Effects of Zero-Time Exercise (ZTEx) on Inactive Adults With Insomnia
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|ClinicalTrials.gov Identifier: NCT03155750|
Recruitment Status : Completed
First Posted : May 16, 2017
Last Update Posted : October 20, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Insomnia, Primary||Other: Zero Time Exercise Other: Sleep hygiene education||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effects of Zero-Time Exercise (ZTEx) on Inactive Adults With Insomnia: A Pilot Randomized Controlled Trial|
|Actual Study Start Date :||June 5, 2017|
|Actual Primary Completion Date :||September 7, 2017|
|Actual Study Completion Date :||September 7, 2017|
Experimental: 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.
Other: Zero Time Exercise
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.
Active Comparator: sleep hygiene education
Subjects in this group will receive two 2-hour lessons of sleep hygiene education delivered by a registered nurse.
Other: Sleep hygiene education
We offer a 2-session education course to teach the subjects about sleep hygiene practice.
- Insomnia Severity Index [ Time Frame: week 8 ]The subjects rate the severity of insomnia, the distress, and the functional impairment associated with insomnia on a 5-point
- Sleep diary (7-day) [ Time Frame: Baseline, week 4, week 8 ]The standardized sleep diary records the daily bedtime and rising time, from which the total time in bed (TIB) can be calculated.
- Multidimensional fatigue inventory-20 [ Time Frame: Baseline, week 4, week 8 ]Multidimensional fatigue inventory-20 is a 20-items self-report instrument designed to measure severity of fatigue.
- Hospital Anxiety and Depression Scale [ Time Frame: Baseline, week 4, week 8 ]The Hospital Anxiety and Depression Scale is a 14-items self-administered questionnaire, which assesses the severity of depressive and anxiety symptoms
- Actigraphy (7-day) [ Time Frame: Baseline, week 8 ]Actigraphy measures wrist movements to assess sleep or waking state, is accomplished through an accelerometer in a wrist worn device
- Short Form-6 Dimension [ Time Frame: Baseline, week 4, week 8 ]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.
- Hand grip strength [ Time Frame: Baseline, week 8 ]Objective hand grip strength
- Level of activity [ Time Frame: Baseline, week4, week 8 ]Self-report level of activity in moderate and vigorous intensity
- Weight [ Time Frame: Baseline, week 8 ]Weight in kilograms; (Weight and Height will be combined to report as BMI in kg/m^2)
- Height [ Time Frame: Baseline, week 8 ]Height in meters; (Weight and Height will be combined to report as BMI in kg/m^2)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03155750
|School of Nursing, the Hong Kong Polytechnic University|
|Hong Kong, Hong Kong|