NCT02118207

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.

Trial Health

90
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 Oct 2013

Shorter than P25 for not_applicable

Geographic Reach
2 countries

2 active sites

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

October 1, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2014

Completed
Last Updated

April 21, 2014

Status Verified

April 1, 2014

Enrollment Period

1 month

First QC Date

April 16, 2014

Last Update Submit

April 16, 2014

Conditions

Keywords

SCUBA divingExerciseMicroparticlesRepetitive divingEndothelial function

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Control dives 1st

EXPERIMENTAL

Subjects in this group complete the first 3 dives as control dives and the second 3 dives preceded by aerobic exercise

Other: Aerobic running exercise

Predive exercise 1st

EXPERIMENTAL

Subjects complete the first 3 dives preceded by the intervention of aerobic exercise and the second 3 with no exercise as control dives

Other: Aerobic running exercise

Interventions

60 min of aerobic intervals completed prior to SCUBA diving

Control dives 1stPredive exercise 1st

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Certified SCUBA diver
  • Certified to dive by experienced Medical evaluator
  • Must be able to run continuously for 45 min

You may not qualify if:

  • Prior diagnosis of decompression sickness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Maryland

Baltimore, Maryland, 21201, United States

Location

University of Split School of Medicine

Split, 21000, Croatia

Location

MeSH Terms

Conditions

Decompression SicknessMotor Activity

Condition Hierarchy (Ancestors)

BarotraumaWounds and InjuriesBehavior

Study Officials

  • Zeljko Dujic, MD, PhD

    University of Split, School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Zeljko Dujic MD, PhD, Director of Department of Physiology

Study Record Dates

First Submitted

April 16, 2014

First Posted

April 21, 2014

Study Start

October 1, 2013

Primary Completion

November 1, 2013

Study Completion

January 1, 2014

Last Updated

April 21, 2014

Record last verified: 2014-04

Locations