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

This study is currently recruiting patients.
Verified by University of Medicine and Dentistry New Jersey September 2005

Sponsors and Collaborators: University of Medicine and Dentistry New Jersey
Pfizer
Information provided by: University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier: NCT00143988

Purpose

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.
Intervention
 Behavior: Treadmill Test of Exertion

MedlinePlus consumer health information 

Study Type: Observational
Study Design: Screening, Cross-Sectional, Defined Population, Prospective Study

Official Title: Heart Rate and Blood Pressure Response During Exercise and Sexual Activity in Normotensive and Hypertensive Volunteers.

Further Study Details: 

Expected Total Enrollment:  80

Study start: May 2004;  Expected completion: December 2006
Last follow-up: December 2006;  Data entry closure: December 2006

Physicial 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.

Eligibility

Ages Eligible for Study:  40 Years   -   80 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria

  • Male or female age 40-80

Exclusion Criteria

  • 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.
  • Indiviuals who regularly (more than 3 times weekly) perform rigorous physical exercise.
  • Individuals unable to perform an exercise treadmill stress test.
  • Lack of informed consent

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00143988

Sebastian Palmeri, MD      732-235-7855    palmerse@umdnj.edu

New Jersey
      Robert Wood Johnson University Hospital, New Brunswick,  New Jersey,  08901,  United States; Recruiting
Laurie Casazza, RN  732-235-8694    casazzla@umdnj.edu 
Sebastian Palmeri, MD,  Principal Investigator

Study chairs or principal investigators

Sebastian Palmeri, MD,  Principal Investigator,  University of Medicine and Dentistry New Jersey   

More Information

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.

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.

Muller JE, Mittleman A, 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.

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

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.

Green AW. Sexual activity and the postmyocardial infarction patient. Am Heart J. 1975 Feb;89(2):246-52. Review. No abstract available.

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.

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.

[No authors listed] 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.

Study ID Numbers:  3255
Last Updated:  September 1, 2005
Record first received:  September 1, 2005
ClinicalTrials.gov Identifier:  NCT00143988
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-06



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