Sexual Health on Antidepressants Through Physical Exercise

NCT01188720 | Completed

• 2 other identifiers: 2010-07-0043F31MH085416
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological

Outcome Measures

Primary Outcomes (1)

• Sexual Functioning

  Sexual functioning as measured by the Female Sexual Functioning Index

  10 weeks

Secondary Outcomes (2)

• Sexual satisfaction

  Baseline (0 weeks), 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks

• Sexual Functioning

  3 weeks, 6 weeks, 9 weeks

Study Arms (3)

Baseline

NO INTERVENTION

Assessment only baseline

Acute exercise

EXPERIMENTAL

Exercise immediately before sexual activity, three times per week.

Behavioral: Physical activity

General exercise

ACTIVE COMPARATOR

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

Behavioral: Physical activity

Interventions

Physical activity BEHAVIORAL

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

Acute exercise; General exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas at Austin: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712, United States

Location

Related Links

• Laboratory webpage

MeSH Terms

Conditions

Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological

Interventions

Exercise

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Tierney K Lorenz, M.A.

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: August 20, 2010
• First Posted: August 25, 2010
• Study Start: November 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: August 1, 2013
• Last Updated: May 27, 2015

Record last verified: 2015-05

Locations

US (1)