School of Nursing, the Hong Kong Polytechnic University
Hong Kong
NCT Number: NCT04227574
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Hong Kong
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
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.
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.
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.
Time frame: week 8, week 16, week 24
Accelerometer measures wrist movements to assess the physical activity levels.
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.
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.
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.
Time frame: week 8, week 16, week 24
Change in HKLLT Test score will be used to measure the memory function.
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.
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
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
Time frame: week 8, week 16, week 24
Change in the Wisconsin Card Sorting Test score will be used to measure the executive function
The Hong Kong Polytechnic University
Other
Effects of Messaging App Reminder on the Compliance of Zero-Time Exercise (ZTEx): A Nested Proof-of-concept Pilot Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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