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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 below
Select...
I am between 18 and 60 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
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

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 more
Secondary 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,

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,852 Previous Clinical Trials
2,738,421 Total Patients Enrolled
Rachel Perry, PhDPrincipal InvestigatorYale University

Media Library

AirBand (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05012982 — N/A
Anterior Cruciate Ligament Reconstruction Research Study Groups: Uninflated Airbnd followed by AirBand, AirBand followed by uninflated AirBand
Anterior Cruciate Ligament Reconstruction Clinical Trial 2023: AirBand Highlights & Side Effects. Trial Name: NCT05012982 — N/A
AirBand (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05012982 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any slots available for prospective participants in this research trial?

"Affirmative. As demonstrated by the clinicaltrials.gov page, this research project is presently recruiting participants; it was first posted on March 15th 2022 and has been recently updated April 11th of that same year. The trial requires 20 patients from a single location to take part in its study."

Answered by AI

Do participants must be aged sixty or below to qualify for the clinical trial?

"Prospective participants in this clinical trial should be aged between 18 and 60. Those younger or older than that range may find studies suited to them, as there are 2 trials designed for under-18s and another two targeting seniors over 65."

Answered by AI

How many volunteers have signed up to take part in this trial?

"Affirmative. Clinicaltrials.gov displays that the clinical trial, which was first promoted on March 15th 2022, is seeking volunteers. This research requires 20 patients from 1 medical facility."

Answered by AI

Does the Federal Drug Administration recognize AirBand in its deflated state?

"The safety of uninflated AirBand is rated a 3, as this treatment has been authorized by Phase 4 clinical trials."

Answered by AI

Who is eligible to partake in the research endeavor?

"This trial seeks 20 participants with an anterior cruciate ligament reconstruction aged 18 to 60. Partakers must be of any gender, and in good health without underlying medical conditions that would put them at further risk. Additionally, they are required to commit to the study's procedures over two visits within a one-week period."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Immunometabolic Mechanisms of Blood Flow Restriction (BFR) Training After Anterior Cruciate Ligament Reconstruction
2023. "Immunometabolic Mechanisms of Blood Flow Restriction (BFR) Training After Anterior Cruciate Ligament Reconstruction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05012982.
~2 spots leftby Jul 2024
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