Exercise-induced Effects on Immune Parameters in Healthy Participants

NCT05826496 | Completed DMC

• 2 other identifiers: H-23006672IN2301
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

Exercise has been shown to influence the immune system and, for example, improve anti-viral immune response. However, knowledge of how exercise impacts the immune system is still lacking. Therefore, the goal of this clinical study is to perform a comprehensive multi-parameter analysis of immunological parameters in healthy participants before and after one bout of high-intensity aerobic exercise. The primary endpoint of this study is to determine the exercise-induced changes of anti-viral T cell immunity in peripheral blood against common and recurrent viruses. Up to 70 healthy participants in the age between 18 and 75 will be recruited. The first visit will be for prescreening the health status, answering questionnaires and providing a capillary blood sample for HLA screening. HLA-A2 positive participants will continue on the trial with a VO2 max test for Visit 2 and the supervised aerobic medium- to high-intensity (90% VO2 max) exercise session for Visit 3. Peripheral blood samples will be taken pre-exercise, within 2 minutes post-exercise and 60 minutes post-exercise. These findings may pave the way to define serum markers or cellular immunological traits that provide new insight into how exercise promotes powerful and sustained cellular immune responses.

Conditions

Healthy

Keywords

Acute exercise; Virus-specific T cells; High-intensity interval training; T cell; Acute stress response; NK cell; Inflammation; Exercise immunology; Catecholamines

Outcome Measures

Primary Outcomes (1)

• Virus-specific T cell responses

  Investigate the number of virus-reactive CD8+ T cells at baseline, within 2 minutes after cessation and 60 minutes after cessation of the exercise bout in peripheral blood using DNA-barcoded peptide-MHC multimer assay.

  6 months

Secondary Outcomes (2)

• Phenotypes of exercise-mobilized immune cells

  6 months

• Circulating soluble markers

  1 year

Study Arms (1)

Exercise

EXPERIMENTAL

HLA-A2 positive participants will perform one bout of high-intensity interval training.

Other: Exercise

Interventions

Exercise OTHER

The supervised high-intensity interval training is conducted on bicycle ergometers at 85-95% maximal workload. The high-intensity interval sequences will be separated by two steady state sequences. Blood samples are collected at baseline, 2 min and 60 min post-exercise.

Exercise

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have the ability to speak and read English and/or Danish.
• Agree to avoid alcohol, nonprescription drugs, and strenuous exercise for 24 hours prior VO2 max test and exercise intervention.
• Signed informed consent.

You may not qualify if:

• Autoimmune disease requiring active treatment.
• A condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications. Inhaled or topical steroids and adrenal replacement doses ≤ 10 mg daily prednisone equivalents are permitted
• Use of medication known to affect the immune system (regular use of ibuprofen/aspirin or beta-blockers).
• Any systemic infections with fever within the last 4 weeks before the exercise intervention.
• Use of any illegal drugs (e.g., cocaine, amphetamine).
• Conditions with high risk for complications during exercise: Unstable medical disease, condition, or history of serious or concurrent illness; any medical condition that might be aggravated by exercise training or that cannot be controlled, including, but not restricted to congestive heart failure (NYHA class III-IV), unstable angina pectoris, implantable cardioverter defibrillator (ICD), or myocardial infarction within 6 months.

Sponsors & Collaborators

• Per thor Straten: lead

Study Sites (1)

Herlev Hospital

Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

Inflammation

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Gitte Holmen Olofsson, PhD

  CCIT, Herlev Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: HLA-A2 positive participants complete one acute bout of supervised aerobic high-intensity exercise

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: April 24, 2023
• Study Start: March 15, 2023
• Primary Completion: December 31, 2024
• Study Completion: February 10, 2025
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)