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

Insomnia, Primary Clinical Trial

Official title:

Effects of Messaging App Reminder on the Compliance of Zero-Time Exercise (ZTEx): A Nested Proof-of-concept Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04227574
• Other study ID #: WAM
• Status: Completed
• Phase: N/A
• Start date: January 31, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: September 2023
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Insomnia, Primary
• Sleep Initiation and Maintenance Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
Hong Kong	School of Nursing, the Hong Kong Polytechnic University	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	week 8, week 16, week 24
Primary	Change in the intervention adherence	Patients will be told to record their daily physical activities or sleep health hygiene compliance onto the log.	week 8, week 16, week 24
Secondary	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.	week 8, week 16, week 24
Secondary	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.	week 8, week 16, week 24
Secondary	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.	week 8, week 16, week 24
Secondary	Actigraphy (7-day)	Actigraphy measures wrist movements to assess sleep or waking state, is accomplished through an accelerometer in a wrist worn device.	week 8, week 16, week 24
Secondary	Accelerometer (7-day)	Accelerometer measures wrist movements to assess the physical activity levels.	week 8, week 16, week 24
Secondary	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.	week 8, week 16, week 24
Secondary	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.	week 8, week 16, week 24
Secondary	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.	week 8, week 16, week 24
Secondary	Change in the Hong Kong List Learning Test (HKLLT)	Change in HKLLT Test score will be used to measure the memory function.	week 8, week 16, week 24
Secondary	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.	week 8, week 16, week 24
Secondary	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	week 8, week 16, week 24
Secondary	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	week 8, week 16, week 24
Secondary	Change in the Wisconsin Card Sorting Test	Change in the Wisconsin Card Sorting Test score will be used to measure the executive function	week 8, week 16, week 24