Sexual Health on Antidepressants Through Physical Exercise (SHAPE)
Primary Purpose
Sexual Dysfunction, Physiological, Sexual Dysfunctions, Psychological
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical activity
Sponsored by
About this trial
This is an interventional supportive care trial for Sexual Dysfunction, Physiological
Eligibility Criteria
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
Sites / Locations
- University of Texas at Austin
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Active Comparator
Arm Label
Baseline
Acute exercise
General exercise
Arm Description
Assessment only baseline
Exercise immediately before sexual activity, three times per week.
Exercise not immediately before sexual activity, three times per week.
Outcomes
Primary Outcome Measures
Sexual Functioning
Sexual functioning as measured by the Female Sexual Functioning Index
Secondary Outcome Measures
Sexual satisfaction
Sexual satisfaction as measured by self-report measure completed weekly throughout the trial
Sexual Functioning
Sexual functioning as measured by the Female Sexual Functioning Index will be measured in between each arm of the trial.
Full Information
NCT ID
NCT01188720
First Posted
August 20, 2010
Last Updated
May 26, 2015
Sponsor
University of Texas at Austin
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT01188720
Brief Title
Sexual Health on Antidepressants Through Physical Exercise
Acronym
SHAPE
Official Title
Sexual Health on Antidepressants Through Physical Exercise
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Dysfunction, Physiological, Sexual Dysfunctions, Psychological
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Baseline
Arm Type
No Intervention
Arm Description
Assessment only baseline
Arm Title
Acute exercise
Arm Type
Experimental
Arm Description
Exercise immediately before sexual activity, three times per week.
Arm Title
General exercise
Arm Type
Active Comparator
Arm Description
Exercise not immediately before sexual activity, three times per week.
Intervention Type
Behavioral
Intervention Name(s)
Physical activity
Intervention Description
30 minutes of moderate to intense physical activity including strength training and cardiovascular activity.
Primary Outcome Measure Information:
Title
Sexual Functioning
Description
Sexual functioning as measured by the Female Sexual Functioning Index
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Sexual satisfaction
Description
Sexual satisfaction as measured by self-report measure completed weekly throughout the trial
Time Frame
Baseline (0 weeks), 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks
Title
Sexual Functioning
Description
Sexual functioning as measured by the Female Sexual Functioning Index will be measured in between each arm of the trial.
Time Frame
3 weeks, 6 weeks, 9 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tierney K Lorenz, M.A.
Organizational Affiliation
University of Texas at Austin
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas at Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mestonlab.com
Description
Laboratory webpage
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Sexual Health on Antidepressants Through Physical Exercise
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