Sexual Health on Antidepressants Through Physical Exercise (SHAPE)
2015年5月26日 更新者：Tierney Kyle Ahrold Lorenz、University of Texas at Austin
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.
研究概览
研究类型
介入性
注册 (实际的)
52
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Texas
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Austin、Texas、美国、78712
- University of Texas at Austin
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：Baseline
Assessment only baseline
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|
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实验性的：Acute exercise
Exercise immediately before sexual activity, three times per week.
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30 minutes of moderate to intense physical activity including strength training and cardiovascular activity.
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有源比较器：General exercise
Exercise not immediately before sexual activity, three times per week.
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30 minutes of moderate to intense physical activity including strength training and cardiovascular activity.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Sexual Functioning
大体时间：10 weeks
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Sexual functioning as measured by the Female Sexual Functioning Index
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10 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Sexual satisfaction
大体时间：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
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Baseline (0 weeks), 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks
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Sexual Functioning
大体时间：3 weeks, 6 weeks, 9 weeks
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Sexual functioning as measured by the Female Sexual Functioning Index will be measured in between each arm of the trial.
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3 weeks, 6 weeks, 9 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Tierney K Lorenz, M.A.、University of Texas at Austin
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
有用的网址
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2010年11月1日
初级完成 (实际的)
2012年1月1日
研究完成 (实际的)
2013年8月1日
研究注册日期
首次提交
2010年8月20日
首先提交符合 QC 标准的
2010年8月24日
首次发布 (估计)
2010年8月25日
研究记录更新
最后更新发布 (估计)
2015年5月27日
上次提交的符合 QC 标准的更新
2015年5月26日
最后验证
2015年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Physical activity的临床试验
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