High-Intensity Interval Training and Regulatory T Cells

NCT04774484 | Withdrawn DMC

• 1 other identifier: 0001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

End Stage Renal Disease

Keywords

high intensity; interval training; exercise; obesity; inflammation; Treg

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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

  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

  Baseline- and at 12 weeks post-HIIT intervention

Secondary Outcomes (18)

• Change from baseline Serum Interleukin-6 (IL6) at 12 weeks post HIIT intervention

  Baseline- and at 12 weeks post-HIIT intervention

• Change from baseline Serum Tumor Necrosis Factor- Alpha (TNF-alpha) at 12 weeks post HIIT intervention

  Baseline- and at 12 weeks post-HIIT intervention

• Change from baseline Serum Leptin at 12 weeks post HIIT intervention

  Baseline- and at 12 weeks post-HIIT intervention

• Change from baseline Blood Glucose at 12 weeks post HIIT intervention

  Baseline- and at 12 weeks post-HIIT intervention

• Change from baseline Serum Triglycerides at 12 weeks post HIIT intervention

  Baseline- and at 12 weeks post-HIIT intervention

Other Outcomes (35)

• Change from baseline Serum IL10 at 12 weeks post HIIT intervention

  Baseline- and at 12 weeks post-HIIT intervention

• Change from baseline Serum Interferon Gamma (IFNg) at 12 weeks post HIIT intervention

  Baseline- and at 12 weeks post-HIIT intervention

• Change from baseline Serum Epinephrine at 12 weeks post HIIT intervention

  Baseline- and at 12 weeks post-HIIT intervention

Study Arms (1)

All subjects will be in one arm

EXPERIMENTAL

Both Lean and Obese, End-Stage Renal Disease (ESRD) patients and normal volunteers will be in one arm, that will receive the High Intensity Interval Training intervention.

Other: High Intensity Interval Training

Interventions

High Intensity Interval Training OTHER

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.

All subjects will be in one arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 65 years old.
• BMI between 18.5 and 25 or above 30. Rationale: we want to include "obesity" as categorical covariate in the influence of HIIT and discriminate the participants between "lean" (BMI range 18.5-25) and "obese" (BMI \> 30)
• Sedentary lifestyle (fewer than 5,000 steps per day)
• Fluent in English, able to understand and provide informed consent.
• Subjects willing to participate in the study and comply with study requirements as evidenced by signed Institutional Review Board (IRB)-approved informed consent.

You may not qualify if:

• Age under 18 or over 65
• BMI under 18.5 or between 25 and 30.
• Active lifestyle (more than 5,000 steps per day).
• Previous chronic use of systemic glucocorticoids, immune-suppressors or immuno-modulators in the preceding 3 months.
• Patients with significant or active infection: HIV negative by ELISA or reverse transcription polymerase chain reaction (RT-PCR) \[if ELISA is positive and RT-PCR is negative, the ELISA is considered false positive\]; negative serology for Hepatitis B and C.
• Active malignancy or history of malignancy within 1 year.
• Be pregnant or breastfeeding.
• Hemoglobin less than 9.0 g/dl at the time of blood drawing.
• Platelet count less than 100,000/\* at the time of blood drawing.
• White blood count less than 4 and/or Absolute Neutrophil Count less than 1500/\* at the time of blood drawing.
• Participation in any other study that involved investigational drug or regimens in the preceding 12 months.
• History of delayed or abnormal wound healing.
• Any immuno-related condition, chronic illness or prior treatment which, in the opinion of the investigator, precludes study participation.
• Inability or unwillingness of participant to comply with study protocol or procedures.
• Impaired consent capacity.

Sponsors & Collaborators

• Francesc Marti: lead

Study Sites (1)

University of Kentucky Transplant Center

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Motor Activity; Obesity; Inflammation

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Francesc Marti, PhD

  University of Kentucky, College of Medicine / Transplant Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 11, 2020
• First Posted: March 1, 2021
• Study Start: January 1, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 14, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)