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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00143988
First received: September 1, 2005
Last updated: August 6, 2009
Last verified: August 2009
  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:


Further study details as provided by Rutgers, The State University of 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

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 of New Jersey
Pfizer
Investigators
Principal Investigator: Sebastian Palmeri, MD Rutgers, The State University of New Jersey
  More Information

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

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 Rutgers, The State University of New Jersey:
Blood Pressure
Heart Rate
Sexual Activity

ClinicalTrials.gov processed this record on August 28, 2014