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High Intensity Cycling Before SCUBA Diving Reduces Post-decompression Microparticle Production and Neutrophil Activation

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ClinicalTrials.gov Identifier: NCT02064361
Recruitment Status : Completed
First Posted : February 17, 2014
Last Update Posted : February 17, 2014
Sponsor:
Collaborator:
University of Maryland, College Park
Information provided by (Responsible Party):
Zeljko Dujic, University Hospital of Split

Tracking Information
First Submitted Date  ICMJE February 12, 2014
First Posted Date  ICMJE February 17, 2014
Last Update Posted Date February 17, 2014
Study Start Date  ICMJE February 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2014)
Change from baseline values of number of circulating microparticles per microliter of blood [ Time Frame: Prior to exercise, prior to diving, 15 and 120 minutes after surfacing ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE High Intensity Cycling Before SCUBA Diving Reduces Post-decompression Microparticle Production and Neutrophil Activation
Official Title  ICMJE High Intensity Cycling Before SCUBA Diving Reduces Post-decompression Microparticle Production and Neutrophil Activation
Brief Summary The purpose of this study is to determine the impact of high intensity,anaerobic exercise, in the form of cycling, on SCUBA diving. Outcomes are determined by the quantification and subtype of circulating microparticles, complete blood counts, and the quantification of venous gas emboli, measured via transthoracic echocardiography, in the cardiac cavities.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Decompression Sickness
  • SCUBA Diving
Intervention  ICMJE Other: High intensity exercise
Subjects performed a repeated Wingate protocol for the exercise condition of the study. This consisted of 4, 30 s maximal efforts on a weight-braked cycle ergometer (Monark 894E, Monark Exercise AB, Sweden) with 4 min active recovery between efforts, preceded by a 5 min warm up. The resistance was set at 7.5% bodyweight for the intervals and 2% for the warm up and active recovery periods.
Study Arms  ICMJE Experimental: High intensity exercise
A dive to 18 meters sea water for a duration of 41 minutes preceded by high intensity cycling
Intervention: Other: High intensity exercise
Publications * Thom SR, Milovanova TN, Bogush M, Yang M, Bhopale VM, Pollock NW, Ljubkovic M, Denoble P, Madden D, Lozo M, Dujic Z. Bubbles, microparticles, and neutrophil activation: changes with exercise level and breathing gas during open-water SCUBA diving. J Appl Physiol (1985). 2013 May 15;114(10):1396-405. doi: 10.1152/japplphysiol.00106.2013. Epub 2013 Mar 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 13, 2014)
10
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Experienced divers (> 250 logged dives)
  • Male
  • Physician clearance to dive

Exclusion Criteria:

  • Prior incidence of decompression sickness
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Croatia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02064361
Other Study ID Numbers  ICMJE SCUBACYC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Zeljko Dujic, University Hospital of Split
Study Sponsor  ICMJE University Hospital of Split
Collaborators  ICMJE University of Maryland, College Park
Investigators  ICMJE
Principal Investigator: Zeljko Dujic, MD. PhD University Hospital of Split
PRS Account University Hospital of Split
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP