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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zero Time Exercise training | Experimental | 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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| sleep hygiene education | Active Comparator | Subjects in this group will receive two 2-hour lessons of sleep hygiene education delivered by a registered nurse. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zero Time Exercise | Other | Zero Time Exercise encourage people to increase physical exercise by simple movements that can be done any time at any places. We offer a 2-session training course to train the subjects to do zero-time exercise. |
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia Severity Index | The subjects rate the severity of insomnia, the distress, and the functional impairment associated with insomnia on a 5-point | week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep diary (7-day) | The standardized sleep diary records the daily bedtime and rising time, from which the total time in bed (TIB) can be calculated. | Baseline, week 4, week 8 |
| Multidimensional fatigue inventory-20 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Nursing, the Hong Kong Polytechnic University | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30312957 | Derived | Yeung WF, Lai AY, Ho FY, Suen LK, Chung KF, Ho JY, Ho LM, Yu BY, Chan LY, Lam TH. Effects of Zero-time Exercise on inactive adults with insomnia disorder: a pilot randomized controlled trial. Sleep Med. 2018 Dec;52:118-127. doi: 10.1016/j.sleep.2018.07.025. Epub 2018 Aug 24. |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| Sleep hygiene education | Other | We offer a 2-session education course to teach the subjects about sleep hygiene practice. |
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Multidimensional fatigue inventory-20 is a 20-items self-report instrument designed to measure severity of fatigue.
| Baseline, week 4, week 8 |
| Hospital Anxiety and Depression Scale | The Hospital Anxiety and Depression Scale is a 14-items self-administered questionnaire, which assesses the severity of depressive and anxiety symptoms | Baseline, week 4, week 8 |
| Actigraphy (7-day) | Actigraphy measures wrist movements to assess sleep or waking state, is accomplished through an accelerometer in a wrist worn device | Baseline, week 8 |
| Short Form-6 Dimension | 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. | Baseline, week 4, week 8 |
| Hand grip strength | Objective hand grip strength | Baseline, week 8 |
| Level of activity | Self-report level of activity in moderate and vigorous intensity | Baseline, week4, week 8 |
| Weight | Weight in kilograms; (Weight and Height will be combined to report as BMI in kg/m^2) | Baseline, week 8 |
| Height | Height in meters; (Weight and Height will be combined to report as BMI in kg/m^2) | Baseline, week 8 |
| D001523 |
| Mental Disorders |