T Cell Responses to Various Levels of Exercise Stress

Effects of High- and Moderate-intensity Exercise on T Cell Function in Healthy Young Men

The objective of this project is to quantify the immunoendocrine response to acute stress events combining both physical and psychological challenges. This work will serve as a pilot project examining differential stress induction in response to exercise. Participants will have an instructor with prior military training lead a two-hour training session for 10 recreationally fit male volunteers. You will be randomly assigned to a high-intensity training group to participate in the "military style" training and a low-intensity training group who will participate in a low-intensity cardiovascular training protocol. Blood samples will be collected from you prior to and following the exercise session and these samples will be analyzed for endocrine measures as well as markers of immune function to include chemokines and cytokines.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Exercise

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Lawrence, Kansas, United States, 66045
      • University of Kansas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

All subjects will be screened using a health-history questionnaire for contradictions to exercise by American College of Sports Medicine (ACSM) guidelines

Inclusion Criteria:

• Recreationally active
• Between the ages of 18-40,
• Healthy
• Non-obese (BMI <28 kg/m2)
• Non-smoking
• Free of metabolic or cardiovascular diseases.

Exclusion Criteria:

• Unhealed Fractures
• Thrombophlebitis (blood clots)
• Recent Surgery (within the last three months)
• Recent Uncontrolled Bruising
• Osteomyelitis (acute or chronic bone infection)
• Myositis Ossificans (hardened scarring in muscle tissue of the thigh).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Moderate intensity exercise; Subjects will participate in a 100 min bout of exercise led by an exercise physiologist doing the same exercises as the high-intensity group, but at a lower effort level. Exercise consists of of a mix of running activities (≤ 400 m); body weight exercises, such as burpees and lunges; and exercises, such as crunches and squats utilizing 20.4 kg weight plates, but performed at a pace allowing for in-session recovery. Scheduled 5 min rests will be included at 30, 60, and 85 min and MI subjects will be similarly encouraged to consume water and/or the carbohydrate/electrolyte drink. The researchers will obtain a blood sample from you prior to and immediately following the exercise, as well as one, four and six hours post-exercise.	Other: Exercise; Subjects in the two groups preformed 90-100 minutes of exercise at different intensities.; Other Names: Moderate-intensity; High-intensity
Experimental: High intensity exercise; Subjects in this group will participate in an exercise session that is representative of a training event experienced by cadets preparing for military competitions. All exercises will consist of a mix of running activities (≤ 400 m); body weight exercises, such as burpees and lunges; and exercises, such as crunches and squats utilizing 20.4 kg weight plates; with rapidly occurring exercise transitions to prevent recovery. The exercise bout will last a total of 100 min. Scheduled 5 min rests will be inserted at 30, 60, and 85 min. During the scheduled rest periods, subjects will be encouraged to consume water and/or the carbohydrate/electrolyte drink. The researchers will obtain a blood sample from you prior to and immediately following the exercise, as well as one, four and six hours post-exercise.	Other: Exercise; Subjects in the two groups preformed 90-100 minutes of exercise at different intensities.; Other Names: Moderate-intensity; High-intensity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
T cell proliferation	Blood samples were collected using standard venipuncture technique. Blood samples were obtained at baseline, immediately post-exercise (0h), 1 hour post (1h), 4 hours (4h), and 6 hours (6h) post-exercise in heparin vacutainer tubes. Peripheral blood mononuclear cells (PBMC) were isolated using Ficoll-Paque PLUS density gradient centrifugation. Total T cells were purified from washed PBMC by E-rosetting. T cell proliferation was analyzed in response to co-stimulation through CD3+CD28 using plate-bound antibodies, or phytohaemagglutinin (PHA) treatment, or no simulation. Cells were incubated for 6 days at 37˚C in a humidified incubator with 5% CO2 and then analyzed by flow cytometry. Cells were analyzed by flow cytometry using anti-CD3-APC, and anti-CD152-PE antibodies immediately after CD3+ T cell isolation (0 h) and following 6 d in culture using an Accuri C6 flow cytometer.	6.5 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Catecholamines (hormones)	Blood will be collected in a vial containing EDTA (6 ml) for analysis of catecholamines. Plasma for catecholamine (epinephrine and norepinephrine) analyses was obtained by centrifugation at 2000 g for 10 min at 4˚C. The supernatant was removed and stored at -80˚C until analysis. Catecholamine concentrations will be determined using BI-CAT ELISA kits and performed per the manufacturer's instructions. The samples were measured at 450 nm using a Synergy HT microplate reader. The blood samples will be obtained at the same time as for the primary outcomes (prior to and following exercise as well as one, four and six hours post-exercise.	6.5 hours
Complete Blood Count	Peripheral blood will be collected in a vial containing EDTA (6 ml) for analysis of complete blood counts (CBC). These vials will be sent to a commercial clinical laboratory (Quest Diagnostics) for the CBC measures. The blood samples will be obtained at the same time as for the primary outcomes (prior to and following exercise as well as one, four and six hours post-exercise).	6.5 hours
Cortisol	Blood will be collected in a vial containing EDTA (6 ml) for analysis of cortisol. These vials will be sent to a commercial clinical laboratory (Quest Diagnostics) for the cortisol measures. The blood samples will be obtained at the same time as for the primary outcomes (prior to and following exercise as well as one, four and six hours post-exercise).	6.5 hours

Collaborators and Investigators

• Sponsor: University of Kansas

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2015
• Primary Completion (Actual): May 12, 2016
• Study Completion (Actual): May 12, 2016

Study Registration Dates

• First Submitted: October 3, 2024
• First Submitted That Met QC Criteria: October 10, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 10, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Immune; Cytokine; Flow Cytometry; Immunoendocrine
• Other Study ID Numbers: STUDY00001969; ONR N000141410202 (Other Grant/Funding Number: Office of Navel Research)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: Until December 29, 2025
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No