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Behavioural Intervention
BFR Training for ACL Recovery
N/A
Recruiting
Led By Rachel Perry, PhD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
All genders, between 18 and 60 years of age
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise
Awards & highlights
Study Summary
This trial will study how well blood flow restriction affects immunity and gene expression in people recovering from ACL surgery.
Who is the study for?
This trial is for individuals aged 18-60 who are in good health and currently rehabilitating from anterior cruciate ligament reconstruction. Participants must be willing to follow the study procedures and have no recent smoking history, febrile illness, vascular issues in legs, or serious medical conditions like diabetes or rheumatoid arthritis.Check my eligibility
What is being tested?
The study is testing the effects of blood flow restriction training using an AirBand device during rehabilitation after ACL surgery. It's a phase 4 crossover study focusing on how this method affects immune cell metabolism and gene expression.See study design
What are the potential side effects?
While specific side effects are not listed, potential risks may include discomfort due to restricted blood flow with the AirBand or possible injury if pre-existing health conditions are present.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 60 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Leukocyte metabolic gene expression
Change in amino acids concentrations
Change in catecholamines concentrations
+6 moreSecondary outcome measures
Change in creatine kinase
Whether a baseline immunometabolic blueprint predicts the immunometabolic response to resistance training or to BFR.
Whether the immunometabolic response correlates with patient-reported soreness following a physical therapy training session.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Uninflated Airbnd followed by AirBandExperimental Treatment2 Interventions
The order of study days will be randomized. participants will wear an uninflated AirBand as the control intervention during the session in which BFR is not performed,
Group II: AirBand followed by uninflated AirBandExperimental Treatment2 Interventions
The order of study days will be randomized. participants will wear an uninflated AirBand as the control intervention during the session in which BFR is not performed,
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Who is running the clinical trial?
Yale UniversityLead Sponsor
1,863 Previous Clinical Trials
2,742,561 Total Patients Enrolled
Rachel Perry, PhDPrincipal InvestigatorYale University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had issues with blood flow in my legs, including clots.I am currently taking blood thinners.You are pregnant.I am willing and able to follow the study rules and attend two visits a week apart.I do not have serious heart, metabolic, lung, joint, or muscle conditions.You cannot have participated in another research study or received a new medical treatment within the month before the start of this study.I have had multiple ligament injuries due to trauma.I have rheumatoid arthritis or another significant health condition.I am between 18 and 60 years old.I am in good health with no conditions that would risk my safety in the study.You have smoked or used tobacco within 3 months before the study.I have not had a fever or flu-like illness in the last 2 weeks.I have a history of sickle cell disease or trait.
Research Study Groups:
This trial has the following groups:- Group 1: Uninflated Airbnd followed by AirBand
- Group 2: AirBand followed by uninflated AirBand
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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