NCT02064361

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 17, 2014

Completed
Last Updated

February 17, 2014

Status Verified

February 1, 2014

Enrollment Period

3 months

First QC Date

February 12, 2014

Last Update Submit

February 13, 2014

Conditions

Keywords

SCUBA divingexercise,microparticlesneutrophil activation,high intensity exercise

Outcome Measures

Primary Outcomes (1)

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

    Prior to exercise, prior to diving, 15 and 120 minutes after surfacing

Study Arms (1)

High intensity exercise

EXPERIMENTAL

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

Other: High intensity exercise

Interventions

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.

High intensity exercise

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • Prior incidence 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, Dalmatia, 21000, Croatia

Location

Related Publications (1)

  • 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.

    PMID: 23493363BACKGROUND

MeSH Terms

Conditions

Decompression SicknessMotor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

BarotraumaWounds and InjuriesBehavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Zeljko Dujic, MD. PhD

    University of Split

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Zeljko Dujic MD, PhD

Study Record Dates

First Submitted

February 12, 2014

First Posted

February 17, 2014

Study Start

February 1, 2013

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

February 17, 2014

Record last verified: 2014-02

Locations