Sexual Health on Antidepressants Through Physical Exercise (SHAPE)

The University of Texas System (UT)

Status: Completed

Conditions: Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological

Treatments: Behavioral: Physical activity

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01188720

F31MH085416 (U.S. NIH Grant/Contract)

2010-07-0043

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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52 participants in 3 patient groups

Baseline

No Intervention group

Description:

Assessment only baseline

Acute exercise

Experimental group

Description:

Exercise immediately before sexual activity, three times per week.

Treatment:

Behavioral: Physical activity

General exercise

Active Comparator group

Description:

Exercise not immediately before sexual activity, three times per week.

Treatment:

Behavioral: Physical activity