Autonomic DysfunctionPACANCT01249248
PD2i Analysis of Heart Rate Variability in Competitive Sports
An observational study of Autonomic Dysfunction, run by University of Mississippi Medical Center at 1 site in United States.
Trial summary
This is a double blind observational analysis of changes in heart rate variability using PD2i analyser in competitive athletes during strenuous exercise and competition. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Autonomic Dysfunction
- What is being tested?
- PD2i Analyzer
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Jul 2011
- Phase
- Observational
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: College athletes on competitive teams.
Who may be able to join
- Age >18 years, as determined by birth date given on participation form.
- Actively involved in competitive athletics
- Able to give informed consent
Who cannot join
- Any known prior autonomic dysfunction
- History of seizures or taking anti-seizure medication
- Known learning disability or attention deficit disorder
- Chronic heart conditions such as arrhythmias or valvular disease
- History of diabetes mellitus
- Taking any prescription stimulants such as Ritalin, Focalin, etc.
- Use of any performance-enhancing drugs
- Any deviation from normal found on the pre-participation physical exam such as the presence of a murmur or hypertension.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Mississippi Medical Center
Jackson, Mississippi, 39216
About this study
This is a double blind observational analysis of changes in heart rate variability using PD2i analyser in competitive athletes during strenuous exercise and competition.
- Conditions
- Autonomic Dysfunction
- Being tested
- PD2i Analyzer
- Keywords
- Heart rate variability, Autonomic dysfunction, Exercise, Sports, Competition, Athletes
- Medical subject headings
- Primary Dysautonomias, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD2i AnalyzerDevice
Analysis of heart rate variability from a standard digital ECG for 6-12 minutes
| Study group | Role | What they receive |
|---|---|---|
| Male basketball players | Not described Receives: Device: PD2i Analyzer | |
| Female basketball players | Not described Receives: Device: PD2i Analyzer | |
| Baseball players | Not described Receives: Device: PD2i Analyzer | |
| Softball players | Not described Receives: Device: PD2i Analyzer | |
| Football players | Not described Receives: Device: PD2i Analyzer | |
| Female vollyball players | Not described Receives: Device: PD2i Analyzer | |
| Male soccer players | Not described Receives: Device: PD2i Analyzer | |
| Female soccer players | Not described Receives: Device: PD2i Analyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PD2i following strenuous exercise bout of 45 minutes
PD2i analysis of HRV measured before and after strenuous exercise in each sport. The change from baseline will be correlated to return to resting heart rate.
Measured: Baseline at zero minutes and within 60 minutes of completion of strenuous exercise bout.
Secondary outcomes (1)
Change in PD2i following an injury during competitive sports.
If an athlete participating in the research sustains an injury the PD2i analysis will be obtained and correlated to the baseline analysis.
Measured: Baseline PD2i at zero and within 60 minutes of cessation of exercise bout.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionNov 2010
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autonomic DysfunctionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Vicor Technologies, Inc.
- Responsible party
- Principal investigator, James Hughes, University of Mississippi Medical Center
- Investigators
- Steve A Watts, MD, Principal investigator, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01249248
- Sponsor's protocol ID
- 2010-0158
- Acronym
- PACA
- Status last verified
- Apr 2012
- First submitted
- 24 Nov 2010
- Last updated
- 12 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PD2i Analysis of Heart Rate Variability in Competitive Sports
- ClinicalTrials.gov ID
- NCT01249248
- Acronym / sponsor ID
- PACA / 2010-0158
- Conditions
- Autonomic Dysfunction
- Keywords
- Heart rate variability, Autonomic dysfunction, Exercise, Sports, Competition, Athletes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Collaborators
- Vicor Technologies, Inc.
- Study start
- Oct 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 29 Nov 2010 (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.
This is a double blind observational analysis of changes in heart rate variability using PD2i analyser in competitive athletes during strenuous exercise and competition.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Male basketball players | – | Device: PD2i Analyzer |
| Female basketball players | – | Device: PD2i Analyzer |
| Baseball players | – | Device: PD2i Analyzer |
| Softball players | – | Device: PD2i Analyzer |
| Football players | – | Device: PD2i Analyzer |
| Female vollyball players | – | Device: PD2i Analyzer |
| Male soccer players | – | Device: PD2i Analyzer |
| Female soccer players | – | Device: PD2i Analyzer |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- College athletes on competitive teams.
Key inclusion criteria (3 listed)
- Age >18 years, as determined by birth date given on participation form.
- Actively involved in competitive athletics
- Able to give informed consent
Key exclusion criteria (8 listed)
- Any known prior autonomic dysfunction
- History of seizures or taking anti-seizure medication
- Known learning disability or attention deficit disorder
- Chronic heart conditions such as arrhythmias or valvular disease
- History of diabetes mellitus
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 |
|---|---|---|
| PD2i AnalyzerAnalysis of heart rate variability from a standard digital ECG for 6-12 minutes | Device | Baseball players, Female basketball players, Female soccer players, Female vollyball players, Football players, Male basketball players, Male soccer players, Softball players |
Primary outcome
Change in PD2i following strenuous exercise bout of 45 minutes
Time frame: Baseline at zero minutes and within 60 minutes of completion of strenuous exercise bout.
PD2i analysis of HRV measured before and after strenuous exercise in each sport. The change from baseline will be correlated to return to resting heart rate.
1 secondary outcome
Change in PD2i following an injury during competitive sports.
Time frame: Baseline PD2i at zero and within 60 minutes of cessation of exercise bout.
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 12 Apr 2012.
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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.
Steve A Watts, MD principal investigator
University of Mississippi Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autonomic Dysfunction, run by University of Mississippi Medical Center at 1 site in United States.
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 8 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 12 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 PD2i following strenuous exercise bout of 45 minutes (time frame: Baseline at zero minutes and within 60 minutes of completion of strenuous exercise bout.). 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 12 Apr 2012.