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

NCT00143988

Last updated date
Study Location
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Heart Rate, Blood Pressure
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40-80 years
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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

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Heart Rate, Blood PressureHeart Rate and Blood Pressure Response During Exercise and Sexual Activity in Normotensive and Hypertensive Volunteers
NCT00143988
  1. New Brunswick, New Jersey
ALL GENDERS
40 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Heart Rate and Blood Pressure Response During Exercise and Sexual Activity in Normotensive and Hypertensive Volunteers
Official Title Heart Rate and Blood Pressure Response During Exercise and Sexual Activity in Normotensive and Hypertensive Volunteers
Brief Summary 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 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
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Men and women over the age of 40 who are sexually active
Condition
  • Heart Rate
  • Blood Pressure
Intervention
  • 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
Study Groups/Cohorts
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 6, 2009)
36
Original Enrollment
 (submitted: September 1, 2005)
80
Actual Study Completion Date March 2007
Actual Primary Completion Date March 2007   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study:All
Ages 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00143988
Other Study ID Numbers 3255
investigator initiated trial
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Sebastian T. Palmeri, MD - Principal Investigator, UMDNJ-Robert Wood Johnson Medical School
Study Sponsor University of Medicine and Dentistry of New Jersey
Collaborators Pfizer
Investigators
Principal Investigator:Sebastian Palmeri, MDRutgers, The State University of New Jersey
PRS Account Rutgers, The State University of New Jersey
Verification Date August 2009