CytoHealth - A Study of the Inflammatory Response to Exercise

NCT06400212 | Completed

• 1 other identifier: 332548Y
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

By measuring cytokines and chemokines in healthy volunteers of a range of ages and physical fitness, the researchers want to establish how the body's immune system responds to undergoing a single, short test of maximal effort exercise. There is limited research looking at fitness testing and the immune system, particularly in less fit individuals and women. This may not only reveal more about how people respond to the stress of very hard exercise, but it has strong relevance to patients who are undergoing major cancer operations. The researchers know that better fitness improves the patients chances of doing well after a cancer operation, and so patients undergo an exercise test to assess their fitness before a cancer operation. The researchers use this information to guide their treatment during and after their operation. What the researchers do not know is how the immune system responds to the exercise test and how this might be reflected in how they do after the operation. By undertaking this study, in healthy volunteers, the researchers will not only gain an understanding of how best to assess the immune system during exercise testing, and the logistics of doing this, but it will provide us data that the researchers can compare to cancer patients collected in separate, future study. The potential implication being that information about the immune system could be assessed during exercise testing and enhance how the researchers manage those individuals during and after an operation, potentially improving their outcomes. To provide a good representation of the general adult population, the researchers will recruit volunteers from two universities and staff at a hospital. Individuals invited to participate will have a blood test to assess their levels of cytokines and chemokines before and after they complete an exercise test. The exercise test will be delivered at one site only, which is a university laboratory.

Conditions

Inflammatory Response; Immune System

Outcome Measures

Primary Outcomes (1)

• Serum cytokines

  Pre-designed multiplex flow assay panels (LEGENDplexTM BioLegend, San Diego, CA, USA) for detections of cytokines and chemokines will be used. These will be a human cytokines panel (IL- 1,2, 4, 5, 6, 9, 10, 13, 17A, 17F, 21 and 22. IFNg and TNFa) to evaluate the presence of systemic cytokine expression, and a proinflammatory chemokines panel \[MCP-1 (CCL2), RANTES (CCL5), IP-10 (CXCL10), Eotaxin (CCL11), TARC (CCL17), MIP-1α (CCL3), MIP-1β (CCL4), MIG (CXCL9), MIP-3α (CCL20), ENA-78 (CXCL5), GROα (CXCL1), I-TAC (CXCL11) and IL-8 (CXCL8)\] for the assessment of chemokine profiles. Serum levels of cytokines and chemokines will be determined from flow cytometry results using the free manufacturer data analysis software (www.biolegend.com/legendplex) and will be expressed as concentrations (pg/ml) calculated from a calibration curve

  Sample taken immediately prior and immediately after exercise testing

Secondary Outcomes (7)

• VO2 (oxygen consumption of participant during exercise)

  Data measured continuously during exercise testing (average duration of exercise test is 20 minutes)

• VCO2 (carbon dioxide exhaled by participant during exercise)

  Data measured continuously during exercise testing (average duration of exercise test is 20 minutes)

• Heart rate including maximum heart rate

  Data measured continuously during exercise testing (average duration of exercise test is 20 minutes)

• Respiratory exchange ratio (volume of expired carbon dioxide compared to volume of oxygen consumed) including the peak RER

  Data measured continuously during exercise testing (average duration of exercise test is 20 minutes)

• Anaerobic threshold

  Data measured continuously during exercise testing (average duration of exercise test is 20 minutes)

Study Arms (1)

Intervention

EXPERIMENTAL

Cardiopulmonary Exercise Testing

Other: Cardiopulmonary exercise test

Interventions

Cardiopulmonary exercise test OTHER

Participants undergo a cardiopulmonary exercise test following a standardised protocol used in national guidelines

Intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• Individuals aged less than 18 years or over 60 years.
• Individuals who refuse or are unable to give informed consent
• Individuals with an impairment, injury or disability that prevents them from pedalling on a static bicycle.
• Individuals who are deemed by a clinician to be classified on the American Society of Anesthesiologists Physical Status Classification System (ASA) as ASA III or ASA IV.
• Individuals who have had an acute infective or inflammatory illness in the last 7 days.
• Individuals who have undertaken moderate or high intensity exercise in the 24 hours prior to the exercise testing.
• Individuals who have a cardiac or respiratory condition which poses significant restrictions on their exercise capacity, as assessed by a clinician. Including but not limited to the following: recent myocardial infarction, acquired or inherited arrythmias or cardiomyopathies, presence of an implantable defibrillator or pacemaker, uncontrolled or severe COPD, uncontrolled asthma, pulmonary hypertension, pulmonary fibrosis.
• Individuals who are pregnant.
• Individuals who are known to have an active malignancy or have undergone treatment for cancer in the last year.
• Individuals who are currently an inpatient in a hospital.

Sponsors & Collaborators

• York Teaching Hospitals NHS Foundation Trust: lead
• York St John University: collaborator
• University of York: collaborator

Study Sites (1)

York and Scarborough Teaching Hospitals NHS Foundation Trust

York, North Yorkshire, YO31 8HE, United Kingdom

Location

MeSH Terms

Interventions

Exercise Test

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• John O'Rourke

  Academic Clinical Fellow

  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

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: May 6, 2024
• Study Start: April 8, 2024
• Primary Completion: October 15, 2024
• Study Completion: July 1, 2025
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)