Heart Rate and Blood Pressure Response During Exercise and Sexual Activity in Normotensive and Hypertensive Volunteers
NCT00143988
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Adult Trials: 18+ Years
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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| 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 |
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| Intervention |
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| Study Groups/Cohorts |
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| Publications * |
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* 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 | 36 | |||
| Original Enrollment | 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
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| Sex/Gender |
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| 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 |
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| PRS Account | Rutgers, The State University of New Jersey | |||
| Verification Date | August 2009 | |||