Effects of Zero-Time Exercise (ZTEx) on Inactive Adults With Insomnia: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Insomnia Severity Index
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Zero Time Exercise (Other)
sleep hygiene education
Subjects in this group will receive two 2-hour lessons of sleep hygiene education delivered by a registered nurse.
干预措施: Sleep hygiene education (Other)
结局指标
主要结局
Insomnia Severity Index
时间窗: week 8
The subjects rate the severity of insomnia, the distress, and the functional impairment associated with insomnia on a 5-point
次要结局
- Level of activity(Baseline, week4, week 8)
- Multidimensional fatigue inventory-20(Baseline, week 4, week 8)
- Actigraphy (7-day)(Baseline, week 8)
- Short Form-6 Dimension(Baseline, week 4, week 8)
- Hand grip strength(Baseline, week 8)
- Height(Baseline, week 8)
- Sleep diary (7-day)(Baseline, week 4, week 8)
- Hospital Anxiety and Depression Scale(Baseline, week 4, week 8)
- Weight(Baseline, week 8)
研究者
YEUNG Wing Fai
Assistant Professor
The Hong Kong Polytechnic University