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

Not Applicable

Completed

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

• Registration Number: NCT06480032
• Lead Sponsor: Abasyn University Peshawar

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.

Detailed Description

The purpose of this randomized controlled trial is to compare the effectiveness of low-load blood flow restriction training (BFR-RT) with low-load traditional resistance training exercises (T-RT) in individuals who have undergone anterior cruciate ligament reconstruction (ACLR) surgery. The anterior cruciate ligament is a major knee ligament that provides stability to the knee joint. ACL injuries are common, and surgical reconstruction is often necessary to restore knee stability and function.

The study was conducted at Rehman Medical Institute over approximately one and a half years. The sample size consists of 32 participants who meet the inclusion criteria, including having undergone unilateral ACLR surgery within the past 8 weeks and being free of any neurological impairments or significant cardiac, pulmonary, or metabolic conditions.

Participants were randomly assigned to either the BFR-RT or T-RT group using a random sampling technique. Randomization was conducted by an independent member of the research team using opaque envelopes containing coded group assignments to ensure unbiased allocation.

The intervention involved 8 weeks of biweekly unilateral leg training on the affected limb under the instruction of a physiotherapist, totaling 16 training sessions. Participants in both groups received the standard rehabilitation program provided by the hospital. In the BFR-RT group, blood flow restriction was achieved using an occlusion band placed on the most proximal portion of the affected limb. The physical therapist ensured the band was not too tight, allowing one finger to pass through the band.

Data were collected at three time points: post-surgery (week 0-1), mid-training (week 4-5), and post-training (week 9). Outcomes measured included skeletal muscle hypertrophy, strength (assessed using manual muscle testing), range of motion (ROM) of the knee joint, pain (assessed using a Knee Injury and Osteoarthritis Outcome Score), and effusion (measured by knee joint circumference). Adherence rates, exercise session attendance, and no adverse events were recorded.

Study Timeline

• Study Start: 2023-06-04
• Study First Submitted: 2024-04-15
• Primary Completion: 2024-06-17
• Study First Submitted QC: 2024-06-24
• Study First Posted: 2024-06-28
• Study Completion: 2024-08-02
• Results First Submitted: 2024-11-02
• Status Verified: 2025-08
• Results First Submitted QC: 2025-08-02
• Last Update Submitted: 2025-08-02
• Results First Posted: 2025-08-15
• Last Update Posted: 2025-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Range of Motion	eight weeks	Knee range of motion assessed weekly for eight consecutive weeks with the patient in a supine position using goniometer.
Quadricep Strength	eight weeks	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.
Knee Pain	eight weeks	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.
Quadricep Size	eight weeks	Muscle size assessed using measuring tap wrapping around the thigh of pre-patellar region.

Trial Locations

Locations (1)

Rehman Medical Institute; 🇵🇰 Peshawar, KPK, Pakistan