Heart Rate and Blood Pressure Response During Exercise and Sexual Activity in Normotensive and Hypertensive Volunteers

Blood Pressure Clinical Trial

— SEXERRCISE  

Official title:

Heart Rate and Blood Pressure Response During Exercise and Sexual Activity in Normotensive and Hypertensive Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00143988
• Other study ID #: 3255
• Secondary ID: investigator ini
• Status: Completed
• Phase: N/A
• First received: September 1, 2005
• Last updated: August 6, 2009
• Start date: May 2004
• Est. completion date: March 2007

Study information

• Verified date: August 2009
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteri

1) Male or female age 40-80

Exclusion Criteria

1. Current sexual partner less than six months duration or sexually inactive patients defined as engaging in sexual intercourse less than one time monthly

2. 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Blood Pressure
• Heart Rate

Intervention

Behavioral:
• Treadmill testing
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 Monitoring
Patients will wear an ambulatory blood pressure monitor and an heart rate monitor during one sexual encounter.

Locations

Country	Name	City	State
United States	Robert Wood Johnson University Hospital	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
University of Medicine and Dentistry of New Jersey	Pfizer

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

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. — View Citation

Green AW. Sexual activity and the postmyocardial infarction patient. Am Heart J. 1975 Feb;89(2):246-52. Review. — View Citation

Hellerstein HK, Friedman EH. Sexual activity and the postcoronary patient. Arch Intern Med. 1970 Jun;125(6):987-99. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Standards for adult exercise testing laboratories. American Heart Association Subcommittee on Rehabilitation, Target Activity Group. Circulation. 1979 Feb;59(2):421A-430A passim. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	physical stress during exercise		during one measured encounter	No