High Intensity Cycling Before SCUBA Diving Reduces Post-decompression Microparticle Production and Neutrophil Activation
High Intensity Cycling Before SCUBA Diving Reduces Post-decompression Microparticle Production and Neutrophil Activation
Sponsors
Source
University Hospital of Split
Oversight Info
Has Dmc
No
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.
Overall Status
Completed
Start Date
2013-02-01
Completion Date
2013-05-01
Primary Completion Date
2013-05-01
Phase
N/A
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
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 |
Enrollment
10
Conditions
Intervention
Intervention Type
Other
Intervention Name
Description
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.
Arm Group Label
High intensity exercise
Eligibility
Criteria
Inclusion Criteria:
- Experienced divers (> 250 logged dives)
- Male
- Physician clearance to dive
Exclusion Criteria:
- Prior incidence of decompression sickness
Gender
Male
Minimum Age
18 Years
Maximum Age
65 Years
Healthy Volunteers
Accepts Healthy Volunteers
Overall Official
Last Name |
Role |
Affiliation |
|
Zeljko Dujic, MD. PhD |
Principal Investigator |
University Hospital of Split |
Location
Facility |
|
University of Maryland Baltimore Maryland 21201 United States |
|
University of Split School of Medicine Split Dalmatia 21000 Croatia |
Location Countries
Country
Croatia
United States
Verification Date
2014-02-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
University Hospital of Split
Investigator Full Name
Zeljko Dujic
Investigator Title
Professor Zeljko Dujic MD, PhD
Keywords
Has Expanded Access
No
Condition Browse
Number Of Arms
1
Arm Group
Arm Group Label
High intensity exercise
Arm Group Type
Experimental
Description
A dive to 18 meters sea water for a duration of 41 minutes preceded by high intensity cycling
Firstreceived Results Date
N/A
Reference
Citation
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
23493363
Firstreceived Results Disposition Date
N/A
Study Design Info
Intervention Model
Single Group Assignment
Primary Purpose
Basic Science
Masking
None (Open Label)
Study First Submitted
February 12, 2014
Study First Submitted Qc
February 13, 2014
Study First Posted
February 17, 2014
Last Update Submitted
February 13, 2014
Last Update Submitted Qc
February 13, 2014
Last Update Posted
February 17, 2014
ClinicalTrials.gov processed this data on December 13, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.