RecruitingNot Applicable

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

United States20 participantsStarted 2023-02-16

Plain-language 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.

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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
✕. Pregnancy
✕. Treatment with another investigational drug or other intervention within one month of Study Day 1

What they're measuring

Change in Leukocyte metabolic gene expression

Timeframe: Baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise

Change in leukocyte substrate preference

Timeframe: Baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise

Change in amino acids concentrations

Timeframe: Baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise

Change in glucose concentrations

Timeframe: Baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise

Change in lactate concentrations

Timeframe: Baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise

Change in fatty acid concentrations

Timeframe: Baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise

Change in insulin concentrations

Timeframe: Baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise

Trial details

NCT IDNCT05012982

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05

Contact for this trial

Rachel Perry, PhD

203-506-5179 rachel.perry@yale.edu

View on ClinicalTrials.gov More Anterior Cruciate Ligament Reconstruction trials

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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
✕. Pregnancy
✕. Treatment with another investigational drug or other intervention within one month of Study Day 1

What they're measuring

Change in Leukocyte metabolic gene expression

Timeframe: Baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise

Change in leukocyte substrate preference

Timeframe: Baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise

Change in amino acids concentrations

Timeframe: Baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise

Change in glucose concentrations

Timeframe: Baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise

Change in lactate concentrations

Timeframe: Baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise

Change in fatty acid concentrations

Timeframe: Baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise

Change in insulin concentrations

Timeframe: Baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise