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Effects of Zero-Time Exercise (ZTEx) on Inactive Adults With Insomnia

Primary Purpose

Insomnia, Primary

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Zero Time Exercise
Sleep hygiene education
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia, Primary focused on measuring insomnia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • School of Nursing, the Hong Kong Polytechnic University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Zero Time Exercise training

sleep hygiene education

Arm Description

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.

Subjects in this group will receive two 2-hour lessons of sleep hygiene education delivered by a registered nurse.

Outcomes

Primary Outcome Measures

Insomnia Severity Index
The subjects rate the severity of insomnia, the distress, and the functional impairment associated with insomnia on a 5-point

Secondary Outcome Measures

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.
Multidimensional fatigue inventory-20
Multidimensional fatigue inventory-20 is a 20-items self-report instrument designed to measure severity of fatigue.
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
Actigraphy (7-day)
Actigraphy measures wrist movements to assess sleep or waking state, is accomplished through an accelerometer in a wrist worn device
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.
Hand grip strength
Objective hand grip strength
Level of activity
Self-report level of activity in moderate and vigorous intensity
Weight
Weight in kilograms; (Weight and Height will be combined to report as BMI in kg/m^2)
Height
Height in meters; (Weight and Height will be combined to report as BMI in kg/m^2)

Full Information

First Posted
May 14, 2017
Last Updated
October 18, 2017
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT03155750
Brief Title
Effects of Zero-Time Exercise (ZTEx) on Inactive Adults With Insomnia
Official Title
Effects of Zero-Time Exercise (ZTEx) on Inactive Adults With Insomnia: A Pilot Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
June 5, 2017 (Actual)
Primary Completion Date
September 7, 2017 (Actual)
Study Completion Date
September 7, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Primary
Keywords
insomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zero Time Exercise training
Arm Type
Experimental
Arm Description
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.
Arm Title
sleep hygiene education
Arm Type
Active Comparator
Arm Description
Subjects in this group will receive two 2-hour lessons of sleep hygiene education delivered by a registered nurse.
Intervention Type
Other
Intervention Name(s)
Zero Time Exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sleep hygiene education
Intervention Description
We offer a 2-session education course to teach the subjects about sleep hygiene practice.
Primary Outcome Measure Information:
Title
Insomnia Severity Index
Description
The subjects rate the severity of insomnia, the distress, and the functional impairment associated with insomnia on a 5-point
Time Frame
week 8
Secondary Outcome Measure Information:
Title
Sleep diary (7-day)
Description
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
Title
Multidimensional fatigue inventory-20
Description
Multidimensional fatigue inventory-20 is a 20-items self-report instrument designed to measure severity of fatigue.
Time Frame
Baseline, week 4, week 8
Title
Hospital Anxiety and Depression Scale
Description
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
Title
Actigraphy (7-day)
Description
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
Title
Short Form-6 Dimension
Description
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
Title
Hand grip strength
Description
Objective hand grip strength
Time Frame
Baseline, week 8
Title
Level of activity
Description
Self-report level of activity in moderate and vigorous intensity
Time Frame
Baseline, week4, week 8
Title
Weight
Description
Weight in kilograms; (Weight and Height will be combined to report as BMI in kg/m^2)
Time Frame
Baseline, week 8
Title
Height
Description
Height in meters; (Weight and Height will be combined to report as BMI in kg/m^2)
Time Frame
Baseline, week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
School of Nursing, the Hong Kong Polytechnic University
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30312957
Citation
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.
Results Reference
derived

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Effects of Zero-Time Exercise (ZTEx) on Inactive Adults With Insomnia

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