NCT06638684

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2016

Completed
8.4 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

1.2 years

First QC Date

October 3, 2024

Last Update Submit

October 10, 2024

Conditions

Keywords

ImmuneCytokineFlow CytometryImmunoendocrine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Catecholamines (hormones)

    6.5 hours

  • Complete Blood Count

    6.5 hours

  • Cortisol

    6.5 hours

Study Arms (2)

Moderate intensity exercise

ACTIVE COMPARATOR

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

High intensity exercise

EXPERIMENTAL

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

Interventions

Subjects in the two groups preformed 90-100 minutes of exercise at different intensities.

Also known as: Moderate-intensity, High-intensity
High intensity exerciseModerate intensity exercise

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas

Lawrence, Kansas, 66045, United States

Location

Related Publications (1)

  • Siedlik J, Deckert J, Dunbar A, Bhatta A, Gigliotti N, Chan M, Benedict S, Bubak M, Vardiman J, Gallagher P. Acute high-intensity exercise enhances T cell proliferation compared to moderate-intensity exercise. Appl Physiol Nutr Metab. 2025 Jan 1;50:1-12. doi: 10.1139/apnm-2024-0420.

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 3, 2024

First Posted

October 15, 2024

Study Start

February 20, 2015

Primary Completion

May 12, 2016

Study Completion

May 12, 2016

Last Updated

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Until December 29, 2025

Locations