Upper Respiratory Tract Infections Clinical Trial
Official title:
Innate Immune Response to Anaerobe and Aerobe Exercise in Rowing Athletes
Exercise induces innate immune response activation in athletes. The response starts during
exercise and lasts for approximately 24 hours. This innate immune response shows
similarities to the innate immune activation observed in, for example, bacterial infection
and trauma. Immediately after exercise, athletes develop leukocytosis and cytokine
production is altered towards an inflammatory pattern. However, to gain insight in immune
response, a detailed cell receptor expression is required. To investigate the physiological
innate immune response to exercise, we developed a model in rowers.
Aim: To determine the type and degree of cellular inflammatory response in peripheral blood
of elite rowing athletes after both anaerobe and aerobe exercise.
Study design:
Investigator driven, monocenter observational pilot study.
Study population: 16 healthy, non-asthmatic, human volunteers, 18-25 year old. All
competitive rowing athletes.
Rationale: Exercise induces innate immune response activation in athletes. The response
starts during exercise and lasts for approximately 24 hours. This innate immune response
shows similarities to the innate immune activation observed in, for example, bacterial
infection and trauma. Immediately after exercise, athletes develop leukocytosis and cytokine
production is altered towards an inflammatory pattern. However, to gain insight in immune
response, a detailed cell receptor expression is required. To investigate the physiological
innate immune response to exercise, we developed a model in rowers.
Objective: To determine the type and degree of cellular inflammatory response in peripheral
blood of elite rowing athletes after both anaerobe and aerobe exercise.
Study design: Investigator driven, monocenter observational pilot study.
Study population: 16 healthy, non-asthmatic, human volunteers, 18-25 year old. All
competitive rowing athletes.
Intervention : All athletes perform two separate tests on a rowing ergometer. One anaerobe
(flat out) exercise test (minutes) at day 1 and a aerobe test (1 hour) at day 2. Blood
withdrawal of 9mL will be performed at four time points (1 pretest time point and 3 post: at
0h, 2 and 4h).
Main study parameters/endpoints: The main endpoint is a rise in neutrophil cell count and
the appearance of different subsets of neutrophils objectified by a change in receptor
expression. Not only neutrophils are important in this innate cell response, other
leukocytes like lymphocytes, monocytes and hematopoietic progenitor cells also play a role.
Therefore the detailed analysis of receptor profiles on these cells will be measured by
Flowcytometry.
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness: The anaerobe and aerobe exercise tests do not differ significantly from what
the athletes are used to do for training purposes. Athletes who experience any pain or
discomfort during exercise will be advised to stop. Blood withdrawal on itself may cause a
vasovagal response and especially well trained athletes are susceptible to develop this
response. A trained physician is present to take care and look after rowers that suffered
from vasovagal collapse. All anaerobe exercise brings along a very small risk of acute
cardiovascular complications and although all rowers undergo exercise testing by an exercise
physiologist before participating in competition, this risk remains.
The total amount of time of the study is 2 times 5 hours. This time frame consists of the
prior blood withdrawal, the testing itself and subsequently the three time points of blood
withdrawal. The amount of blood withdrawal per athlete is 4 x 9mL, with a total of 36 mL per
volunteer at one day of testing. The total blood withdrawal is therefore 72 mL base on two
testing days.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01158560 -
A Trial of Vitamin D and Health Advice for the Prevention of Upper Respiratory Tract Infections
|
Phase 3 | |
Completed |
NCT00965822 -
A Randomized, Double-blind, Placebo-controlled Study on the Efficacy and Safety of CVT-E002 in the Treatment of Upper Respiratory Tract Infections in a Pediatric (3-11 Years) Population
|
Phase 2 | |
Completed |
NCT01019889 -
Effect of Socheongryong-tang and Yeongyopaedok-san in Upper Respiratory Tract Infection
|
Phase 3 | |
Not yet recruiting |
NCT05484102 -
Preventive Effect of Cow's Milk Fermented With Lactobacillus Paracasei CBA L74 on Common Infectious Diseases in Children
|
N/A | |
Recruiting |
NCT05804123 -
LiveSpo Navax® Supports the Treatment of Acute Rhinosinusitis and Otitis Media
|
N/A | |
Completed |
NCT01773824 -
Routine Prescription Feedback and Peer Comparison to Lower Antibiotic Prescriptions in Primary Care
|
N/A | |
Terminated |
NCT01964885 -
Benefit and Tolerability of IQP-AS-105 in Reducing Susceptibility to Upper Respiratory Tract Infections
|
Phase 3 | |
Completed |
NCT01883427 -
Nasal Spray With Glucose Oxidase Preventing Common Cold in Pre-school Children
|
Phase 2 | |
Completed |
NCT01215682 -
Vitamin D Supplementation and Upper Respiratory Tract Infections in Adolescent Swimmers
|
N/A | |
Completed |
NCT04019730 -
The Effect of a Ketogenic Diet on the Exercise Induced Immune Response
|
N/A | |
Completed |
NCT01604096 -
Controlled Trial to Evaluate a Local Information Campaign on Antibiotic Prescribing in Italy
|
Phase 2 | |
Recruiting |
NCT06149494 -
RCT of Vapendavir in Patients With COPD and Human Rhinovirus/Enterovirus Upper Respiratory Infection
|
Phase 2 | |
Completed |
NCT03463694 -
Edinburgh and Lothian Virus Intervention Study in Kids
|
N/A | |
Completed |
NCT06127186 -
Phenotype of Headache and Facial Pain in Upper Respiratory Tract Infections
|
||
Completed |
NCT03198676 -
A Safety Study to Compare the Effect of Two PrEP-001 Nasal Powder Formulations on Nasal Mucosa and Serum Cytokine Production
|
Phase 1 | |
Withdrawn |
NCT05557214 -
Reducing Unnecessary Antibiotic Prescriptions in Primary Healthcare in Saskatchewan by Identifying High Prescribers
|
N/A | |
Completed |
NCT01129128 -
Three Arm Trial of Immune Effects of Echinacea
|
N/A | |
Completed |
NCT01396889 -
Impact of Echinacea as Prophilaxis for Upper Respiratory Tract Infections in Children 1-5 Years
|
N/A | |
Completed |
NCT05252468 -
COVID-19 Prevention Trial: Effect of Prophylactic Use of TAFFIX™ on Infection Rate by SARS-CoV-2 Virus (COVID-19).
|
N/A | |
Terminated |
NCT05279534 -
Efficacy and Safety of L. Plantarum and P. Acidilactici in Children With Upper Respiratory Tract Infections
|
N/A |