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Trial record 10 of 6064 for:    zero

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

Tracking Information
First Submitted Date  ICMJE May 14, 2017
First Posted Date  ICMJE May 16, 2017
Last Update Posted Date October 20, 2017
Actual Study Start Date  ICMJE June 5, 2017
Actual Primary Completion Date September 7, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03155750 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2017)
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2017)
  • 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 invenstory-20 [ Time Frame: Baseline, week 4, week 8 ]
    MFI-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 HADS 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
  • SF-6D [ Time Frame: Baseline, week 4, week 8 ]
    The SF-6D is composed of six multi-level dimensions to assess the quality of life which can be used in cost-utility analysis.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Zero-Time Exercise (ZTEx) on Inactive Adults With Insomnia
Official Title  ICMJE Effects of Zero-Time Exercise (ZTEx) on Inactive Adults With Insomnia: A Pilot Randomized Controlled Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Insomnia, Primary
Intervention  ICMJE
  • 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.
  • Other: Sleep hygiene education
    We offer a 2-session education course to teach the subjects about sleep hygiene practice.
Study Arms  ICMJE
  • 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.
    Intervention: Other: 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.
    Intervention: Other: Sleep hygiene education
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 17, 2017)
37
Original Estimated Enrollment  ICMJE
 (submitted: May 15, 2017)
32
Actual Study Completion Date  ICMJE September 7, 2017
Actual Primary Completion Date September 7, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03155750
Other Study ID Numbers  ICMJE ZTEInsomnia
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party YEUNG Wing Fai, The Hong Kong Polytechnic University
Study Sponsor  ICMJE The Hong Kong Polytechnic University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The Hong Kong Polytechnic University
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP