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

NCT ID: NCT00143988

Last Updated: 2009-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-05-31

Study Completion Date

2007-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Rate Blood Pressure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treadmill Test exertion females

Treadmill testing

Intervention Type BEHAVIORAL

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

Treadmill test exertion males

Treadmill testing

Intervention Type BEHAVIORAL

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

Sexual activity exertion females

Ambulatory Blood Pressure and Heart Rate Monitoring

Intervention Type BEHAVIORAL

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

Sexual activity exertion males

Ambulatory Blood Pressure and Heart Rate Monitoring

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Quinton treadmill will be used Space Labs ambulatory BP monitor Polar heart rate monitor

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role collaborator

University of Medicine and Dentistry of New Jersey

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

UMDNJ-Robert Wood Johnson Medical School

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sebastian Palmeri, MD

Role: PRINCIPAL_INVESTIGATOR

Rutgers, The State University of New Jersey

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 8232456 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2193495 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8618365 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 4951941 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6476990 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 805515 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 949020 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6119996 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7717293 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 759014 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

investigator initiated trial

Identifier Type: -

Identifier Source: secondary_id

3255

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

AM vs PM Exercise Training
NCT06042439 RECRUITING NA
Cardiovascular Effects of Sporting Events
NCT00795405 COMPLETED EARLY_PHASE1