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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
Sponsor:
Information provided by (Responsible Party):
YEUNG Wing Fai, The Hong Kong Polytechnic University

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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.

  6. Hand grip strength [ Time Frame: Baseline, week 8 ]
    Objective hand grip strength

  7. Level of activity [ Time Frame: Baseline, week4, week 8 ]
    Self-report level of activity in moderate and vigorous intensity

  8. Weight [ Time Frame: Baseline, week 8 ]
    Weight in kilograms; (Weight and Height will be combined to report as BMI in kg/m^2)

  9. Height [ Time Frame: Baseline, week 8 ]
    Height in meters; (Weight and Height will be combined to report as BMI in kg/m^2)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Hong Kong
School of Nursing, the Hong Kong Polytechnic University
Hong Kong, Hong Kong
Sponsors and Collaborators
The Hong Kong Polytechnic University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: YEUNG Wing Fai, Assistant Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT03155750     History of Changes
Other Study ID Numbers: ZTEInsomnia
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by YEUNG Wing Fai, The Hong Kong Polytechnic University:
insomnia
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders