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Trial record 2 of 6793 for:    zero

Effects of Messaging App Reminder on the Compliance of Zero-Time Exercise (ZTEx)

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ClinicalTrials.gov Identifier: NCT04227574
Recruitment Status : Not yet recruiting
First Posted : January 13, 2020
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
YEUNG Wing Fai, The Hong Kong Polytechnic University

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.

Condition or disease Intervention/treatment Phase
Insomnia, Primary Other: Zero Time Exercise training + WhatsApp anti-inertia reminders Other: Zero Time Exercise training alone Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Effects of Messaging App Reminder on the Compliance of Zero-Time Exercise (ZTEx): A Nested Proof-of-concept Pilot Study
Estimated Study Start Date : January 31, 2020
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Zero Time Exercise training + WhatsApp anti-inertia reminders
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.
Other: Zero Time Exercise training + WhatsApp anti-inertia reminders

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.


Active Comparator: Zero Time Exercise training alone
Subjects in this group will not receive any WhatsApp reminders from week 8 to 24.
Other: Zero Time Exercise training alone
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 Measures :
  1. Change in Insomnia Severity Index [ Time Frame: week 8, week 16, week 24 ]
    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.

  2. Change in the intervention adherence [ Time Frame: week 8, week 16, week 24 ]
    Patients will be told to record their daily physical activities or sleep health hygiene compliance onto the log.


Secondary Outcome Measures :
  1. Sleep diary (7-day) [ Time Frame: week 8, week 16, week 24 ]
    The standardized sleep diary records the daily bedtime and rising time, from which the total time in bed (TIB) can be calculated.

  2. Hospital Anxiety and Depression Scale [ Time Frame: week 8, week 16, week 24 ]
    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.

  3. Multidimensional fatigue inventory-20 [ Time Frame: week 8, week 16, week 24 ]
    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.

  4. Actigraphy (7-day) [ Time Frame: week 8, week 16, week 24 ]
    Actigraphy measures wrist movements to assess sleep or waking state, is accomplished through an accelerometer in a wrist worn device.

  5. Accelerometer (7-day) [ Time Frame: week 8, week 16, week 24 ]
    Accelerometer measures wrist movements to assess the physical activity levels.

  6. Change in WAIS-IV Digit Span forward test [ Time Frame: week 8, week 16, week 24 ]
    Change in Wechsler Adult Intelligence Scale, 4th edition (WAIS-IV) Digit Span forward test score will be used to measure the attention function.

  7. Change in WAIS-IV Color Trails Test [ Time Frame: week 8, week 16, week 24 ]
    Change in Wechsler Adult Intelligence Scale, 4th edition (WAIS-IV) Color Trails Test score will be used to measure the attention function.

  8. Change in WAIS-IV Stroop color-word Test [ Time Frame: week 8, week 16, week 24 ]
    Change in Wechsler Adult Intelligence Scale, 4th edition (WAIS-IV) Stroop color-word Test score will be used to measure the attention function.

  9. Change in the Hong Kong List Learning Test (HKLLT) [ Time Frame: week 8, week 16, week 24 ]
    Change in HKLLT Test score will be used to measure the memory function.

  10. Change in Digit Span-backward and forward test [ Time Frame: week 8, week 16, week 24 ]
    Change in Digit Span-backward and forward test score will be used to measure the memory function.

  11. Change in the interference index of Color Trails Test [ Time Frame: week 8, week 16, week 24 ]
    Change in the interference index of Color Trails Test score will be used to measure the executive function

  12. Change in the interference index of Stroop color-word Test [ Time Frame: week 8, week 16, week 24 ]
    Change in the interference index of Stroop color-word Test score will be used to measure the executive function

  13. Change in the Wisconsin Card Sorting Test [ Time Frame: week 8, week 16, week 24 ]
    Change in the Wisconsin Card Sorting Test score will be used to measure the executive function



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:

  1. Hong Kong residents,
  2. ethnic Chinese aged 18-65 years with the ability to communicate in Cantonese or Putonghua,
  3. 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),
  4. scored at least 10 points in the Insomnia Severity Index,
  5. are ambulant and can independently perform daily activities,
  6. 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
  7. have a smartphone compatible with WhatsApp, and
  8. willing to give informed consent

Exclusion Criteria:

  1. 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;
  2. 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;
  3. any current medical conditions or side-effects of medication that are contributing significantly to the subject's insomnia;
  4. taking medications or currently participating in other psychotherapies for insomnia or other psychiatric disorders;
  5. impaired cognitive functioning (<22 points in HK-MoCA) or with difficulty in giving consent or understanding instructions;
  6. pregnant;
  7. shift work;
  8. whose physical condition is such that physicians recommend that they refrain from exercising; and
  9. fulfilling the criterion for obesity for Asians (body mass index, of 27.5 or above)

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): NCT04227574


Contacts
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Contact: WF Yeung (852) 2766 4151 jerry-wf.yeung@polyu.edu.hk

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
Investigators
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Principal Investigator: WF Yeung School of Nursing, the Hong Kong Polytechnic University

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Responsible Party: YEUNG Wing Fai, Assistant Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT04227574    
Other Study ID Numbers: WAM
First Posted: January 13, 2020    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
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