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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02118207
Other study ID # 264816-02
Secondary ID
Status Completed
Phase N/A
First received April 16, 2014
Last updated April 16, 2014
Start date October 2013
Est. completion date January 2014

Study information

Verified date April 2014
Source University of Split
Contact n/a
Is FDA regulated No
Health authority Croatia: Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date January 2014
Est. primary completion date November 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science


Intervention

Other:
Aerobic running exercise
60 min of aerobic intervals completed prior to SCUBA diving

Locations

Country Name City State
Croatia University of Split School of Medicine Split
United States University of Maryland Baltimore Maryland

Sponsors (2)

Lead Sponsor Collaborator
University of Split University of Maryland

Countries where clinical trial is conducted

United States,  Croatia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in circulating microparticle counts Change in circulating microparticle counts measured pre and post SCUBA diving following 6 dives spaced over 12 days 2 weeks No
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