Heart RateSEXERRCISENCT00143988
Heart Rate and Blood Pressure Response During Exercise and Sexual Activity in Normotensive and Hypertensive Volunteers
An observational study of Heart Rate and Blood Pressure, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.
Trial summary
The purpose of this study is to determine the amount of cardiac work as measured by heart rate and blood pressure during physical exertion compared to sexual activity. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Rate, Blood Pressure
- What is being tested?
- Treadmill testing and Ambulatory Blood Pressure and Heart Rate Monitoring
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to Mar 2007
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Men and women over the age of 40 who are sexually active
Who may be able to join
- 1) Male or female age 40-80
Who cannot join
- Current sexual partner less than six months duration or sexually inactive patients defined as engaging in sexual intercourse less than one time monthly
- Uncontrolled hypertension (resting blood pressure >160/100); secondary hypertension; renal failure (serum creatinine >3.0); congestive heart failure (NYHA functional Class III-IV); acute coronary syndrome; PCI or open heart surgery within past 3 months; cerebrovascular disease within the past 6 months and any other major medical or psychiatric disorder.
- Individuals who regularly (more than 3 times weekly) perform rigorous physical exercise.
- Individuals unable to perform an exercise treadmill stress test.
- Lack of informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901
About this study
The purpose of this study is to determine the amount of cardiac work as measured by heart rate and blood pressure during physical exertion compared to sexual activity.
Read the detailed description
Physical exertion will be measured by a standardized treadmill test. Sexual activity will be performed in the study subject's home with his/her spouse or regular partner. Each study subject will wear a blood pressure and heart rate monitor at home during their sexual activity and will be asked to complete a one page diary upon completion of the activity. Normotensive and subject with mild hypertension will be studied to determine if hypertensive subjects have a relatively greater increase in their blood pressure during either physical exercise or sexual activity.
- Conditions
- Heart Rate, Blood Pressure
- Being tested
- Treadmill testing, Ambulatory Blood Pressure and Heart Rate Monitoring
- Keywords
- Blood Pressure, Heart Rate, Sexual Activity
- Medical subject headings
- Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treadmill testingBehavioural
Also called Quinton treadmill will be used
Patients will have a exercise stress test using a Bruce protocol during which time heart rates and blood pressures will be monitored and the patient's percieved exertion level monitored and recorded
Ambulatory Blood Pressure and Heart Rate MonitoringBehavioural
Also called Space Labs ambulatory BP monitor, Polar heart rate monitor
Patients will wear an ambulatory blood pressure monitor and an heart rate monitor during one sexual encounter.
| Study group | Role | What they receive |
|---|---|---|
| Treadmill Test exertion females | Not described Receives: Behavioral: Treadmill testing | |
| Treadmill test exertion males | Not described Receives: Behavioral: Treadmill testing | |
| Sexual activity exertion females | Not described Receives: Behavioral: Ambulatory Blood Pressure and Heart Rate Monitoring | |
| Sexual activity exertion males | Not described Receives: Behavioral: Ambulatory Blood Pressure and Heart Rate Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
physical stress during exercise
Measured: during one measured encounter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startMay 2004
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Heart RateStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Dentistry of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- Sebastian Palmeri, MD, Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00143988
- Sponsor's protocol ID
- 3255
- Other IDs
- investigator initiated trial
- Acronym
- SEXERRCISE
- Status last verified
- Aug 2009
- First submitted
- 1 Sep 2005
- Last updated
- 24 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Mittleman MA, Maclure M, Tofler GH, Sherwood JB, Goldberg RJ, Muller JE. Triggering of acute myocardial infarction by heavy physical exertion. Protection against triggering by regular exertion. Determinants of Myocardial Infarction Onset Study Investigators. N Engl J Med. 1993 Dec 2;329(23):1677-83. doi: 10.1056/NEJM199312023292301.
PubMed 8232456Tofler GH, Stone PH, Maclure M, Edelman E, Davis VG, Robertson T, Antman EM, Muller JE. Analysis of possible triggers of acute myocardial infarction (the MILIS study). Am J Cardiol. 1990 Jul 1;66(1):22-7. doi: 10.1016/0002-9149(90)90729-k.
PubMed 2193495Muller JE, Mittleman MA, Maclure M, Sherwood JB, Tofler GH. Triggering myocardial infarction by sexual activity. Low absolute risk and prevention by regular physical exertion. Determinants of Myocardial Infarction Onset Study Investigators. JAMA. 1996 May 8;275(18):1405-9. doi: 10.1001/jama.275.18.1405.
PubMed 8618365Hellerstein HK, Friedman EH. Sexual activity and the postcoronary patient. Arch Intern Med. 1970 Jun;125(6):987-99. No abstract available.
PubMed 4951941Bohlen JG, Held JP, Sanderson MO, Patterson RP. Heart rate, rate-pressure product, and oxygen uptake during four sexual activities. Arch Intern Med. 1984 Sep;144(9):1745-8.
PubMed 6476990Green AW. Sexual activity and the postmyocardial infarction patient. Am Heart J. 1975 Feb;89(2):246-52. doi: 10.1016/0002-8703(75)90055-1. No abstract available.
PubMed 805515Nemec ED, Mansfield L, Kennedy JW. Heart rate and blood pressure responses during sexual activity in normal males. Am Heart J. 1976 Sep;92(3):274-7. doi: 10.1016/s0002-8703(76)80106-8.
PubMed 949020Mann S, Craig MW, Gould BA, Melville DI, Raftery EB. Coital blood pressure in hypertensives. Cephalgia, syncope, and the effects of beta-blockade. Br Heart J. 1982 Jan;47(1):84-9. doi: 10.1136/hrt.47.1.84.
PubMed 6119996Drory Y, Shapira I, Fisman EZ, Pines A. Myocardial ischemia during sexual activity in patients with coronary artery disease. Am J Cardiol. 1995 Apr 15;75(12):835-7. doi: 10.1016/s0002-9149(99)80425-1. No abstract available.
PubMed 7717293Standards for adult exercise testing laboratories. American Heart Association Subcommittee on Rehabilitation, Target Activity Group. Circulation. 1979 Feb;59(2):421A-430A passim. No abstract available.
PubMed 759014
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Rate and Blood Pressure Response During Exercise and Sexual Activity in Normotensive and Hypertensive Volunteers
- ClinicalTrials.gov ID
- NCT00143988
- Acronym / sponsor ID
- SEXERRCISE / 3255
- Conditions
- Heart Rate, Blood Pressure
- Keywords
- Blood Pressure, Heart Rate, Sexual Activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of Medicine and Dentistry of New JerseyUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- May 2004
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 2 Sep 2005 (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.
The purpose of this study is to determine the amount of cardiac work as measured by heart rate and blood pressure during physical exertion compared to sexual activity.
Detailed description
Physical exertion will be measured by a standardized treadmill test. Sexual activity will be performed in the study subject's home with his/her spouse or regular partner. Each study subject will wear a blood pressure and heart rate monitor at home during their sexual activity and will be asked to complete a one page diary upon completion of the activity. Normotensive and subject with mild hypertension will be studied to determine if hypertensive subjects have a relatively greater increase in their blood pressure during either physical exercise or sexual activity.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treadmill Test exertion females | – | Behavioral: Treadmill testing |
| Treadmill test exertion males | – | Behavioral: Treadmill testing |
| Sexual activity exertion females | – | Behavioral: Ambulatory Blood Pressure and Heart Rate Monitoring |
| Sexual activity exertion males | – | Behavioral: Ambulatory Blood Pressure and Heart Rate Monitoring |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women over the age of 40 who are sexually active
Key inclusion criteria (1 listed)
- 1) Male or female age 40-80
Key exclusion criteria (5 listed)
- Current sexual partner less than six months duration or sexually inactive patients defined as engaging in sexual intercourse less than one time monthly
- Uncontrolled hypertension (resting blood pressure >160/100); secondary hypertension; renal failure (serum creatinine >3.0); congestive heart failure (NYHA functional Class III-IV); acute coronary syndrome; PCI or open heart surgery within past 3 months; cerebrovascular disease within the past 6 months and any other major medical or psychiatric disorder.
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 |
|---|---|---|
| Treadmill testingAlso: Quinton treadmill will be usedPatients will have a exercise stress test using a Bruce protocol during which time heart rates and blood pressures will be monitored and the patient's percieved exertion level monitored and recorded | Behavioural | Treadmill Test exertion females, Treadmill test exertion males |
| Ambulatory Blood Pressure and Heart Rate MonitoringAlso: Space Labs ambulatory BP monitor, Polar heart rate monitorPatients will wear an ambulatory blood pressure monitor and an heart rate monitor during one sexual encounter. | Behavioural | Sexual activity exertion females, Sexual activity exertion males |
Primary outcome
physical stress during exercise
Time frame: during one measured encounter
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 24 Aug 2009.
- Background: PubMed 8232456Mittleman MA, Maclure M, Tofler GH, Sherwood JB, Goldberg RJ, Muller JE. Triggering of acute myocardial infarction by heavy physical exertion. Protection against triggering by regular exertion. Determinants of Myocardial Infarction Onset Study Investigators. N Engl J Med. 1993 Dec 2;329(23):1677-83. doi: 10.1056/NEJM199312023292301.
- Background: PubMed 2193495Tofler GH, Stone PH, Maclure M, Edelman E, Davis VG, Robertson T, Antman EM, Muller JE. Analysis of possible triggers of acute myocardial infarction (the MILIS study). Am J Cardiol. 1990 Jul 1;66(1):22-7. doi: 10.1016/0002-9149(90)90729-k.
- Background: PubMed 8618365Muller JE, Mittleman MA, Maclure M, Sherwood JB, Tofler GH. Triggering myocardial infarction by sexual activity. Low absolute risk and prevention by regular physical exertion. Determinants of Myocardial Infarction Onset Study Investigators. JAMA. 1996 May 8;275(18):1405-9. doi: 10.1001/jama.275.18.1405.
- Background: PubMed 4951941Hellerstein HK, Friedman EH. Sexual activity and the postcoronary patient. Arch Intern Med. 1970 Jun;125(6):987-99. No abstract available.
- Background: PubMed 6476990Bohlen JG, Held JP, Sanderson MO, Patterson RP. Heart rate, rate-pressure product, and oxygen uptake during four sexual activities. Arch Intern Med. 1984 Sep;144(9):1745-8.
- Background: PubMed 805515Green AW. Sexual activity and the postmyocardial infarction patient. Am Heart J. 1975 Feb;89(2):246-52. doi: 10.1016/0002-8703(75)90055-1. No abstract available.
- Background: PubMed 949020Nemec ED, Mansfield L, Kennedy JW. Heart rate and blood pressure responses during sexual activity in normal males. Am Heart J. 1976 Sep;92(3):274-7. doi: 10.1016/s0002-8703(76)80106-8.
- Background: PubMed 6119996Mann S, Craig MW, Gould BA, Melville DI, Raftery EB. Coital blood pressure in hypertensives. Cephalgia, syncope, and the effects of beta-blockade. Br Heart J. 1982 Jan;47(1):84-9. doi: 10.1136/hrt.47.1.84.
- Background: PubMed 7717293Drory Y, Shapira I, Fisman EZ, Pines A. Myocardial ischemia during sexual activity in patients with coronary artery disease. Am J Cardiol. 1995 Apr 15;75(12):835-7. doi: 10.1016/s0002-9149(99)80425-1. No abstract available.
- Background: PubMed 759014Standards for adult exercise testing laboratories. American Heart Association Subcommittee on Rehabilitation, Target Activity Group. Circulation. 1979 Feb;59(2):421A-430A passim. No abstract available.
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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.
Sebastian Palmeri, MD principal investigator
Rutgers, The State University of New Jersey
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 Heart Rate and Blood Pressure, run by University of Medicine and Dentistry of New Jersey 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 1 inclusion and 5 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 24 Aug 2009. 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?
physical stress during exercise (time frame: during one measured encounter). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00143988, which also lists 10 linked publications.
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 24 Aug 2009.