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

Primary Purpose

Decompression Sickness, SCUBA Diving

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
High intensity exercise
Sponsored by
University Hospital of Split
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Decompression Sickness focused on measuring SCUBA diving, exercise,, microparticles, neutrophil activation,, high intensity exercise

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Prior incidence of decompression sickness

Sites / Locations

  • University of Maryland
  • University of Split School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

High intensity exercise

Arm Description

A dive to 18 meters sea water for a duration of 41 minutes preceded by high intensity cycling

Outcomes

Primary Outcome Measures

Change from baseline values of number of circulating microparticles per microliter of blood

Secondary Outcome Measures

Full Information

First Posted
February 12, 2014
Last Updated
February 13, 2014
Sponsor
University Hospital of Split
Collaborators
University of Maryland
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1. Study Identification

Unique Protocol Identification Number
NCT02064361
Brief Title
High Intensity Cycling Before SCUBA Diving Reduces Post-decompression Microparticle Production and Neutrophil Activation
Official Title
High Intensity Cycling Before SCUBA Diving Reduces Post-decompression Microparticle Production and Neutrophil Activation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital of Split
Collaborators
University of Maryland

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Decompression Sickness, SCUBA Diving
Keywords
SCUBA diving, exercise,, microparticles, neutrophil activation,, high intensity exercise

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High intensity exercise
Arm Type
Experimental
Arm Description
A dive to 18 meters sea water for a duration of 41 minutes preceded by high intensity cycling
Intervention Type
Other
Intervention Name(s)
High intensity exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Experienced divers (> 250 logged dives) Male Physician clearance to dive Exclusion Criteria: Prior incidence of decompression sickness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeljko Dujic, MD. PhD
Organizational Affiliation
University Hospital of Split
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
University of Split School of Medicine
City
Split
State/Province
Dalmatia
ZIP/Postal Code
21000
Country
Croatia

12. IPD Sharing Statement

Citations:
PubMed Identifier
23493363
Citation
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.
Results Reference
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High Intensity Cycling Before SCUBA Diving Reduces Post-decompression Microparticle Production and Neutrophil Activation

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