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Completed

NCT Number: NCT06480032

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rehman Medical Institute

Peshawar, KPK, 24630, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Brand name: Fitbiz Exercise Equipment

Primary outcomes

  1. Range of Motion

    Time frame: eight weeks

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

  2. Quadricep Strength

    Time frame: 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.

  3. Knee Pain

    Time frame: 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.

  4. Quadricep Size

    Time frame: eight weeks

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

Sponsors and collaborators

Lead sponsor

Abasyn University Peshawar

Other

Collaborators

  • Nazarbayev University

Registry information

Official study title

Low-Load Blood Flow Restriction Training vs Traditional Resistance Training Exercises Following Anterior Cruciate Ligament Reconstruction Surgery: A Pilot Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 28, 2024
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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