Ignite Creation Date:
2024-07-17 @ 11:13 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06480032
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-04-15
Brief Title:
Low-Load Blood Flow Restriction Training vs Traditional Resistance Training Exercises Following ACLR Surgery
Sponsor:
Abasyn University Peshawar
Organization:
Abasyn University Peshawar
Study Overview
Official Title:
Low-Load Blood Flow Restriction Training vs Traditional Resistance Training Exercises Following Anterior Cruciate Ligament Reconstruction Surgery A Pilot Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main objectives 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
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 Levenes test If the data is normally distributed the parametric test will be applied on data otherwise non-parametric tests will be applied
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 Levenes test If the data is normally distributed the parametric test will be applied on data otherwise non-parametric tests will be applied
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None