Decompression SicknessNCT02118207
Exercise and Repetitive Diving
A study testing Aerobic running exercise in people with Decompression Sickness and Endothelial Dysfunction, run by University of Split at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Decompression Sickness, Endothelial Dysfunction, Neutrophil Activation
- What is being tested?
- Aerobic running exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2013to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Certified SCUBA diver
- Certified to dive by experienced Medical evaluator
- Must be able to run continuously for 45 min
Who cannot join
- Prior diagnosis of decompression sickness
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: The Impact of Predive Exercise on Repetitive SCUBA Diving
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.
- Being tested
- Aerobic running exercise
- Keywords
- SCUBA diving, Exercise, Microparticles, Repetitive diving, Endothelial function
- Medical subject headings
- Decompression Sickness, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic running exerciseOther
60 min of aerobic intervals completed prior to SCUBA diving
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Aerobic running exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in circulating microparticle counts
Change in circulating microparticle counts measured pre and post SCUBA diving following 6 dives spaced over 12 days
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startOct 2013
- Primary completionNov 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decompression SicknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Split
- Sponsor type
- University, hospital or other
- Collaborators
- University of Maryland
- Responsible party
- Principal investigator, Zeljko Dujic, University of Split
- Investigators
- Zeljko Dujic, MD, PhD, Principal investigator, University of Split, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02118207
- Sponsor's protocol ID
- 264816-02
- Status last verified
- Apr 2014
- First submitted
- 16 Apr 2014
- Last updated
- 21 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Predive Exercise on Repetitive SCUBA Diving
- ClinicalTrials.gov ID
- NCT02118207
- Acronym / sponsor ID
- 264816-02
- Keywords
- SCUBA diving, Exercise, Microparticles, Repetitive diving, Endothelial function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of SplitUniversity, hospital or other
- Collaborators
- University of Maryland
- Study start
- Oct 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 21 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control dives 1st | Experimental | Other: Aerobic running exerciseSubjects in this group complete the first 3 dives as control dives and the second 3 dives preceded by aerobic exercise |
| Predive exercise 1st | Experimental | Other: Aerobic running exerciseSubjects complete the first 3 dives preceded by the intervention of aerobic exercise and the second 3 with no exercise as control dives |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Certified SCUBA diver
- Certified to dive by experienced Medical evaluator
- Must be able to run continuously for 45 min
Key exclusion criteria (1 listed)
- Prior diagnosis of decompression sickness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic running exercise60 min of aerobic intervals completed prior to SCUBA diving | Other | Control dives 1st, Predive exercise 1st |
Primary outcome
Change in circulating microparticle counts
Time frame: 2 weeks
Change in circulating microparticle counts measured pre and post SCUBA diving following 6 dives spaced over 12 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeljko Dujic, MD, PhD principal investigator
University of Split, School of Medicine
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic running exercise in people with Decompression Sickness and Endothelial Dysfunction, run by University of Split at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in circulating microparticle counts (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2014.