Inflammatory ResponseCytoHealthNCT06400212
CytoHealth - A Study of the Inflammatory Response to Exercise
A study testing Cardiopulmonary exercise test in people with Inflammatory Response and Immune System, run by York Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Response, Immune System
- What is being tested?
- Cardiopulmonary exercise test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Apr 2024to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Any individual between the ages of 18 and 60 who has appropriately consented to take part in the study and who does not fulfil any of the 10 exclusion criteria.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
York and Scarborough Teaching Hospitals NHS Foundation Trust
York, North Yorkshire, YO31 8HE
About this study
Official title: CytoHealth - A Pilot Study of the Phenotypes of the Inflammatory Response to Maximal Exercise.
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.
Read the detailed description
Using blood tests, the researchers can look at different markers of inflammation circulating in the body. These markers are called cytokines and chemokines. There are many different types of cytokines and chemokines, some of which have been shown to be elevated or lowered in certain medical conditions. A number of them have been shown in studies to be elevated when the body is under stress. One way in which the body can be stressed is through strenuous exercise. The researchers want to understand what happens to cytokine and chemokine release when the participants undertake strenuous exercise in a controlled environment, and in particular the researchers want to measure how the lungs and cardiovascular system are performing and relate that to the markers in the participants blood. By measuring these together, the researchers can better understand how the body's inflammation may be affected by stress and physical fitness.
Ultimately, this information can then be used to inform research looking at patients undergoing surgery. Having a big operation is known to stress the body and the researchers know how well people do after these operations is related to how effectively their lungs and cardiovascular system work prior to the operation (how physically fit they are). What is not clear is what happens to cytokines and chemokines during and after a big operation. The researchers think that higher levels of these markers may be present if someone has lower levels of fitness, and that this would also result in them not doing as well after the operation, but the researchers do not have any studies linking this all together. CytoHealth is a key component of answering this big question as it will provide data on healthy people which the researchers can then use to guide research on patients undergoing surgery.
This study involves recruiting 40 volunteers from the general population from a range of age groups, between aged 18 and 60. In this 40 people the researchers need 20 males and 20 females. In each of these groups of 20 the researchers need 10 to be physically active and 10 to be less physically active. The reason for this categorisation is because existing research in this area is done almost solely in physically active men, and the researchers want our study to be more representative of the general population. Each participant will have to undergo a blood test before and after they exercise to measure their cytokines and chemokines. The exercise will involve a number of monitoring devices to assess how the participant's heart and lungs are functioning during the exercise. Participants involvement in the study concludes once the blood test after exercise is taken. The blood tests taken will go to a specialist laboratory where they will be processed, and the levels variety of cytokines and chemokines will be looked at. This study is a pilot study as there is very limited existing data in this area. This means the researchers are not specifically assessing one particular thing and testing if works or not. Rather the researchers are looking at general trends in the data to provide a basis for further research and importantly, seeing if doing this type of research provides us with scientifically useful information.
The process for the research participant will start with recruitment, which will be done through email communication and posters distributed to staff and students at two universities as well as staff at a large NHS hospital. Individuals who are interested in volunteering will be asked to complete a screening questionnaire which asks their age, sex, physical fitness level and some basic questions about their health. The information from this screening questionnaire can be used to identify the right number people from the groups described above. This questionnaire also outlines what the study involves. Those who are eligible will then be asked to book a slot at the exercise laboratory to attend and take part in the study. They will also be sent a full participant information booklet that will detail what exactly happens in the study.
Once a participant attends on the day they will have to go through a health questionnaire to check they are definitely eligible. They will then go through the study information again with a researcher and if they are happy to proceed, they will be asked to sign a consent form. Once they have consented they are then officially included within the study. At this point they will be allocated a participant identification number (PIN) which will be linked to their identity on a secure spreadsheet which is separate from all data collection. From this point onwards in the study, their data will only be linked to the PIN.
The weight and height of the participant will be recorded, and they will have a blood test taken from their arm. Once this is done they will be asked to sit on the stationary bike. This where they will be connected to an electrocardiogram, a blood pressure cuff, an oxygen saturation probe, a face mask and a finger probe that measures how well the heart is beating, known as a ClearSight finger probe. The face mask is standard monitor used in exercise testing that measures how much oxygen and carbon dioxide is going in and out of the lungs. The participant will then be asked to start pedalling on the bike, which at this point will not be giving any resistance. After a few minutes, a standard programme of increasing resistance is started, such that the participant has to work harder and harder. The aim is to get them to work as hard as they possibly can within about 10 minutes. It is vitally important that the participant does reach the point of exhaustion, or very close to it. Once they reach this point the bike resistance will reduce back down to nothing and the participant will have a few minutes pedalling like this to 'cool down'. They will then be disconnected from the monitoring and a second blood test will be taken.
Once this blood test is done, the participant will be checked to ensure they have appropriately recovered from the exercise and are safe to leave the study. All participants will be given an online shopping voucher worth £50 to compensate them for their time, travel costs and for participating in the study.
- Conditions
- Inflammatory Response, Immune System
- Being tested
- Cardiopulmonary exercise test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiopulmonary exercise testOther
Participants undergo a cardiopulmonary exercise test following a standardised protocol used in national guidelines
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Cardiopulmonary Exercise Testing Receives: Other: Cardiopulmonary exercise test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Sample taken immediately prior and immediately after exercise testing
Secondary outcomes (7)
VO2 (oxygen consumption of participant during exercise)
Measured in ml/kg/min using gas analysis which is connected to participant via a face mask
Measured: Data measured continuously during exercise testing (average duration of exercise test is 20 minutes)
VCO2 (carbon dioxide exhaled by participant during exercise)
Measured in ml/kg/min using gas analysis which is connected to participant via a face mask
Measured: Data measured continuously during exercise testing (average duration of exercise test is 20 minutes)
Heart rate including maximum heart rate
Measured using electrocardiogram in beats per minute (BPM)
Measured: 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
No units as ratio.
Measured: Data measured continuously during exercise testing (average duration of exercise test is 20 minutes)
Anaerobic threshold
Determined by the v-slope method of graphically comparing VO2 with VCO2 with the units being ml/kg/min
Measured: Data measured continuously during exercise testing (average duration of exercise test is 20 minutes)
Stroke volume
Determined by ClearSight finger cuff monitor with the unit mls
Measured: Data taken during exercise testing at 20 second intervals (average duration of exercise test is 20 minutes)
Borg rate of perceived exertion (RPE)
Participant asked to rate level of exertion at end of test using rate of perceived exertion scale (1-10).
Measured: Immediately at end of exercise test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start8 Apr 2024
- Primary completion15 Oct 2024
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory ResponseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- York Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- York St John University, University of York
- Responsible party
- Sponsor
- Investigators
- John O'Rourke, Principal investigator, Academic Clinical Fellow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06400212
- Sponsor's protocol ID
- 332548Y
- Acronym
- CytoHealth
- Status last verified
- Jul 2025
- First submitted
- 17 Apr 2024
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CytoHealth - A Pilot Study of the Phenotypes of the Inflammatory Response to Maximal Exercise.
- ClinicalTrials.gov ID
- NCT06400212
- Acronym / sponsor ID
- CytoHealth / 332548Y
- Conditions
- Inflammatory Response, Immune System
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- York Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- York St John University, University of York
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 6 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Using blood tests, the researchers can look at different markers of inflammation circulating in the body. These markers are called cytokines and chemokines. There are many different types of cytokines and chemokines, some of which have been shown to be elevated or lowered in certain medical conditions. A number of them have been shown in studies to be elevated when the body is under stress. One way in which the body can be stressed is through strenuous exercise. The researchers want to understand what happens to cytokine and chemokine release when the participants undertake strenuous exercise in a controlled environment, and in particular the researchers want to measure how the lungs and cardiovascular system are performing and relate that to the markers in the participants blood. By measuring these together, the researchers can better understand how the body's inflammation may be affected by stress and physical fitness.
Ultimately, this information can then be used to inform research looking at patients undergoing surgery. Having a big operation is known to stress the body and the researchers know how well people do after these operations is related to how effectively their lungs and cardiovascular system work prior to the operation (how physically fit they are). What is not clear is what happens to cytokines and chemokines during and after a big operation. The researchers think that higher levels of these markers may be present if someone has lower levels of fitness, and that this would also result in them not doing as well after the operation, but the researchers do not have any studies linking this all together. CytoHealth is a key component of answering this big question as it will provide data on healthy people which the researchers can then use to guide research on patients undergoing surgery.
This study involves recruiting 40 volunteers from the general population from a range of age groups, between aged 18 and 60. In this 40 people the researchers need 20 males and 20 females. In each of these groups of 20 the researchers need 10 to be physically active and 10 to be less physically active. The reason for this categorisation is because existing research in this area is done almost solely in physically active men, and the researchers want our study to be more representative of the general population. Each participant will have to undergo a blood test before and after they exercise to measure their cytokines and chemokines. The exercise will involve a number of monitoring devices to assess how the participant's heart and lungs are functioning during the exercise. Participants involvement in the study concludes once the blood test after exercise is taken. The blood tests taken will go to a specialist laboratory where they will be processed, and the levels variety of cytokines and chemokines will be looked at. This study is a pilot study as there is very limited existing data in this area. This means the researchers are not specifically assessing one particular thing and testing if works or not. Rather the researchers are looking at general trends in the data to provide a basis for further research and importantly, seeing if doing this type of research provides us with scientifically useful information.
The process for the research participant will start with recruitment, which will be done through email communication and posters distributed to staff and students at two universities as well as staff at a large NHS hospital. Individuals who are interested in volunteering will be asked to complete a screening questionnaire which asks their age, sex, physical fitness level and some basic questions about their health. The information from this screening questionnaire can be used to identify the right number people from the groups described above. This questionnaire also outlines what the study involves. Those who are eligible will then be asked to book a slot at the exercise laboratory to attend and take part in the study. They will also be sent a full participant information booklet that will detail what exactly happens in the study.
Once a participant attends on the day they will have to go through a health questionnaire to check they are definitely eligible. They will then go through the study information again with a researcher and if they are happy to proceed, they will be asked to sign a consent form. Once they have consented they are then officially included within the study. At this point they will be allocated a participant identification number (PIN) which will be linked to their identity on a secure spreadsheet which is separate from all data collection. From this point onwards in the study, their data will only be linked to the PIN.
The weight and height of the participant will be recorded, and they will have a blood test taken from their arm. Once this is done they will be asked to sit on the stationary bike. This where they will be connected to an electrocardiogram, a blood pressure cuff, an oxygen saturation probe, a face mask and a finger probe that measures how well the heart is beating, known as a ClearSight finger probe. The face mask is standard monitor used in exercise testing that measures how much oxygen and carbon dioxide is going in and out of the lungs. The participant will then be asked to start pedalling on the bike, which at this point will not be giving any resistance. After a few minutes, a standard programme of increasing resistance is started, such that the participant has to work harder and harder. The aim is to get them to work as hard as they possibly can within about 10 minutes. It is vitally important that the participant does reach the point of exhaustion, or very close to it. Once they reach this point the bike resistance will reduce back down to nothing and the participant will have a few minutes pedalling like this to 'cool down'. They will then be disconnected from the monitoring and a second blood test will be taken.
Once this blood test is done, the participant will be checked to ensure they have appropriately recovered from the exercise and are safe to leave the study. All participants will be given an online shopping voucher worth £50 to compensate them for their time, travel costs and for participating in the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Cardiopulmonary exercise testCardiopulmonary Exercise Testing |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Any individual between the ages of 18 and 60 who has appropriately consented to take part in the study and who does not fulfil any of the 10 exclusion criteria.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiopulmonary exercise testParticipants undergo a cardiopulmonary exercise test following a standardised protocol used in national guidelines | Other | Intervention |
Primary outcome
Serum cytokines
Time frame: Sample taken immediately prior and immediately after exercise testing
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
7 secondary outcomes
VO2 (oxygen consumption of participant during exercise)
Time frame: Data measured continuously during exercise testing (average duration of exercise test is 20 minutes)
VCO2 (carbon dioxide exhaled by participant during exercise)
Time frame: Data measured continuously during exercise testing (average duration of exercise test is 20 minutes)
Heart rate including maximum heart rate
Time frame: 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
Time frame: Data measured continuously during exercise testing (average duration of exercise test is 20 minutes)
Anaerobic threshold
Time frame: Data measured continuously during exercise testing (average duration of exercise test is 20 minutes)
Stroke volume
Time frame: Data taken during exercise testing at 20 second intervals (average duration of exercise test is 20 minutes)
Borg rate of perceived exertion (RPE)
Time frame: Immediately at end of exercise test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John O'Rourke principal investigator
Academic Clinical Fellow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiopulmonary exercise test in people with Inflammatory Response and Immune System, run by York Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum cytokines (time frame: Sample taken immediately prior and immediately after exercise testing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.