Heart Rate and Blood Pressure Response During Exercise and Sexual Activity in Normotensive and Hypertensive Volunteers - Full Text View

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.

Condition	Intervention
Heart Rate Blood Pressure	Behavioral: Treadmill testing Behavioral: Ambulatory Blood Pressure and Heart Rate Monitoring

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Heart Rate and Blood Pressure Response During Exercise and Sexual Activity in Normotensive and Hypertensive Volunteers

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness

U.S. FDA Resources

Further study details as provided by University of Medicine and Dentistry New Jersey:

Primary Outcome Measures:

physical stress during exercise [ Time Frame: during one measured encounter ] [ Designated as safety issue: No ]

Enrollment:	36
Study Start Date:	May 2004
Study Completion Date:	March 2007
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Treadmill Test exertion females	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 Other Name: Quinton treadmill will be used
Treadmill test exertion males	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 Other Name: Quinton treadmill will be used
Sexual activity exertion females	Behavioral: Ambulatory Blood Pressure and Heart Rate Monitoring Patients will wear an ambulatory blood pressure monitor and an heart rate monitor during one sexual encounter. Other Names: Space Labs ambulatory BP monitor Polar heart rate monitor
Sexual activity exertion males	Behavioral: Ambulatory Blood Pressure and Heart Rate Monitoring Patients will wear an ambulatory blood pressure monitor and an heart rate monitor during one sexual encounter. Other Names: Space Labs ambulatory BP monitor Polar heart rate monitor

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.

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

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

Criteria

Inclusion Criteri

1) 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.
- 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00143988

Locations

United States, New Jersey
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08901

Sponsors and Collaborators

University of Medicine and Dentistry New Jersey

Pfizer

Investigators

Principal Investigator:

Sebastian Palmeri, MD

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.

Drory Y, Shapira I, Fisman EZ, Pines A. Patients with coronary artery disease. Brief Reports The American Journal of Cardiology. 1995;75:835-837.

[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.

Responsible Party:	Sebastian T. Palmeri, MD - Principal Investigator, UMDNJ-Robert Wood Johnson Medical School
ClinicalTrials.gov Identifier:	NCT00143988 History of Changes
Other Study ID Numbers:	3255, investigator initiated trial
Study First Received:	September 1, 2005
Last Updated:	August 6, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Medicine and Dentistry New Jersey:

Blood Pressure
Heart Rate
Sexual Activity

ClinicalTrials.gov processed this record on May 19, 2013

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