NCT01893762

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 9, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

July 1, 2014

Status Verified

June 1, 2014

Enrollment Period

7 months

First QC Date

June 27, 2013

Last Update Submit

June 30, 2014

Conditions

Upper Respiratory Tract InfectionsURTI

Keywords

neutrophilexerciseURTIInnateImmune

Outcome Measures

Primary Outcomes (1)

  • 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.

    pre, 0h, 2h and 4h

Secondary Outcomes (2)

  • Functional differences of neutrophil phenotypes before versus neutrophils that appear after exercise

    pre and 2h post

  • Changes in absolute cell count

    pre, 0, 2h and 4h

Other Outcomes (1)

  • Differences between anaerobic and aerobic exercise in neutrophil surface marker expression, functionality of neutrophils and absolute cell counts (granulocytes, lymphocytes and monocytes)

    pre, 0h, 2h, 4h

Study Arms (1)

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.

Biological: Aerobic exerciseBiological: Anaerobic exercise

Interventions

Aerobic exerciseBIOLOGICAL

Aerobic exercise: 2x30 min on an indoor rowing machine at 75% of Maximum heart rate

16 rowers
Anaerobic exerciseBIOLOGICAL

Anaerobic exercise: 3x1000m maximum effort, on an indoor rowing machine

16 rowers

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Asthmatic
  • Current respiratory infection, sinusitis, otitis or any other sign of acute/ chronic inflammatory disease
  • Physically injured

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rowing Centre "De Driewerf"

Utrecht, Utrecht, 3525BB, Netherlands

Location

MeSH Terms

Conditions

Respiratory Tract InfectionsMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Bart Hilvering, M.D.

    UMC Utrecht, department of Respiratory Medicine

    STUDY DIRECTOR

  • Leo Koenderman, Professor

    UMC Utrecht, department of Respiratory Medicine

    PRINCIPAL INVESTIGATOR

  • Daan Switters

    UMC Utrecht

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

June 27, 2013

First Posted

July 9, 2013

Study Start

May 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

July 1, 2014

Record last verified: 2014-06

Locations

NL(1)