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Sexual Health on Antidepressants Through Physical Exercise (SHAPE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01188720
Recruitment Status : Completed
First Posted : August 25, 2010
Last Update Posted : May 27, 2015
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Tierney Kyle Ahrold Lorenz, University of Texas at Austin

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.

Condition or disease Intervention/treatment Phase
Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Behavioral: Physical activity Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Sexual Health on Antidepressants Through Physical Exercise
Study Start Date : November 2010
Actual Primary Completion Date : January 2012
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Baseline
Assessment only baseline
Experimental: Acute exercise
Exercise immediately before sexual activity, three times per week.
Behavioral: Physical activity
30 minutes of moderate to intense physical activity including strength training and cardiovascular activity.

Active Comparator: General exercise
Exercise not immediately before sexual activity, three times per week.
Behavioral: Physical activity
30 minutes of moderate to intense physical activity including strength training and cardiovascular activity.




Primary Outcome Measures :
  1. Sexual Functioning [ Time Frame: 10 weeks ]
    Sexual functioning as measured by the Female Sexual Functioning Index


Secondary Outcome Measures :
  1. Sexual satisfaction [ Time Frame: Baseline (0 weeks), 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks ]
    Sexual satisfaction as measured by self-report measure completed weekly throughout the trial

  2. Sexual Functioning [ Time Frame: 3 weeks, 6 weeks, 9 weeks ]
    Sexual functioning as measured by the Female Sexual Functioning Index will be measured in between each arm of the trial.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • female
  • age 18 or older
  • currently receiving a consistent dosage of escitalopram, citalopram, sertraline, desvenlafaxine, venlafaxine, or duloxetine
  • currently sexually active
  • willing and able to exercise
  • experiencing regular menstrual cycles
  • not currently pregnant and not intending to become pregnant during trial

Exclusion Criteria:

  • currently taking more than one psychoactive medication
  • factors indicating risk of cardiovascular activity, including acute or chronic cardiovascular illness, including clinically significant hypertension (defined as self-reported hypertension or "blood pressure greater than 140/90" or receiving medications designed to treat hypertension); recent chest pain; frequent or recurrent faint or dizzy spells; severe or untreated exercise-related asthma; or musculoskeletal illness or injury that would be expected to worsen with physical exercise. Additionally, women will be excluded if they are found to have any of the following as measured during the fitness assessment of the first session: a BMI over 40, waist circumference over 40 inches, waist-to-hip ratio of greater than 0.9, systolic blood pressure greater than 150 or diastolic pressure over 95, or resting heart rate over 90.
  • factors associated with significant genital nerve damage, including: previous major pelvic surgery that may have caused nerve damage, including hysterectomy, vulvectomy, circumcision, colostomy, cystostomy, or serious bladder, rectal, or abdominal surgery; or neurological impairment due to diabetes, stroke, pelvic nerve damage secondary to trauma, cancer treatments, myasthenia gravis, multiple sclerosis or spinal cord damage.
  • factors associated with non-normative endocrine function, including: perimenopausal or menopausal status, or >1 missed menstrual period in the previous 6 months; or currently pregnant, breastfeeding, or having breastfed within the past 3 months; or reporting clinically significant untreated renal or endocrine disease
  • untreated serious mental health conditions
  • sexual aversion or distress due to history of unwanted sexual contact

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01188720


Locations
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United States, Texas
University of Texas at Austin
Austin, Texas, United States, 78712
Sponsors and Collaborators
University of Texas at Austin
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Tierney K Lorenz, M.A. University of Texas at Austin

Additional Information:
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Responsible Party: Tierney Kyle Ahrold Lorenz, Researcher, University of Texas at Austin
ClinicalTrials.gov Identifier: NCT01188720    
Other Study ID Numbers: 2010-07-0043
F31MH085416 ( U.S. NIH Grant/Contract )
First Posted: August 25, 2010    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders
Genital Diseases, Male
Genital Diseases, Female
Antidepressive Agents
Psychotropic Drugs