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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.
This is a single-blind crossover phase 4 study in which participants will be randomized as to the order in which each of two sessions are completed. Although all analyses will be performed by a blinded investigator and participants will wear an uninflated AirBand as the control intervention during the session in which BFR is not performed, participants will likely know which of the two interventions is being performed on which study day.
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.
The study team hypothesizes that the BFR will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AirBand followed by uninflated AirBand | Experimental | 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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| Uninflated Airbnd followed by AirBand | Experimental | 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, |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise |
| 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. | Baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise |
| 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). | Baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise |
| Change in glucose concentrations | Glucose may be between 4 and 15 mM. Higher glucose may be indicative of diabetes. | Baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise |
| Change in lactate concentrations | Lactate may be between 0.2 and 8 mM. Higher lactate may be indicative of a more intense exercise response. | Baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rachel Perry, PhD | Contact | 203-506-5179 | rachel.perry@yale.edu | |
| Andin Fosam, BS | Contact | 609-578-7713 | andin.fosam@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Rachel Perry, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Hospital | Recruiting | Milford | Connecticut | 06461 | United States |
Data will be published, anonymized. Other than publication, the investigators do not plan to share data with other researchers.
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| uninflated AirBand | Device | Uninflated AirBand will be used as the control intervention during the session in which BFR is not performed |
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| Change in fatty acid concentrations | Saturated and unsaturated fatty acid concentrations will be measured. Each fatty acid may range from 0 to 5 mM. Increased fatty acid concentrations may be indicative of a greater stress response to exercise. | Baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise |
| Change in insulin concentrations | Insulin may range from 0 to 100 uU/ml. Higher insulin may indicate a greater stress response. | Baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise |
| Change in glucagon concentrations | Glucagon may range from 0 to 500 pM. Higher glucagon may indicate lower blood glucose concentrations. | Baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise |
| Change in catecholamines concentrations | Epinephrine and norepinephrine (also known as adrenaline and noradrenaline) will be measured. They can range from 0-1000 nM. Higher catecholamide concentrations may indicate a greater stress response to training. | Baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise |
| 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. |
| Baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise |
| Change in creatine kinase | Creatine kinase concentration | Baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise |
| Gaylord Outpatient Physical Therapy North Haven Clinic | Recruiting | North Haven | Connecticut | 06473 | United States |
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