Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT01188720
Status:
COMPLETED
Last Update Posted:
2015-05-27
First Post:
2010-08-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sexual Health on Antidepressants Through Physical Exercise
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-26', 'studyFirstSubmitDate': '2010-08-20', 'studyFirstSubmitQcDate': '2010-08-24', 'lastUpdatePostDateStruct': {'date': '2015-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sexual Functioning', 'timeFrame': '10 weeks', 'description': 'Sexual functioning as measured by the Female Sexual Functioning Index'}], 'secondaryOutcomes': [{'measure': 'Sexual satisfaction', 'timeFrame': 'Baseline (0 weeks), 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks', 'description': 'Sexual satisfaction as measured by self-report measure completed weekly throughout the trial'}, {'measure': 'Sexual Functioning', 'timeFrame': '3 weeks, 6 weeks, 9 weeks', 'description': 'Sexual functioning as measured by the Female Sexual Functioning Index will be measured in between each arm of the trial.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sexual Dysfunction, Physiological', 'Sexual Dysfunctions, Psychological']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mestonlab.com', 'label': 'Laboratory webpage'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female\n* age 18 or older\n* currently receiving a consistent dosage of escitalopram, citalopram, sertraline, desvenlafaxine, venlafaxine, or duloxetine\n* currently sexually active\n* willing and able to exercise\n* experiencing regular menstrual cycles\n* not currently pregnant and not intending to become pregnant during trial\n\nExclusion Criteria:\n\n* currently taking more than one psychoactive medication\n* 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.\n* 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.\n* 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\n* untreated serious mental health conditions\n* sexual aversion or distress due to history of unwanted sexual contact'}, 'identificationModule': {'nctId': 'NCT01188720', 'acronym': 'SHAPE', 'briefTitle': 'Sexual Health on Antidepressants Through Physical Exercise', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas at Austin'}, 'officialTitle': 'Sexual Health on Antidepressants Through Physical Exercise', 'orgStudyIdInfo': {'id': '2010-07-0043'}, 'secondaryIdInfos': [{'id': 'F31MH085416', 'link': 'https://reporter.nih.gov/quickSearch/F31MH085416', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Baseline', 'description': 'Assessment only baseline'}, {'type': 'EXPERIMENTAL', 'label': 'Acute exercise', 'description': 'Exercise immediately before sexual activity, three times per week.', 'interventionNames': ['Behavioral: Physical activity']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'General exercise', 'description': 'Exercise not immediately before sexual activity, three times per week.', 'interventionNames': ['Behavioral: Physical activity']}], 'interventions': [{'name': 'Physical activity', 'type': 'BEHAVIORAL', 'description': '30 minutes of moderate to intense physical activity including strength training and cardiovascular activity.', 'armGroupLabels': ['Acute exercise', 'General exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78712', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas at Austin', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Tierney K Lorenz, M.A.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas at Austin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas at Austin', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Researcher', 'investigatorFullName': 'Tierney Kyle Ahrold Lorenz', 'investigatorAffiliation': 'University of Texas at Austin'}}}}