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

August 6, 2009 updated by: University of Medicine and Dentistry of New Jersey
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 Names:
  • 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
physical stress during exercise
Time Frame: during one measured encounter
during one measured encounter

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Medicine and Dentistry of New Jersey

Collaborators

Pfizer

Investigators

  • Principal Investigator: Sebastian Palmeri, MD, Rutgers, the State University of New Jersey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

September 1, 2005

First Submitted That Met QC Criteria

September 1, 2005

First Posted (Estimate)

September 2, 2005

Study Record Updates

Last Update Posted (Estimate)

August 24, 2009

Last Update Submitted That Met QC Criteria

August 6, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 3255
  • investigator initiated trial

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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