Immunometabolic Mechanisms of Blood Flow Restriction (BFR) Training After Anterior Cruciate Ligament Reconstruction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorYale University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for two study visits at least 1 week apart
All genders, between 18 and 60 years of age
In good general health without any underlying medical conditions or prior injury that would place the subject at risk of further injury/illness by participating in the study
Disqualifiers
Serious medical conditions including cardiovascular, metabolic (diabetes), rheumatologic, pulmonary, or musculoskeletal.
Multiple ligament ruptures or trauma
Rheumatoid arthritis or other significant comorbidities
Lower extremity vascular pathology, including history of deep vein thrombosis
Trial design
Design model
Crossover
Treatments tested in this trial
AirBand
DeviceThe 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
DeviceUninflated AirBand will be used as the control intervention during the session in which BFR is not performed
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: AirBand followed by uninflated AirBandExperimental treatment 2 interventions
Group B: Uninflated Airbnd followed by AirBandExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Change in Leukocyte metabolic gene expression
Gene expression measured by RNAseq. Because of the nature of RNAseq it is not possible to provide a comprehensive list of gene expression that will be measured; however, genes of particular interest include Slc2a3, Slc2a1, Slc2a4, Slc16a3, PC, Pdha1, Acc1, Fasn.
Time frame
Baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise2
Change in leukocyte substrate preference
Fractional contributions of glucose and fatty acids to total mitochondrial oxidation will be measured. Each can fuel between 0 and 100% of total mitochondrial oxidation.
Time frame
Baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise3
Change in amino acids concentrations
Concentrations of all amino acids (alanine, arginine, asparagine, aspartic acid, cysteine, glutamine, glutamate, glycine, histidine, isoleucine, leucine, lysine, methionine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine, valine). Amino acid concentrations may be between 1 and 500 uM. Higher amino acid concentrations may indicate greater muscle breakdown (proteolysis).
Time frame
Baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise4
Change in glucose concentrations
Glucose may be between 4 and 15 mM. Higher glucose may be indicative of diabetes.
Time frame
Baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exerciseSecondary outcomes
1
Whether a baseline immunometabolic blueprint predicts the immunometabolic response to resistance training or to BFR.
Correlation between Outcomes 1-9 at 0, 30 and 60 minutes after training, to Outcomes 1-9 before training
Time frame
Baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise2
Whether the immunometabolic response correlates with patient-reported soreness following a physical therapy training session.
the soreness scale is 0 to 10, with 0 as no pain or soreness and 10 as pain or soreness as bad as it could possibly be.
Time frame
Baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise3
Change in creatine kinase
Creatine kinase concentration
Time frame
Baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exerciseSponsors and contacts
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Source ClinicalTrials.gov