- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01893762
Innate Immune Response to (An)Aerobic Exercise in Rowing Athletes (INCREASE)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Utrecht, Netherlands, 3525BB
- Rowing Centre "De Driewerf"
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Elite rower: rowing for 12 months or longer, >6 times a week.
- Aged 18-25 years
- Pretested(by exercise test*) maximum heart rate
- Visiting Rowing club Triton, Orca or Viking
- Performed a sports medical examination test (required for competing on a national level by the Royal Dutch Rowing Asscociation) *The exercise test is a multi step power test which builds up to maximum effort.
Exclusion Criteria:
- Asthmatic
- Current respiratory infection, sinusitis, otitis or any other sign of acute/ chronic inflammatory disease
- Physically injured
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 16 rowers
Adult rowers, aged between 18 and 25, training >6 times a week are subjected to both an aerobic and a an anaerobic exercise challenge.
Between the two challenges there must a pause of at least a week.
|
Aerobic exercise: 2x30 min on an indoor rowing machine at 75% of Maximum heart rate
Anaerobic exercise: 3x1000m maximum effort, on an indoor rowing machine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in neutrophil surface marker expression profiles over time
Time Frame: pre, 0h, 2h and 4h
|
FACS analysis of peripheral blood neutrophils.
The changes in surface markers over time will be analysed by principal component analysis.
|
pre, 0h, 2h and 4h
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional differences of neutrophil phenotypes before versus neutrophils that appear after exercise
Time Frame: pre and 2h post
|
Neutrophils: Oxidative burst, killing capacity of St. Aureus, chemotaxis
|
pre and 2h post
|
Changes in absolute cell count
Time Frame: pre, 0, 2h and 4h
|
Measuring the change in absolute cell count (granulocytes, lymphocytes, monocytes) over time.
Timepoint 'pre' is considered to be the basal level and 0, 2 and 4h as points of change.
Repeated measures ANOVA will be used to detect the change.
|
pre, 0, 2h and 4h
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Differences between anaerobic and aerobic exercise in neutrophil surface marker expression, functionality of neutrophils and absolute cell counts (granulocytes, lymphocytes and monocytes)
Time Frame: pre, 0h, 2h, 4h
|
Compare the peripheral blood leukocyte characteristics in the context of anaerobic versus aerobic exercise challenge
|
pre, 0h, 2h, 4h
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Bart Hilvering, M.D., UMC Utrecht, department of Respiratory Medicine
- Principal Investigator: Leo Koenderman, Professor, UMC Utrecht, department of Respiratory Medicine
- Study Director: Daan Switters, UMC Utrecht
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- INCREASE-2013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Upper Respiratory Tract Infections
-
University of WashingtonNational Center for Complementary and Integrative Health (NCCIH)WithdrawnUpper Respiratory Infections
-
University of UtahCompletedUpper Respiratory Infections
-
NovartisNovartis Consumer HealthCompleted
-
Stephen J. Teach, MD, MPHNational Institute of Allergy and Infectious Diseases (NIAID)RecruitingAsthma in Children | Atopy | Viral Upper Respiratory InfectionUnited States
-
BioHealth Technologies Inc.CompletedUpper Respiratory InfectionsUnited States
-
Thomas ErbCompletedUpper Respiratory InfectionsSwitzerland
-
Société des Produits Nestlé (SPN)Completed
-
The Archer-Daniels-Midland CompanyAtlantia Food Clinical TrialsRecruitingUpper Respiratory Tract Infections | Upper Resp Tract InfectionIreland
-
Valenta Pharm JSCCompletedInfluenza | Viral Respiratory Infection | Acute Viral Upper Respiratory InfectionsRussian Federation
Clinical Trials on Aerobic exercise
-
Riphah International UniversityCompleted
-
Sultan Abdulhamid Han Training and Research Hospital...RecruitingPhysical InactivityTurkey
-
University of FloridaAmerican Psychological Foundation; Clinical & Translational Science Institute; American Psychological Association (APA)CompletedBrain ConcussionUnited States
-
Radboud University Medical CenterUniversity Hospital, Bonn; University of Dublin, Trinity College; German Sport... and other collaboratorsCompletedMild Cognitive ImpairmentNetherlands, Ireland, Germany
-
University of PittsburghNational Heart, Lung, and Blood Institute (NHLBI)TerminatedChildhood ObesityUnited States
-
National Yang Ming UniversityUnknownKnee OsteoarthritisTaiwan
-
National Defense Medical Center, TaiwanMinistry of Science and Technology, TaiwanRecruitingCardiology | PsychiatryTaiwan
-
RenJi HospitalNot yet recruitingST-segment Elevation Myocardial Infarction (STEMI)
-
Federal University of PelotasMinistry of Health, BrazilUnknownHypertension | Cardiovascular Disease | Chronic Kidney Disease | Chronic Renal DiseaseBrazil
-
University of Kansas Medical CenterRecruiting