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Completed

NCT Number: NCT01188720

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.

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Key information

Conditions

Sexual Dysfunction, Physiological Genital Diseases Mental Disorders Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas at Austin

Austin, Texas, 78712, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical activity

Behavioral

30 minutes of moderate to intense physical activity including strength training and cardiovascular activity.

Primary outcomes

  1. Sexual Functioning

    Time frame: 10 weeks

    Sexual functioning as measured by the Female Sexual Functioning Index

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Acronym: SHAPE

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Aug 25, 2010
Registry last updated
May 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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