Immunometabolic Mechanisms of Blood Flow Restriction (BFR) Training After Anterior Cruciate Ligament Reconstruction

Part of paid clinical trials in Milford, Connecticut.

Sponsor
Yale University
Study ID
NCT05012982
Status
Recruiting
Apply to this trial

Conditions

  • Anterior Cruciate Ligament Reconstruction

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • AirBand — DEVICE
    The AirBands will be placed at each of the two training sessions and inflated while an ultrasound probe is placed over the femoral artery. The cuff will be inflated until the artery reaches 60% occlusion. The force will be applied using a wireless Bluetooth signal; participants will not be asked to adjust the device. Participants will be observed by a certified Personal Therapist throughout the training session in order to determine compliance and ensure safety as is standard protocol for a physical therapy session.
  • uninflated AirBand — DEVICE
    Uninflated AirBand will be used as the control intervention during the session in which BFR is not performed

Study Details

This is a crossover phase 4 study to evaluate the impact of blood flow restriction on immunometabolism and gene expression in immune cells in individuals undergoing rehabilitation from anterior cruciate ligament reconstruction.

Key Dates

Start date
Feb 16, 2023
Status verified
Dec 2025
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: AirBand followed by uninflated AirBand
    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,
  • Experimental: Uninflated Airbnd followed by AirBand
    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,

Primary Outcome Measure

Change in Leukocyte metabolic gene expression [ Time Frame: Baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Yale New Haven HospitalMilfordConnecticut06461
Rachel Perry, PhD
[email protected],
203-506-5179
Andin Fosam, BS
[email protected]
6095787713
Rachel Perry, PhD (PRINCIPAL_INVESTIGATOR)
Gaylord Outpatient Physical Therapy North Haven ClinicNorth HavenConnecticut06473
Kelsey Cognetta (PRINCIPAL_INVESTIGATOR)

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By research site
Yale New Haven Hospital· Milford, CTGaylord Outpatient Physical Therapy North Haven Clinic· North Haven, CT

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