento DCN, Rolnick N, Sousa Neto IV, Severin R, Beal FLR. A useful blood flow restriction training risk stratification for exercise and rehabilitation. Front Physiol. 2022 Mar 11;13:808622

    BACKGROUND
  • Welsh JJ, Robinson DM, Dankel SJ. A systematic review examining blood flow restriction in combination with isokinetic resistance exercise. J Trainology. 2024;13(1):3-11

    BACKGROUND
  • Hughes L, Patterson SD, Haddad F, Rosenblatt B, Gissane C, McCarthy D, Clarke T, Ferris G, Dawes J, Paton B. Examination of the comfort and pain experienced with blood flow restriction training during post-surgery rehabilitation of anterior cruciate ligament reconstruction patients: A UK National Health Service trial. Phys Ther Sport. 2019 Sep;39:90-98

    BACKGROUND
  • Rolnick N, Kimbrell K, Cerqueira MS, Weatherford B, Brandner C. Perceived barriers to blood flow restriction training. Front Rehabil Sci. 2021 Jul 8;2:697082

    BACKGROUND
  • Farooq U, Cheema MY, Imran M, Gulzar M. Acute and chronic blood flow restriction resistance training: mechanisms and applications in sports. J Exerc Sci Fit. 2025;23(2):279-288

    BACKGROUND
  • Büyüklüoğlu G, Akinoğlu B, Günaydin H, Küçük İ, Örsçelik A, Kocahan T. Isokinetic exercise combined with blood flow restriction (BFR) may produce a greater change in the angle of peak torque. Med Sport. 2025;78(1):18-22

    BACKGROUND
  • Kubosch EJ, Izadi M, Wawrzyniak N, Hedtmann K, Pässler V, Rolvien T, von der Heide D, Lutter C, Fehér D, Engelhardt M. Blood flow restriction training for hamstring muscle strength after anterior cruciate ligament reconstruction: a randomized controlled trial. Knee. 2024 Aug;41:2444-2452

    BACKGROUND
  • Kwon S, Bae KC, Yon CJ, Kim DH. Current narrative review-application of blood flow restriction exercise in clinical knee problems. Medicina (Kaunas). 2025 Jul 30;61(8):1377

    BACKGROUND
  • Su C, Zhang Z, Liang B, Zhou S, Long X. Effects of blood flow restriction combined with high-load training on muscle strength and sports performance in athletes: a systematic review and meta-analysis. Front Physiol. 2025;16:1603568

    BACKGROUND
  • Piskin NE, Aktug ZB, Kara M, Yavuz G, Ozturk GT, Ibis S, Aka H. The effect of blood flow restriction training on isokinetic strength, muscle thickness and athletic performance. J Musculoskelet Neuronal Interact. 2025;25(2):208-218

    BACKGROUND
  • Chang H, Yan J, Lu G, Chen B, Zhang J. Muscle strength adaptation between high-load resistance training versus low-load blood flow restriction training with different cuff pressure characteristics: a systematic review and meta-analysis. Front Physiol. 2023 Aug 25;14:1244292

    BACKGROUND
  • Colombo V, Valenčič T, Steiner K, Škarabot J, Folland J, O'Sullivan O, Kluzek S. Comparison of blood flow restriction interventions to standard rehabilitation after an anterior cruciate ligament injury: a systematic review. Am J Sports Med. 2024 Apr 9;52(14):3641-3650

    BACKGROUND

MeSH Terms

Interventions

Blood Flow Restriction Therapy

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Central Study Contacts

Osman Z Khan, Bachelors of Physiotherapy

CONTACT

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

January 27, 2026

First Posted

February 3, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

February 5, 2026

Record last verified: 2026-02