Anterior Cruciate Ligament ReconstructionNCT05012982
Immunometabolic Mechanisms of Blood Flow Restriction (BFR) Training After Anterior Cruciate Ligament Reconstruction
A study testing AirBand and uninflated AirBand in people with Anterior Cruciate Ligament Reconstruction, run by Yale University at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction
- What is being tested?
- AirBand and uninflated AirBand
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Feb 2023to 15 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
- Those with a history of sickle cell trait or disease
- Use of anticoagulant medications
Show all 10Show fewer
- Pregnancy
- Treatment with another investigational drug or other intervention within one month of Study Day 1
- Current smoker or tobacco use within 3 months of Study Day 1
- Febrile illness within 2 weeks of Study Day 1
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Yale New Haven Hospital
Milford, Connecticut, 06461
Gaylord Outpatient Physical Therapy North Haven Clinic
North Haven, Connecticut, 06473
About this study
Official title: Immunometabolic Mechanisms of Blood Flow Restriction Training After Anterior Cruciate Ligament Reconstruction
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.
Read the detailed description
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:
- Promote an anabolic immunometabolic signature, reflected in the composition of serum amino acid concentrations and anabolic hormone content
- Enhance anaerobic glycolysis in leukocytes (which has been associated with increased activation in other settings (Marelli-Berg and Jangani, 2018; Pearce and Pearce, 2013))
- Increase leukocyte glucose and pyruvate concentrations, which corresponds to acute energy provision to promote repair
- Being tested
- AirBand, uninflated AirBand
- Keywords
- AirBand
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AirBandDevice
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 AirBandDevice
Uninflated AirBand will be used as the control intervention during the session in which BFR is not performed
| Study group | Role | What they receive |
|---|---|---|
| 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, Receives: Device: AirBand; Device: uninflated AirBand |
| 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, Receives: Device: AirBand; Device: uninflated AirBand |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise
Secondary outcomes (3)
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
Measured: 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.
Measured: Baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise
Change in creatine kinase
Creatine kinase concentration
Measured: Baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start16 Feb 2023
- Primary completion15 May 2026
- Study completion15 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament ReconstructionStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel Perry, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05012982
- Sponsor's protocol ID
- 2000030152
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2021
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be published, anonymized. Other than publication, the investigators do not plan to share data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunometabolic Mechanisms of Blood Flow Restriction Training After Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT05012982
- Acronym / sponsor ID
- 2000030152
- Keywords
- AirBand
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 16 Feb 2023 (actual)
- Primary completion
- 15 May 2026 (actual)
- Study completion
- 15 May 2026 (actual)
- First posted
- 19 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Promote an anabolic immunometabolic signature, reflected in the composition of serum amino acid concentrations and anabolic hormone content
- Enhance anaerobic glycolysis in leukocytes (which has been associated with increased activation in other settings (Marelli-Berg and Jangani, 2018; Pearce and Pearce, 2013))
- Increase leukocyte glucose and pyruvate concentrations, which corresponds to acute energy provision to promote repair
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AirBand followed by uninflated AirBand | Experimental | Device: AirBand, Device: uninflated AirBandThe 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, |
| Uninflated Airbnd followed by AirBand | Experimental | Device: AirBand, Device: uninflated AirBandThe 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, |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
- Those with a history of sickle cell trait or disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AirBandThe 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. | Device | AirBand followed by uninflated AirBand, Uninflated Airbnd followed by AirBand |
| uninflated AirBandUninflated AirBand will be used as the control intervention during the session in which BFR is not performed | Device | AirBand followed by uninflated AirBand, Uninflated Airbnd followed by AirBand |
Primary outcome
Change in Leukocyte metabolic gene expression
Time frame: Baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise
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.
Change in leukocyte substrate preference
Time frame: Baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise
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.
Change in amino acids concentrations
Time frame: Baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise
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).
Change in glucose concentrations
Time frame: Baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise
Glucose may be between 4 and 15 mM. Higher glucose may be indicative of diabetes.
Change in lactate concentrations
Time frame: Baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise
Lactate may be between 0.2 and 8 mM. Higher lactate may be indicative of a more intense exercise response.
Change in fatty acid concentrations
Time frame: Baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise
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.
Change in insulin concentrations
Time frame: Baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise
Insulin may range from 0 to 100 uU/ml. Higher insulin may indicate a greater stress response.
Change in glucagon concentrations
Time frame: Baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise
Glucagon may range from 0 to 500 pM. Higher glucagon may indicate lower blood glucose concentrations.
Change in catecholamines concentrations
Time frame: Baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise
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.
3 secondary outcomes
Whether a baseline immunometabolic blueprint predicts the immunometabolic response to resistance training or to BFR.
Time frame: 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.
Time frame: Baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise
Change in creatine kinase
Time frame: Baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No. Data will be published, anonymized. Other than publication, the investigators do not plan to share data with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Perry, PhD principal investigator
Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AirBand and uninflated AirBand in people with Anterior Cruciate Ligament Reconstruction, run by Yale University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.