Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06400212 |
| Other study ID # |
332548Y |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 8, 2024 |
| Est. completion date |
December 2024 |
Study information
| Verified date |
May 2024 |
| Source |
York Teaching Hospitals NHS Foundation Trust |
| Contact |
Deborah Phillips |
| Phone |
07464 491875 |
| Email |
deborah.phillips23[@]nhs.net |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
