Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02064361
Other study ID # SCUBACYC
Secondary ID
Status Completed
Phase N/A
First received February 12, 2014
Last updated February 13, 2014
Start date February 2013
Est. completion date May 2013

Study information

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

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date May 2013
Est. primary completion date May 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Experienced divers (> 250 logged dives)

- Male

- Physician clearance to dive

Exclusion Criteria:

- Prior incidence of decompression sickness

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Other:
High intensity exercise
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.

Locations

Country Name City State
Croatia University of Split School of Medicine Split Dalmatia
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, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
See also
  Status Clinical Trial Phase
Completed NCT02118207 - Exercise and Repetitive Diving N/A
Completed NCT02432131 - Decompression Sickness in Divers With or Without Patent Foramen Ovale
Completed NCT02468752 - Reduction of Venous Emboli Load After Breathing Normobaric Oxygen Compared to Air Phase 2/Phase 3
Recruiting NCT03192956 - Markers of Central Nervous System Injury in Decompression Sickness
Recruiting NCT04791488 - Impact of Hyperoxia and Involvement of the Immune System in Diving Accident N/A
Completed NCT02736006 - Decreases in Diffusing Lung Capacity for Carbon Monoxide (DLCO) in Occupational Divers and Their Impact on Decompression Sickness Risks N/A
Not yet recruiting NCT06370897 - Prediction & Mechanisms of Recovery Following IEDS
Not yet recruiting NCT06216366 - Rhu-pGSN to Mitigate Proinflammatory Responses to Decompression in Healthy SCUBA Divers Phase 2
Enrolling by invitation NCT02483650 - Hyperbaric Oxygen Therapy Registry
Completed NCT03390335 - Decompression Tables for Diving at Altitude N/A
Completed NCT01587209 - Microparticles in Scuba Divers With Decompression Sickness N/A