Regulatory T cells (Tregs) are a small population of T cells compromising of 1% to 5% of the total T cells in the body but they are playing a fundamental role in the maintenance of the immune homeostasis. These cells modulate the immune system by suppressing the effector activity and thus preventing autoimmune diseases and chronic inflammatory processes. Treg cell numbers have shown to increase with physical activity, and this increment has been directly correlated with exercise intensity. These results suggest that the increased Treg frequency may contribute to the beneficial effects of exercise on disorders associated with autoimmune disease or chronic low-grade inflammation such as atherosclerosis, diabetes mellitus, chronic kidney disease or cancer. The overall purpose of this study is to determine the influence High-intensity interval training (HIIT) on the frequency and quality of peripheral Treg cells.
Tregs have been studied in clinical practice for different therapeutic applications. In the past several years there has been a significant interest in the transplant community to develop tolerance in order to substantially decrease or even eliminate the need of immuno-suppressive regimens. A growing body of evidence recognizes the balance between graft-reactive effector cells and graft-protective suppressor Treg cells as the ultimate determinant of long-term allograft survival. As a result, there is a major interest in transplantation to enhance the suppressor immune response as an alternative or complementary approach to reach a clinical tolerogenic state and preserve graft function. Exercise improves baseline immune function and helps to maintain immune homeostasis. Treg cell numbers have shown to increase with physical activity, and this increment has been directly correlated with exercise intensity. These results suggest that the increased Treg frequency may contribute to the beneficial effects of exercise on disorders associated with autoimmune disease or chronic low-grade inflammation such as atherosclerosis, diabetes mellitus, chronic kidney disease or cancer. Primary Objectives: The overall purpose of this study is to determine the influence High-intensity interval training (HIIT) on the frequency and quality of peripheral Treg cells. Secondary Objectives: Effects of HIIT in other T cell populations. Effects of HIIT in plasma concentration of inflammatory and metabolic markers. Effects of HIIT in obese vs lean. Design: This is a prospective, single center, single-arm "pre-test/post-test" study designed to evaluate the safety, feasibility and initial efficacy of a 12-week HIIT regimen to increase the frequency and quality of peripheral Treg cells. All participants will have a pre-test (baseline) evaluation followed by a treatment and then a post-test.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
After the acclimatization session and assessment of eligibility, a graded exercise test (GXT) will be given to the participant. After checking their vitals, the HIIT program will be performed on recumbent cycles. The first two weeks of training will consist of a gradual ramp where subjects will perform a moderate intensity cycling program consisting of a 5-minute warm up followed by progressively longer continuous cycling starting at 15 minutes and progressing up to 30 minutes prior to starting the HIIT training. For the HIIT training subjects will perform 5 minutes of low to moderate steady state cycling to warm up. Following the warm up, the subjects will complete the 4x4 HIIT program. This will consist of 4 minutes of cycling at 85% of the subject's maximum heart rate (HR) followed by 4 minutes of a low intensity cycling period for recovery.
University of Kentucky Transplant Center
Lexington, Kentucky, United States
Change from baseline concentration of circulating Regulatory T cells (Tregs) in blood at 12 weeks post HIIT intervention
Change from baseline concentration of circulating Regulatory T cells (Tregs) in blood
Time frame: Baseline- and at 12 weeks post-HIIT intervention
Change from baseline Serum C-Reactive protein at 12 weeks post HIIT intervention
Change from baseline concentration of serologic cytokines/growth factors/metabolites
Time frame: Baseline- and at 12 weeks post-HIIT intervention
Change from baseline Serum Adiponectin at 12 weeks post HIIT intervention
Change from baseline concentration of serologic cytokines/growth factors/metabolites
Time frame: Baseline- and at 12 weeks post-HIIT intervention
Change from baseline expansion rates of TRegs (in vitro) at 12 weeks post HIIT intervention
Change from baseline expansion rates of TRegs
Time frame: Baseline- and at 12 weeks post-HIIT intervention
Change from baseline Serum Interleukin-6 (IL6) at 12 weeks post HIIT intervention
Change from baseline concentration of serologic cytokines/growth factors/metabolites
Time frame: Baseline- and at 12 weeks post-HIIT intervention
Change from baseline Serum Tumor Necrosis Factor- Alpha (TNF-alpha) at 12 weeks post HIIT intervention
Change from baseline concentration of serologic cytokines/growth factors/metabolites
Time frame: Baseline- and at 12 weeks post-HIIT intervention
Change from baseline Serum Leptin at 12 weeks post HIIT intervention
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Change from baseline concentration of serologic cytokines/growth factors/metabolites
Time frame: Baseline- and at 12 weeks post-HIIT intervention
Change from baseline Blood Glucose at 12 weeks post HIIT intervention
Concentration of serologic cytokines/growth factors/metabolites
Time frame: Baseline- and at 12 weeks post-HIIT intervention
Change from baseline Serum Triglycerides at 12 weeks post HIIT intervention
Change from baseline concentration of serologic cytokines/growth factors/metabolites
Time frame: Baseline- and at 12 weeks post-HIIT intervention
Change from baseline Total Cholesterol at 12 weeks post HIIT intervention
Change from baseline concentration of serologic cytokines/growth factors/metabolites
Time frame: Baseline- and at 12 weeks post-HIIT intervention
Change from baseline Low Density Lipoprotein (LDL) at 12 weeks post HIIT intervention
Change from baseline concentration of serologic cytokines/growth factors/metabolites
Time frame: Baseline- and at 12 weeks post-HIIT intervention
Change from baseline High Density Lipoprotein (HDL) at 12 weeks post HIIT intervention
Change from baseline concentration of serologic cytokines/growth factors/metabolites
Time frame: Baseline- and at 12 weeks post-HIIT intervention
Change from baseline Serum Insulin at 12 weeks post HIIT intervention
Change from baseline concentration of serologic cytokines/growth factors/metabolites
Time frame: Baseline- and at 12 weeks post-HIIT intervention
Change from baseline Intracellular Helios at 12 weeks post HIIT intervention
Change from baseline percentage and intensity of the Treg phenotype marker
Time frame: Baseline- and at 12 weeks post-HIIT intervention
Change from baseline Cell membrane CD36 at 12 weeks post HIIT intervention
Change from baseline percentage and intensity of the Treg phenotype marker
Time frame: Baseline- and at 12 weeks post-HIIT intervention
Change from baseline Cell membrane GLUT1 at 12 weeks post HIIT intervention
Change from baseline percentage and intensity of the Treg phenotype marker
Time frame: Baseline- and at 12 weeks post-HIIT intervention
Change from baseline Cell membrane Leptin-Receptor at 12 weeks post HIIT intervention
Change from baseline percentage and intensity of the Treg phenotype marker
Time frame: Baseline- and at 12 weeks post-HIIT intervention
Change from baseline Cell membrane TIGIT at 12 weeks post HIIT intervention
Change from baseline percentage and intensity of the Treg phenotype marker
Time frame: Baseline- and at 12 weeks post-HIIT intervention
Change from baseline Suppressor Activity at 12 weeks post HIIT intervention
Change from baseline activty of the Functional activity of TRegs
Time frame: Baseline- and at 12 weeks post-HIIT intervention
Change from baseline Intracellular FoxP3 at 12 weeks post HIIT intervention
Change from baseline percentage and intensity of the Treg phenotype marker
Time frame: Baseline- and at 12 weeks post-HIIT intervention
Change from baseline Membrane CD25 at 12 weeks post HIIT intervention
Change from baseline percentage and intensity of the Treg phenotype marker
Time frame: Baseline- and at 12 weeks post-HIIT intervention
Change from baseline Membrane CD127 at 12 weeks post HIIT intervention
Change from baseline percentage and intensity of the Treg phenotype marker
Time frame: Baseline- and at 12 weeks post-HIIT intervention