Upper Respiratory Tract InfectionsINCREASENCT01893762
Innate Immune Response to (An)Aerobic Exercise in Rowing Athletes
A study testing Aerobic exercise and Anaerobic exercise in people with Upper Respiratory Tract Infections and URTI, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper Respiratory Tract Infections, URTI
- What is being tested?
- Aerobic exercise and Anaerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2013to Dec 2013
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Asthmatic
- Current respiratory infection, sinusitis, otitis or any other sign of acute/ chronic inflammatory disease
- Physically injured
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
Study design:
Investigator driven, monocenter observational pilot study.
Study population: 16 healthy, non-asthmatic, human volunteers, 18-25 year old. All competitive rowing athletes.
Read the 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.
- Conditions
- Upper Respiratory Tract Infections, URTI
- Being tested
- Aerobic exercise, Anaerobic exercise
- Keywords
- neutrophil, exercise, URTI, Innate, Immune
- Medical subject headings
- Respiratory Tract Infections, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseBiological
Aerobic exercise: 2x30 min on an indoor rowing machine at 75% of Maximum heart rate
Anaerobic exerciseBiological
Anaerobic exercise: 3x1000m maximum effort, on an indoor rowing machine
| Study group | Role | What they receive |
|---|---|---|
| 16 rowers | Experimental | 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. Receives: Biological: Aerobic exercise; Biological: Anaerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in neutrophil surface marker expression profiles over time
FACS analysis of peripheral blood neutrophils. The changes in surface markers over time will be analysed by principal component analysis.
Measured: pre, 0h, 2h and 4h
Secondary outcomes (2)
Functional differences of neutrophil phenotypes before versus neutrophils that appear after exercise
Neutrophils: Oxidative burst, killing capacity of St. Aureus, chemotaxis
Measured: pre and 2h post
Changes in absolute cell count
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.
Measured: pre, 0, 2h and 4h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Respiratory Tract InfectionsStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, B. Hilvering, UMC Utrecht
- Investigators
- Bart Hilvering, M.D., Study director, UMC Utrecht, department of Respiratory MedicineLeo Koenderman, Professor, Principal investigator, UMC Utrecht, department of Respiratory MedicineDaan Switters, Study director, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01893762
- Sponsor's protocol ID
- INCREASE-2013
- Acronym
- INCREASE
- Status last verified
- Jun 2014
- First submitted
- 27 Jun 2013
- Last updated
- 1 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innate Immune Response to Anaerobe and Aerobe Exercise in Rowing Athletes
- ClinicalTrials.gov ID
- NCT01893762
- Acronym / sponsor ID
- INCREASE / INCREASE-2013
- Conditions
- Upper Respiratory Tract Infections, URTI
- Keywords
- neutrophil, exercise, URTI, Innate, Immune
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 9 Jul 2013 (estimated)
- 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 16 rowers | Experimental | Biological: Aerobic exercise, Biological: Anaerobic exerciseAdult 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Asthmatic
- Current respiratory infection, sinusitis, otitis or any other sign of acute/ chronic inflammatory disease
- Physically injured
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 |
|---|---|---|
| Aerobic exerciseAerobic exercise: 2x30 min on an indoor rowing machine at 75% of Maximum heart rate | Biological | 16 rowers |
| Anaerobic exerciseAnaerobic exercise: 3x1000m maximum effort, on an indoor rowing machine | Biological | 16 rowers |
Primary outcome
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.
2 secondary outcomes
Functional differences of neutrophil phenotypes before versus neutrophils that appear after exercise
Time frame: pre and 2h post
Changes in absolute cell count
Time frame: pre, 0, 2h and 4h
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 1 Jul 2014.
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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.
Bart Hilvering, M.D. study director
UMC Utrecht, department of Respiratory Medicine
Leo Koenderman, Professor principal investigator
UMC Utrecht, department of Respiratory Medicine
Daan Switters study director
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise and Anaerobic exercise in people with Upper Respiratory Tract Infections and URTI, run by UMC Utrecht at 1 site in Netherlands.
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 5 inclusion and 3 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 1 Jul 2014. 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 Netherlands. 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?
Change in neutrophil surface marker expression profiles over time (time frame: pre, 0h, 2h and 4h). 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 1 Jul 2014.