Effects of Messaging App Reminder on the Compliance of Zero-Time Exercise (ZTEx)
Primary Purpose
Insomnia, Primary
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Zero Time Exercise training + WhatsApp anti-inertia reminders
Zero Time Exercise training alone
Sponsored by
About this trial
This is an interventional other trial for Insomnia, Primary focused on measuring Insomnia
Eligibility Criteria
Inclusion Criteria:
- Hong Kong residents,
- ethnic Chinese aged 18-65 years with the ability to communicate in Cantonese or Putonghua,
- who fulfil the DSM-5 diagnostic criteria for insomnia disorder according to a validated diagnostic tool, the Brief Insomnia Questionnaire (we include primary insomnia because it is more homogenous and less complicated than comorbid insomnia; if ZTEx is found to be effective for primary insomnia, then comorbid insomnia can be targeted in future studies),
- scored at least 10 points in the Insomnia Severity Index,
- are ambulant and can independently perform daily activities,
- are physically inactive, defined as not having participated in at least 150 min of moderate intensity or 75 min of vigorous intensity physical activity a week, or the equivalent combination over the previous 3 months by self-report
- have a smartphone compatible with WhatsApp, and
- willing to give informed consent
Exclusion Criteria:
- any current diagnosis fulfilling the DSM-IV criteria of a major depressive disorder, generalized anxiety disorders, post-traumatic stress disorder, panic disorder, substance use disorders, or schizophrenia as screened using the Chinese version of the Structured Clinical Interview for DSM-IV;
- other sleep disorders, including circadian rhythm disorder, narcolepsy, obstructive sleep apnoea (OSA), and restless leg syndrome (RLS)/periodic leg movement disorder (PLMD) as determined based on cut-off scores (≥ 7 on narcolepsy; ≥ 8 on circadian rhythm disorder; ≥ 15 on OSA; ≥ 7 on RLS/PLMD) using SLEEP-50. If in doubt, subjects will be referred to our team psychiatrist (KF Chung) for further assessment;
- any current medical conditions or side-effects of medication that are contributing significantly to the subject's insomnia;
- taking medications or currently participating in other psychotherapies for insomnia or other psychiatric disorders;
- impaired cognitive functioning (<22 points in HK-MoCA) or with difficulty in giving consent or understanding instructions;
- pregnant;
- shift work;
- whose physical condition is such that physicians recommend that they refrain from exercising; and
- fulfilling the criterion for obesity for Asians (body mass index, of 27.5 or above)
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 + WhatsApp anti-inertia reminders
Zero Time Exercise training alone
Arm Description
Subjects in this group will receive daily WhatsApp anti-inertia reminders from the research assistant to remind and encourage them to practice Zero Time Exercise.
Subjects in this group will not receive any WhatsApp reminders from week 8 to 24.
Outcomes
Primary Outcome Measures
Change in Insomnia Severity Index
The subjects rate the severity of insomnia, the distress, and the functional impairment associated with insomnia on a 5-point scale. The score ranges from 0 to 28. The higher the score, the worse the outcome is.
Change in the intervention adherence
Patients will be told to record their daily physical activities or sleep health hygiene compliance onto the log.
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.
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. The score ranges from 0-21 for either depression or anxiety. The higher the score, the worse the outcome is.
Multidimensional fatigue inventory-20
Multidimensional fatigue inventory-20 is a 20-items self-report instrument designed to measure severity of fatigue. The score ranges from 20 to 100. The higher the score, the worse the outcome is.
Actigraphy (7-day)
Actigraphy measures wrist movements to assess sleep or waking state, is accomplished through an accelerometer in a wrist worn device.
Accelerometer (7-day)
Accelerometer measures wrist movements to assess the physical activity levels.
Change in WAIS-IV Digit Span forward test
Change in Wechsler Adult Intelligence Scale, 4th edition (WAIS-IV) Digit Span forward test score will be used to measure the attention function.
Change in WAIS-IV Color Trails Test
Change in Wechsler Adult Intelligence Scale, 4th edition (WAIS-IV) Color Trails Test score will be used to measure the attention function.
Change in WAIS-IV Stroop color-word Test
Change in Wechsler Adult Intelligence Scale, 4th edition (WAIS-IV) Stroop color-word Test score will be used to measure the attention function.
Change in the Hong Kong List Learning Test (HKLLT)
Change in HKLLT Test score will be used to measure the memory function.
Change in Digit Span-backward and forward test
Change in Digit Span-backward and forward test score will be used to measure the memory function.
Change in the interference index of Color Trails Test
Change in the interference index of Color Trails Test score will be used to measure the executive function
Change in the interference index of Stroop color-word Test
Change in the interference index of Stroop color-word Test score will be used to measure the executive function
Change in the Wisconsin Card Sorting Test
Change in the Wisconsin Card Sorting Test score will be used to measure the executive function
Full Information
NCT ID
NCT04227574
First Posted
January 6, 2020
Last Updated
September 23, 2023
Sponsor
The Hong Kong Polytechnic University
1. Study Identification
Unique Protocol Identification Number
NCT04227574
Brief Title
Effects of Messaging App Reminder on the Compliance of Zero-Time Exercise (ZTEx)
Official Title
Effects of Messaging App Reminder on the Compliance of Zero-Time Exercise (ZTEx): A Nested Proof-of-concept Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 31, 2020 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
June 30, 2023 (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
This is a proof-of-concept pilot nested in the RCT titled, 'Zero-time Exercise on Inactive Adults With Insomnia Disorder'. It aims to evaluate the effects of a simple WhatsApp intervention on exercise adherence and on sleep and related outcomes.
Detailed Description
This is the second phase of another study - 'Zero-time Exercise on Inactive Adults With Insomnia Disorder'.
In the first phase (baseline to week 8), 136 subjects will be randomly allocated to the ZTEx intervention or the sleep hygiene education (SHE) comparison group. They will receive two 2-hour ZTEx training or SHE lessons and practice ZTEx or follow the sleep hygiene instruction for 24 weeks.
The second phase of the study (weeks 9-24)will commence after completion of the assessment of the RCT at week 8. Subjects in the Zero-time Exercise (ZTEx) group will be randomly divided into either an ZTEx with WhatsApp reminder (ZTEx+R) group or an ZTEx without WhatsApp reminder (ZTEx alone) group to evaluate the effects of WhatsApp reminders on exercise adherence and sleep and related outcomes.
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
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Zero Time Exercise training + WhatsApp anti-inertia reminders
Arm Type
Experimental
Arm Description
Subjects in this group will receive daily WhatsApp anti-inertia reminders from the research assistant to remind and encourage them to practice Zero Time Exercise.
Arm Title
Zero Time Exercise training alone
Arm Type
Active Comparator
Arm Description
Subjects in this group will not receive any WhatsApp reminders from week 8 to 24.
Intervention Type
Other
Intervention Name(s)
Zero Time Exercise training + WhatsApp anti-inertia reminders
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.
In addition, WhatsApp anti-inertia reminders will be sent daily by the research assistant to remind and encourage the participants to practice the Zero Time Exercise.
Intervention Type
Other
Intervention Name(s)
Zero Time Exercise training alone
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.
Primary Outcome Measure Information:
Title
Change in Insomnia Severity Index
Description
The subjects rate the severity of insomnia, the distress, and the functional impairment associated with insomnia on a 5-point scale. The score ranges from 0 to 28. The higher the score, the worse the outcome is.
Time Frame
week 8, week 16, week 24
Title
Change in the intervention adherence
Description
Patients will be told to record their daily physical activities or sleep health hygiene compliance onto the log.
Time Frame
week 8, week 16, week 24
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
week 8, week 16, week 24
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. The score ranges from 0-21 for either depression or anxiety. The higher the score, the worse the outcome is.
Time Frame
week 8, week 16, week 24
Title
Multidimensional fatigue inventory-20
Description
Multidimensional fatigue inventory-20 is a 20-items self-report instrument designed to measure severity of fatigue. The score ranges from 20 to 100. The higher the score, the worse the outcome is.
Time Frame
week 8, week 16, week 24
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
week 8, week 16, week 24
Title
Accelerometer (7-day)
Description
Accelerometer measures wrist movements to assess the physical activity levels.
Time Frame
week 8, week 16, week 24
Title
Change in WAIS-IV Digit Span forward test
Description
Change in Wechsler Adult Intelligence Scale, 4th edition (WAIS-IV) Digit Span forward test score will be used to measure the attention function.
Time Frame
week 8, week 16, week 24
Title
Change in WAIS-IV Color Trails Test
Description
Change in Wechsler Adult Intelligence Scale, 4th edition (WAIS-IV) Color Trails Test score will be used to measure the attention function.
Time Frame
week 8, week 16, week 24
Title
Change in WAIS-IV Stroop color-word Test
Description
Change in Wechsler Adult Intelligence Scale, 4th edition (WAIS-IV) Stroop color-word Test score will be used to measure the attention function.
Time Frame
week 8, week 16, week 24
Title
Change in the Hong Kong List Learning Test (HKLLT)
Description
Change in HKLLT Test score will be used to measure the memory function.
Time Frame
week 8, week 16, week 24
Title
Change in Digit Span-backward and forward test
Description
Change in Digit Span-backward and forward test score will be used to measure the memory function.
Time Frame
week 8, week 16, week 24
Title
Change in the interference index of Color Trails Test
Description
Change in the interference index of Color Trails Test score will be used to measure the executive function
Time Frame
week 8, week 16, week 24
Title
Change in the interference index of Stroop color-word Test
Description
Change in the interference index of Stroop color-word Test score will be used to measure the executive function
Time Frame
week 8, week 16, week 24
Title
Change in the Wisconsin Card Sorting Test
Description
Change in the Wisconsin Card Sorting Test score will be used to measure the executive function
Time Frame
week 8, week 16, week 24
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:
Hong Kong residents,
ethnic Chinese aged 18-65 years with the ability to communicate in Cantonese or Putonghua,
who fulfil the DSM-5 diagnostic criteria for insomnia disorder according to a validated diagnostic tool, the Brief Insomnia Questionnaire (we include primary insomnia because it is more homogenous and less complicated than comorbid insomnia; if ZTEx is found to be effective for primary insomnia, then comorbid insomnia can be targeted in future studies),
scored at least 10 points in the Insomnia Severity Index,
are ambulant and can independently perform daily activities,
are physically inactive, defined as not having participated in at least 150 min of moderate intensity or 75 min of vigorous intensity physical activity a week, or the equivalent combination over the previous 3 months by self-report
have a smartphone compatible with WhatsApp, and
willing to give informed consent
Exclusion Criteria:
any current diagnosis fulfilling the DSM-IV criteria of a major depressive disorder, generalized anxiety disorders, post-traumatic stress disorder, panic disorder, substance use disorders, or schizophrenia as screened using the Chinese version of the Structured Clinical Interview for DSM-IV;
other sleep disorders, including circadian rhythm disorder, narcolepsy, obstructive sleep apnoea (OSA), and restless leg syndrome (RLS)/periodic leg movement disorder (PLMD) as determined based on cut-off scores (≥ 7 on narcolepsy; ≥ 8 on circadian rhythm disorder; ≥ 15 on OSA; ≥ 7 on RLS/PLMD) using SLEEP-50. If in doubt, subjects will be referred to our team psychiatrist (KF Chung) for further assessment;
any current medical conditions or side-effects of medication that are contributing significantly to the subject's insomnia;
taking medications or currently participating in other psychotherapies for insomnia or other psychiatric disorders;
impaired cognitive functioning (<22 points in HK-MoCA) or with difficulty in giving consent or understanding instructions;
pregnant;
shift work;
whose physical condition is such that physicians recommend that they refrain from exercising; and
fulfilling the criterion for obesity for Asians (body mass index, of 27.5 or above)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
WF Yeung
Organizational Affiliation
School of Nursing, the Hong Kong Polytechnic University
Official's Role
Principal Investigator
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
Learn more about this trial
Effects of Messaging App Reminder on the Compliance of Zero-Time Exercise (ZTEx)
We'll reach out to this number within 24 hrs