Sexual Health on Antidepressants Through Physical Exercise (SHAPE)
This study is ongoing, but not recruiting participants.
Sponsor:
University of Texas at Austin
Collaborator:
Information provided by (Responsible Party):
Tierney Kyle Ahrold Lorenz, University of Texas at Austin
ClinicalTrials.gov Identifier:
NCT01188720
First received: August 20, 2010
Last updated: February 25, 2013
Last verified: February 2013
| Tracking Information | |||||
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| First Received Date ICMJE | August 20, 2010 | ||||
| Last Updated Date | February 25, 2013 | ||||
| Start Date ICMJE | November 2010 | ||||
| Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Sexual Functioning [ Time Frame: 10 weeks ] [ Designated as safety issue: No ] Sexual functioning as measured by the Female Sexual Functioning Index |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01188720 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Sexual Health on Antidepressants Through Physical Exercise | ||||
| Official Title ICMJE | Sexual Health on Antidepressants Through Physical Exercise | ||||
| Brief Summary | Preliminary findings from a trial in the investigators laboratory suggest that acute exercise may ameliorate deficits in sexual arousal associated with use of antidepressants. The goal of this project is to evaluate the real-world effectiveness of an exercise-based intervention for these side effects in a community-based sample. The investigators hypothesize that general exercise will help improve sexual functioning in women taking antidepressants, and that exercise immediately before sexual activity - that is, acute exercise - will have an additional beneficial effect above and beyond that of general exercise. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Supportive Care |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Physical activity
30 minutes of moderate to intense physical activity including strength training and cardiovascular activity. |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 75 | ||||
| Estimated Completion Date | August 2013 | ||||
| Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01188720 | ||||
| Other Study ID Numbers ICMJE | 2010-07-0043 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Tierney Kyle Ahrold Lorenz, University of Texas at Austin | ||||
| Study Sponsor ICMJE | University of Texas at Austin | ||||
| Collaborators ICMJE | National Institute of Mental Health (NIMH) | ||||
| Investigators ICMJE |
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| Information Provided By | University of Texas at Austin | ||||
| Verification Date | February 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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