NCT00143988

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2004

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

August 24, 2009

Status Verified

August 1, 2009

Enrollment Period

2.8 years

First QC Date

September 1, 2005

Last Update Submit

August 6, 2009

Conditions

Heart RateBlood Pressure

Keywords

Blood PressureHeart RateSexual Activity

Outcome Measures

Primary Outcomes (1)

  • physical stress during exercise

    during one measured encounter

Study Arms (4)

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

Interventions

Treadmill testingBEHAVIORAL

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

Also known as: Quinton treadmill will be used
Treadmill Test exertion femalesTreadmill test exertion males
Ambulatory Blood Pressure and Heart Rate MonitoringBEHAVIORAL

Patients will wear an ambulatory blood pressure monitor and an heart rate monitor during one sexual encounter.

Also known as: Space Labs ambulatory BP monitor, Polar heart rate monitor
Sexual activity exertion femalesSexual activity exertion males

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Men and women over the age of 40 who are sexually active

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08901, United States

Location

Related Publications (10)

  • 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.

    PMID: 8232456BACKGROUND

  • Tofler 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.

    PMID: 2193495BACKGROUND

  • Muller 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.

    PMID: 8618365BACKGROUND

  • Hellerstein HK, Friedman EH. Sexual activity and the postcoronary patient. Arch Intern Med. 1970 Jun;125(6):987-99. No abstract available.

    PMID: 4951941BACKGROUND

  • Bohlen 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.

    PMID: 6476990BACKGROUND

  • Green 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.

    PMID: 805515BACKGROUND

  • Nemec 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.

    PMID: 949020BACKGROUND

  • Mann 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.

    PMID: 6119996BACKGROUND

  • Drory 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.

    PMID: 7717293BACKGROUND

  • Standards 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.

    PMID: 759014BACKGROUND

MeSH Terms

Conditions

Sexual Behavior

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Officials

  • Sebastian Palmeri, MD

    Rutgers, The State University of New Jersey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 1, 2005

First Posted

September 2, 2005

Study Start

May 1, 2004

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

August 24, 2009

Record last verified: 2009-08

Locations

US(1)