Sexual Health on Antidepressants Through Physical Exercise

Sexual Dysfunctions, Psychological Clinical Trial

— SHAPE  

Official title:

Sexual Health on Antidepressants Through Physical Exercise

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01188720
• Other study ID #: 2010-07-0043
• Secondary ID: F31MH085416
• Status: Completed
• Phase: N/A
• First received: August 20, 2010
• Last updated: May 26, 2015
• Start date: November 2010
• Est. completion date: August 2013

Study information

• Verified date: May 2015
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: August 2013
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Sexual Dysfunction, Physiological
• Sexual Dysfunctions, Psychological

Intervention

Behavioral:
• Physical activity
30 minutes of moderate to intense physical activity including strength training and cardiovascular activity.

Locations

Country	Name	City	State
United States	University of Texas at Austin	Austin	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas at Austin	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sexual Functioning	Sexual functioning as measured by the Female Sexual Functioning Index	10 weeks	No
Secondary	Sexual satisfaction	Sexual satisfaction as measured by self-report measure completed weekly throughout the trial	Baseline (0 weeks), 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks	No
Secondary	Sexual Functioning	Sexual functioning as measured by the Female Sexual Functioning Index will be measured in between each arm of the trial.	3 weeks, 6 weeks, 9 weeks	No

External Links

•   Laboratory webpage