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

September 1, 2005
August 6, 2009
May 2004
March 2007   (final data collection date for primary outcome measure)
physical stress during exercise [ Time Frame: during one measured encounter ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00143988 on ClinicalTrials.gov Archive Site
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Heart Rate and Blood Pressure Response During Exercise and Sexual Activity in Normotensive and Hypertensive Volunteers
Heart Rate and Blood Pressure Response During Exercise and Sexual Activity in Normotensive and Hypertensive Volunteers

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

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

  • Heart Rate
  • Blood Pressure
  • 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
  • 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
  • Treadmill Test exertion females
    Intervention: Behavioral: Treadmill testing
  • Treadmill test exertion males
    Intervention: Behavioral: Treadmill testing
  • Sexual activity exertion females
    Intervention: Behavioral: Ambulatory Blood Pressure and Heart Rate Monitoring
  • Sexual activity exertion males
    Intervention: Behavioral: Ambulatory Blood Pressure and Heart Rate Monitoring

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
March 2007
March 2007   (final data collection date for primary outcome measure)

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
Both
40 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00143988
3255, investigator initiated trial
No
Sebastian T. Palmeri, MD - Principal Investigator, UMDNJ-Robert Wood Johnson Medical School
University of Medicine and Dentistry of New Jersey
Pfizer
Principal Investigator: Sebastian Palmeri, MD Rutgers, The State University of New Jersey
Rutgers, The State University of New Jersey
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP