Effusion Joint, Pain-Knee, Range of Motion, Skeletal Muscle Hypertrophy, Strength
Conditions
Keywords
Blood Flow Restriction Training, Resistance Training, Anterior Cruciate Ligament Reconstruction, Skeletal Muscle Hypertrophy
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.
Interventions
DEVICEBlood 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.
Sponsors
Nazarbayev University
Abasyn University Peshawar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Single-assessor blinded
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Pakistan
Participant flow
Recruitment details
Medical hospital
Pre-assignment details
There were no excluded participants of enrolled groups during data collection.
Participants by arm
| Arm | Count |
|---|---|
| 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:
* 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.
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. | 16 |
| 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:
* 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.
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. | 16 |
| Total | 32 |
Baseline characteristics
| Characteristic | Blood Flow Restriction Band | Total | Non-Blood Flow Restriction Band |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 32 Participants | 16 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Pakistan | 16 participants | 32 Participants | 16 participants |
| Sex: Female, Male Female | 2 Participants | 7 Participants | 5 Participants |
| Sex: Female, Male Male | 14 Participants | 25 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: eight weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blood Flow Restriction Band | Knee Pain | 2.0625 units on a scale | Standard Deviation 1.12361 |
| Non-Blood Flow Restriction Band | Knee Pain | 1.9375 units on a scale | Standard Deviation 1.340087 |
Primary
Quadricep Size
Muscle size assessed using measuring tap wrapping around the thigh of pre-patellar region.
Time frame: eight weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blood Flow Restriction Band | Quadricep Size | 19.375 cm | Standard Deviation 2.028957 |
| Non-Blood Flow Restriction Band | Quadricep Size | 18.65625 cm | Standard Deviation 2.650275 |
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.
Time frame: eight weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blood Flow Restriction Band | Quadricep Strength | 3.9375 units on a scale | Standard Deviation 3.5 |
| Non-Blood Flow Restriction Band | Quadricep Strength | .6800735 units on a scale | Standard Deviation 0.5163978 |
Primary
Range of Motion
Knee range of motion assessed weekly for eight consecutive weeks with the patient in a supine position using goniometer.
Time frame: eight weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blood Flow Restriction Band | Range of Motion | 74.0625 Degrees | Standard Deviation 14.04976 |
| Non-Blood Flow Restriction Band | Range of Motion | 80.3125 Degrees | Standard Deviation 14.65933 |