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| Name | Class |
|---|---|
| Nazarbayev University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
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| 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:
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|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bilal Khan, Master's | Rehman Medical Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rehman Medical Institute | Peshawar | KPK | 24630 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25430600 | Background | 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. | |
| 26920430 | 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. |
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IPD will be share during and after the study completion with other researchers.
Within a 1-year timeframe, the study will share all required documents and SAPs with other researchers.
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There were no excluded participants of enrolled groups during data collection.
Medical hospital
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| ID | Title | Description |
|---|---|---|
| FG000 | Non-Blood Flow Restriction Band | 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:
Blood Flow Restriction band: 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. |
| FG001 | Blood Flow Restriction Band | 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:
Blood Flow Restriction band: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Data were analyzed by checking the normality of data. Sample T test and Mann Whitney U test were used for two groups
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| ID | Title | Description |
|---|---|---|
| BG000 | Non-Blood Flow Restriction Band | 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:
Blood Flow Restriction band: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Range of Motion | Knee range of motion assessed weekly for eight consecutive weeks with the patient in a supine position using goniometer. | Posted | Mean | Standard Deviation | Degrees | eight weeks |
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Adverse effects were not assessed.
Adverse effects were not monitored.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Blood Flow Restriction Band | Adverse effects were not assessed | 0 |
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Sample size was small
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Iftikhar qayum | Rehman Medical Institute | +92 91 5838 333 | 4708 | iftikhar.qayum@rmi.edu.pk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 1, 2025 | Aug 2, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006833 | Hydrarthrosis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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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.
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Single-assessor blinded
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| 36415269 | 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. |
| BG001 | Blood Flow Restriction Band | 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:
Blood Flow Restriction band: 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Non-Blood Flow Restriction Band | 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:
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | eight weeks |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | eight weeks |
|
|
|
| Primary | Quadricep Size | Muscle size assessed using measuring tap wrapping around the thigh of pre-patellar region. | Posted | Mean | Standard Deviation | cm | eight weeks |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Non-Blood Flow Restriction Band | Adverse effects were not assessed | 0 | 0 | 0 | 0 | 0 | 0 |
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