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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
37
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.
We offer a 2-session education course to teach the subjects about sleep hygiene practice.
School of Nursing, the Hong Kong Polytechnic University
Hong Kong, Hong Kong
Insomnia Severity Index
The subjects rate the severity of insomnia, the distress, and the functional impairment associated with insomnia on a 5-point
Time frame: week 8
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.
Time frame: Baseline, week 4, week 8
Multidimensional fatigue inventory-20
Multidimensional fatigue inventory-20 is a 20-items self-report instrument designed to measure severity of fatigue.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Baseline, week 4, week 8
Hand grip strength
Objective hand grip strength
Time frame: Baseline, week 8
Level of activity
Self-report level of activity in moderate and vigorous intensity
Time frame: Baseline, week4, week 8
Weight
Weight in kilograms; (Weight and Height will be combined to report as BMI in kg/m\^2)
Time frame: Baseline, week 8
Height
Height in meters; (Weight and Height will be combined to report as BMI in kg/m\^2)
Time frame: Baseline, week 8
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