Effects of Zero-Time Exercise (ZTEx) on Inactive Adults With Insomnia
Effects of Zero-Time Exercise (ZTEx) on Inactive Adults With Insomnia: A Pilot Randomized Controlled Trial
Objectives: To evaluate the clinical effects of Zero-Time Exercise (ZTEx) for treating insomnia disorder delivered by a training course.
Hypothesis: Subjects in the ZTEx training group will have greater improvement in insomnia symptoms and daytime impairment than those in the sleep hygiene education (SHE) group at week 8.
Design and subjects: A randomized controlled trial. 32 inactive subjects with insomnia disorder recruited from the community will be randomized to ZTEx training or SHE groups in a 1: 1 ratio.
Study instrument: Insomnia Severity Index (ISI) will be used to assess insomnia symptoms and daytime impairment.
Interventions: Subjects in the ZTEx training group will attend two training lessons (2-hour each) to learn ZTEx and practice it every night for 8 weeks; subjects in the SHE group will receive sleep hygiene education with the schedule and duration that are same to the ZTEx training group.
Main outcome measures: The primary outcome measure is the ISI score. Other measures include sleep parameters by subjective sleep diary and objective actigraphy, Hospital Anxiety and Depression Scale, Multidimensional Fatigue Inventory-20 and Short Form-6 Dimension. Acceptability and compliance of ZTEx will be evaluated.
Data Analysis: Differences in the questionnaire scores, subjective and objective sleep parameters will be examined using a mixed-effects model.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Hong Kong、香港
- School of Nursing, The Hong Kong Polytechnic University
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Adults age 18-65 years old;
- Chinese Hong Kong residents who are able to communicate in Cantonese or Mandarin;
- A current clinical Diagnostic and Statistical Manual of Mental Disorders-fifth edition (DSM-5) diagnosis of insomnia disorder (Primary in nature) according to the Brief Insomnia Questionnaire (BIQ), a validated diagnostic tool. The criteria include having difficulties in falling asleep, difficulties in staying asleep, or early morning awakening with clinically significant consequences for daily life for at least 3 months;
- Insomnia Severity Index total score of at least 10 indicating insomnia at the clinical level;
- Willing to give informed consent and comply with the trial protocol;
- Ambulant and independent in activities of daily living;
- Physically inactive which refers to less than 150 minutes moderate-intensity activity per week or less than 75 minutes vigorous-intensity activity per week, or an equivalent combination of moderate- and vigorous- intensity activity.
Exclusion Criteria:
- Evidence of association of insomnia with medical conditions, other sleep disorders, or side-effects of medications;
- Use of medication or psychotherapeutic components for insomnia or other psychiatric disorders;
- Other possible psychiatric disorders including generalized anxiety disorder (GAD), major depressive disorder (MDD), posttraumatic stress disorder (PTSD), psychosis as screened by structural clinical interview of DSM-IV;
- cognitive impairment preventing informed consent or understanding of instructions (score < 22 in Montreal Cognitive Assessment Hong Kong version);
- Shift work;
- body mass index equal to or over 27.5, the obese criteria for Asians;
- Unsafe conditions or incapable to exercise as recommended by their physician.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Zero Time Exercise training
Subjects in this group will attend two 2-hour ZTEx training lessons.
Each subject will receive a handout and an exercise log.
The handout includes a picture-illustrating ZTEx step-by-step protocol.
The exercise log is for them to record their time spending on performing the ZTEx every day during the 8-week study period.
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Zero Time Exercise鼓励人们通过简单的、随时随地都可以做的运动来增加身体锻炼。
我们提供 2 节课的培训课程来训练受试者进行零时间锻炼。
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有源比较器：sleep hygiene education
Subjects in this group will receive two 2-hour lessons of sleep hygiene education delivered by a registered nurse.
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我们提供 2 节课的教育课程，教授有关睡眠卫生习惯的科目。
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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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Insomnia Severity Index
大体时间：week 8
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The subjects rate the severity of insomnia, the distress, and the functional impairment associated with insomnia on a 5-point
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week 8
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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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Sleep diary (7-day)
大体时间：Baseline, week 4, week 8
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The standardized sleep diary records the daily bedtime and rising time, from which the total time in bed (TIB) can be calculated.
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Baseline, week 4, week 8
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Multidimensional fatigue inventory-20
大体时间：Baseline, week 4, week 8
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Multidimensional fatigue inventory-20 is a 20-items self-report instrument designed to measure severity of fatigue.
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Baseline, week 4, week 8
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Hospital Anxiety and Depression Scale
大体时间：Baseline, week 4, week 8
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The Hospital Anxiety and Depression Scale is a 14-items self-administered questionnaire, which assesses the severity of depressive and anxiety symptoms
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Baseline, week 4, week 8
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Actigraphy (7-day)
大体时间：Baseline, week 8
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Actigraphy measures wrist movements to assess sleep or waking state, is accomplished through an accelerometer in a wrist worn device
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Baseline, week 8
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Short Form-6 Dimension
大体时间：Baseline, week 4, week 8
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The Short Form-6 Dimension is composed of six multi-level dimensions to assess the quality of life which can be used in cost-utility analysis.
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Baseline, week 4, week 8
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Hand grip strength
大体时间：Baseline, week 8
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Objective hand grip strength
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Baseline, week 8
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Level of activity
大体时间：Baseline, week4, week 8
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Self-report level of activity in moderate and vigorous intensity
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Baseline, week4, week 8
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Weight
大体时间：Baseline, week 8
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Weight in kilograms; (Weight and Height will be combined to report as BMI in kg/m^2)
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Baseline, week 8
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Height
大体时间：Baseline, week 8
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Height in meters; (Weight and Height will be combined to report as BMI in kg/m^2)
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Baseline, week 8
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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.
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