Back to resultsExercise and Repetitive Diving
Primary Purpose
Decompression Sickness, Endothelial Dysfunction, Neutrophil Activation
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Aerobic running exercise
Sponsored by
About this trial
This is an interventional basic science trial for Decompression Sickness focused on measuring SCUBA diving, Exercise, Microparticles, Repetitive diving, Endothelial function
Eligibility Criteria
Inclusion Criteria:
- Certified SCUBA diver
- Certified to dive by experienced Medical evaluator
- Must be able to run continuously for 45 min
Exclusion Criteria:
- Prior diagnosis of decompression sickness
Sites / Locations
- University of Maryland
- University of Split School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Control dives 1st
Predive exercise 1st
Arm Description
Subjects in this group complete the first 3 dives as control dives and the second 3 dives preceded by aerobic exercise
Subjects complete the first 3 dives preceded by the intervention of aerobic exercise and the second 3 with no exercise as control dives
Outcomes
Primary Outcome Measures
Change in circulating microparticle counts
Change in circulating microparticle counts measured pre and post SCUBA diving following 6 dives spaced over 12 days
Secondary Outcome Measures
Full Information
NCT ID
NCT02118207
First Posted
April 16, 2014
Last Updated
April 16, 2014
Sponsor
University Hospital of Split
Collaborators
University of Maryland
1. Study Identification
Unique Protocol Identification Number
NCT02118207
Brief Title
Exercise and Repetitive Diving
Official Title
The Impact of Predive Exercise on Repetitive SCUBA Diving
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
January 2014 (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
SCUBA diving frequently involves repetitive exposures over multiple days. The goal of this study was to see how exercise impacts microparticles (MPs), endothelial function, and venous gas emboli (VGE) over a series of dives.
16 divers in 2 groups each completed 6 dives. One group completed 3 control dives followed by 5 days rest then 3 dives preceded by exercise. The other group completed the opposite protocol. Flow-mediated dilation (FMD) data and blood for MP analysis was collected before and after each dive. VGE were monitored via transthoracic echocardiography 30, 60, and 90 min after surfacing. Exercise before diving consisted of 60 min running outdoors including 8x4 min intervals at 90% VO2max effort.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Decompression Sickness, Endothelial Dysfunction, Neutrophil Activation, Venous Gas Emboli
Keywords
SCUBA diving, Exercise, Microparticles, Repetitive diving, Endothelial function
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control dives 1st
Arm Type
Experimental
Arm Description
Subjects in this group complete the first 3 dives as control dives and the second 3 dives preceded by aerobic exercise
Arm Title
Predive exercise 1st
Arm Type
Experimental
Arm Description
Subjects complete the first 3 dives preceded by the intervention of aerobic exercise and the second 3 with no exercise as control dives
Intervention Type
Other
Intervention Name(s)
Aerobic running exercise
Intervention Description
60 min of aerobic intervals completed prior to SCUBA diving
Primary Outcome Measure Information:
Title
Change in circulating microparticle counts
Description
Change in circulating microparticle counts measured pre and post SCUBA diving following 6 dives spaced over 12 days
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Certified SCUBA diver
Certified to dive by experienced Medical evaluator
Must be able to run continuously for 45 min
Exclusion Criteria:
Prior diagnosis of decompression sickness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeljko Dujic, MD, PhD
Organizational Affiliation
University of Split, School of Medicine
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
ZIP/Postal Code
21000
Country
Croatia
12. IPD Sharing Statement
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Exercise and Repetitive Diving
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