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

Abasyn University Peshawar

Status: Completed

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

Treatments: Device: Blood Flow Restriction band

Study type: Interventional

Funder types: Other

Identifiers

NCT06480032

AbasynU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups

Blood Flow Restriction band

Experimental group

Description:

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.

Treatment:

Device: Blood Flow Restriction band

Non-Blood Flow Restriction band

Other group

Description:

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.

Treatment:

Device: Blood Flow Restriction band