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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

Must not have

Lower extremity vascular pathology, including history of deep vein thrombosis

Serious medical conditions including cardiovascular, metabolic (diabetes), rheumatologic, pulmonary, or musculoskeletal.

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

No Placebo-Only Group

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.

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.

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 below

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I am between 18 and 60 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had issues with blood flow in my legs, including clots.

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I do not have serious heart, metabolic, lung, joint, or muscle conditions.

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I am currently taking blood thinners.

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I have had multiple ligament injuries due to trauma.

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I have a history of sickle cell disease or trait.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Leukocyte metabolic gene expression

Change in amino acids concentrations

Change in catecholamines concentrations

+6 more

Secondary study objectives

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.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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,

0 / 6Eligibility criteria met