Clinical trial NCT06480032: Low-Load Blood Flow Restriction Training vs Traditional Resistance Training Exercises Following ACLR Surgery
Official title: Low-Load Blood Flow Restriction Training vs Traditional Resistance Training Exercises Following Anterior Cruciate Ligament Reconstruction Surgery: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Strength
Range of Motion
Pain-Knee
Skeletal Muscle Hypertrophy
Effusion Joint
Keywords: Blood Flow Restriction Training
Resistance Training
Anterior Cruciate Ligament Reconstruction
Skeletal Muscle Hypertrophy
Lead sponsor: Abasyn University Peshawar
Sponsor class: OTHER
Collaborators: name: Rehman Medical Institute
First posted: 2024-06-28
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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) will receive standard post-operative rehabilitation without BFR for the duration of treatment program.
Primary purpose: TREATMENT

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, ROM, pain and effusion in individuals who have undergone anterior cruciate ligament (ACL) reconstruction surgery.

The study will involve 32 participants who meet the inclusion criteria and will be randomly assigned to either the BFR-RT group or the T-RT group. The primary outcomes measured will include skeletal muscle hypertrophy, strength, range of motion, pain, and effusion.

The intervention will last for eight weeks, during which participants will undergo resistance training according to their assigned group. Data will be 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 may help inform rehabilitation protocols 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 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 will be conducted at Rehman Medical Institute over approximately one and a half years. The sample size will consist 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 will be randomly assigned to either the BFR-RT group using a random sampling technique. Randomization will be conducted by an independent member of the research team using opaque envelopes containing coded group assignments to ensure unbiased allocation.

The intervention will involve 8 weeks of biweekly unilateral leg press training on the affected limb, totaling 16 training sessions. Participants in both groups will also receive the standard rehabilitation program provided by the hospital. In the BFR-RT group, blood flow restriction will be achieved using an occlusion band placed on the most proximal portion of the affected limb. The physical therapist will ensure the band is not too tight, allowing one finger to pass through the band.

Data will be collected at three time points: post-surgery (week 0-1), mid-training (week 4-5), and post-training (week 9). Outcomes measured include skeletal muscle hypertrophy, strength (assessed using the 10RM scaled maximal isotonic strength), range of motion (ROM) of the knee joint, pain (assessed using a pain scale), and effusion (measured by knee joint circumference). Adherence rates, exercise session attendance, and adverse events will also be recorded.

Data will be analyzed using descriptive statistics, including mean and standard deviation, to describe adherence rates, exercise session attendance, and adverse events. Statistical tests such as chi-square tests and independent-samples t-tests will be used to assess differences between the two groups in baseline characteristics. Normality of data will be assessed using the Shapiro-Wilk test, and homogeneity of variances will be checked using Levene's test. If the data is normally distributed, the parametric test will be applied on data, otherwise non-parametric tests will be applied.

Eligibility criteria: 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

Primary outcomes:
measure: Range of Motion
timeFrame: eight weeks
measure: Quadricep Strength
timeFrame: eight weeks
measure: Knee Pain
timeFrame: eight weeks
Secondary outcomes:
measure: Quadricep Size
timeFrame: eight weeks
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Rehman Medical Institute
state: KPK
Study officials:
affiliation: Rehman Medical Institute
name: Bilal Khan, Master's
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.