Sexual Health on Antidepressants Through Physical Exercise (SHAPE)

This study is ongoing, but not recruiting participants.
Sponsor:
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

August 20, 2010
February 25, 2013
November 2010
January 2012   (final data collection date for primary outcome measure)
Sexual Functioning [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Sexual functioning as measured by the Female Sexual Functioning Index
Same as current
Complete list of historical versions of study NCT01188720 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
    Sexual satisfaction as measured by self-report measure completed weekly throughout the trial
  • Sexual Functioning [ Time Frame: 3 weeks, 6 weeks, 9 weeks ] [ Designated as safety issue: No ]
    Sexual functioning as measured by the Female Sexual Functioning Index will be measured in between each arm of the trial.
Same as current
Not Provided
Not Provided
 
Sexual Health on Antidepressants Through Physical Exercise
Sexual Health on Antidepressants Through Physical Exercise

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Sexual Dysfunction, Physiological
  • Sexual Dysfunctions, Psychological
Behavioral: Physical activity
30 minutes of moderate to intense physical activity including strength training and cardiovascular activity.
  • No Intervention: Baseline
    Assessment only baseline
  • Experimental: Acute exercise
    Exercise immediately before sexual activity, three times per week.
    Intervention: Behavioral: Physical activity
  • Active Comparator: General exercise
    Exercise not immediately before sexual activity, three times per week.
    Intervention: Behavioral: Physical activity
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
75
August 2013
January 2012   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01188720
2010-07-0043
No
Tierney Kyle Ahrold Lorenz, University of Texas at Austin
University of Texas at Austin
National Institute of Mental Health (NIMH)
Principal Investigator: Tierney K Lorenz, M.A. University of Texas at Austin
University of Texas at Austin
February 2013

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