Low-Load Blood Flow Restriction Training vs Traditional Resistance Training Exercises Following ACLR Surgery

NCT06480032 | Completed Results DMC

• 1 other identifier: AbasynU
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective/s of the study is to compare the effectiveness of low load blood flow restriction training (LL-BFR) with traditional resistance training exercises (T-RT) at improving skeletal muscle hypertrophy, strength, Range of motion (ROM), pain and effusion in individuals who have undergone anterior cruciate ligament (ACL) reconstruction surgery. The study involves 32 participants who meet the inclusion criteria and randomly assign to either BFR-RT group or the T-RT group. The primary outcomes measured includes skeletal muscle hypertrophy, strength, range of motion, pain, and effusion. The intervention last for eight weeks, during which participants undergone resistance training according to their assigned group. Data collected at various time points, including post-surgery, mid-training, and post-training, to assess the effectiveness of the two training methods. The findings from this study are effective for anterior cruciate ligament reconstruction surgery (ACLR) patients in early rehabilitation and improve outcomes for individuals recovering from ACL injuries.

Conditions

Strength; Range of Motion; Pain-Knee; Skeletal Muscle Hypertrophy; Effusion Joint

Keywords

Blood Flow Restriction Training; Resistance Training; Anterior Cruciate Ligament Reconstruction; Skeletal Muscle Hypertrophy

Outcome Measures

Primary Outcomes (4)

• Range of Motion

  Knee range of motion assessed weekly for eight consecutive weeks with the patient in a supine position using goniometer.

  eight weeks

• Quadricep Strength

  Strength assessed through manual muscle testing (MMT). The grading scale ranges from 0 to 5, with Grade 0 indicating no visible or palpable muscle contraction and Grade 5 indicates muscle movement against gravity and maximal resistance.

  eight weeks

• Knee Pain

  Pain was assessed using visual analogue scale. This questionnaire ranges 0 to 10, where 10 indicates the worst pain and 0 indicates no pain. A higher score reflects higher pain.

  eight weeks

• Quadricep Size

  Muscle size assessed using measuring tap wrapping around the thigh of pre-patellar region.

  eight weeks

Study Arms (2)

Blood Flow Restriction band

EXPERIMENTAL

Group 1, comprising 16 patients (Group 1), undergo the standard Anterior Cruciate Ligament (ACL) rehabilitation protocol with Blood Flow Restriction (BFR) for 8 weeks during their physiotherapy sessions at the Rehman Medical Institute's Outpatient Department (OPD), starting from the second post-operative visit. The cuff size determined based on the patient's thigh circumference. The rehabilitation protocol will progress as follows: * Week 2-4: Long Arc Quadriceps (LAQ) exercise progression, Shuttle exercise progression, and Post-op visit 2. * Week 4-8: Available range LAQ, Standing terminal knee extension, and Single Limb Shuttle/Leg Press exercises.

Device: Blood Flow Restriction band

Non-Blood Flow Restriction band

OTHER

Group B, comprising 16 patients (Group 2), undergo the standard Anterior Cruciate Ligament (ACL) rehabilitation protocol without Blood Flow Restriction (BFR) for 8 weeks during their physiotherapy sessions at the Rehman Medical Institute's Outpatient Department (OPD), starting from the second post-operative visit. The cuff size determined based on the patient's thigh circumference. The rehabilitation protocol will progress as follows: * Week 2-4: Long Arc Quadriceps (LAQ) exercise progression, Shuttle exercise progression, and Post-op visit 2. * Week 4-8: Available range LAQ, Standing terminal knee extension, and Single Limb Shuttle/Leg Press exercises.

Device: Blood Flow Restriction band

Interventions

Blood Flow Restriction band DEVICE

Blood Flow Restriction (BFR) band operate by partially occluding arterial blood flow to distal structures, but more significantly impeding venous outflow from under the cuff, thereby also hindering venous return. The compression of vasculature proximal to the skeletal muscle leads to inadequate oxygen supply (hypoxia) within the muscle tissue, resulting in a localized hypoxic environment. Additionally, the reduction in venous blood flow causes blood to accumulate in the capillaries of the occluded limb, often manifesting as visible erythema. This temporary restriction will be maintained for a duration of 8 weeks.

Also known as: Brand name: Fitbiz Exercise Equipment

Blood Flow Restriction band; Non-Blood Flow Restriction band

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Post-ACL reconstruction surgery (week 0-8)
• Both male and female
• No known history of central or peripheral neurological impairment
• Free of any cardiac, pulmonary or metabolic conditions
• Willing to participate

You may not qualify if:

• History of deep vein thrombosis or vascular pathology in any lower limb
• Intraarticular injections into the knee in the preceding 6 months
• Rheumatoid arthritis or other significant co-morbidities
• Use of anticoagulant medications

Sponsors & Collaborators

• Abasyn University Peshawar: lead
• Nazarbayev University: collaborator

Study Sites (1)

Rehman Medical Institute

Peshawar, KPK, 24630, Pakistan

Location

Related Publications (3)

• 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: 25430600 BACKGROUND

• Sanders TL, Maradit Kremers H, Bryan AJ, Larson DR, Dahm DL, Levy BA, Stuart MJ, Krych AJ. Incidence of Anterior Cruciate Ligament Tears and Reconstruction: A 21-Year Population-Based Study. Am J Sports Med. 2016 Jun;44(6):1502-7. doi: 10.1177/0363546516629944. Epub 2016 Feb 26.

  PMID: 26920430 BACKGROUND

• Khalid K, Anwar N, Saqulain G, Afzal MF. Neuromuscular Training following Anterior Cruciate Ligament reconstruction - Pain, Function, Strength, Power & Quality of Life Perspective: A Randomized Control Trial. Pak J Med Sci. 2022 Nov-Dec;38(8):2175-2181. doi: 10.12669/pjms.38.8.5730.

  PMID: 36415269 BACKGROUND

MeSH Terms

Conditions

Hydrarthrosis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Limitations and Caveats

Sample size was small

Results Point of Contact

• Title: Dr.Iftikhar qayum
• Organization: Rehman Medical Institute

iftikhar.qayum@rmi.edu.pk

+92 91 5838 333

Study Officials

• Bilal Khan, Master's

  Rehman Medical Institute

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Single-assessor blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: BFR with standard post-operative rehabilitation for 8 weeks followed by the standard protocol progression for the remainder of the treatment program. The other group (Group 2) receive standard post-operative rehabilitation without BFR for the duration of treatment program.

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: June 28, 2024
• Study Start: June 4, 2023
• Primary Completion: June 17, 2024
• Study Completion: August 2, 2024
• Last Updated: August 15, 2025
• Results First Posted: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Within a 1-year timeframe, the study will share all required documents and SAPs with other researchers.
• Access Criteria: PDF

Locations

PA (1)