Insomnia, PrimaryNCT04227587

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

A study testing Zero Time Exercise and Sleep hygiene education in people with Insomnia, Primary, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Insomnia, Primary
What is being tested?: Zero Time Exercise and Sleep hygiene education
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 140 participants
Where: 1 siteHong Kong
Study dates: 1 Sep 2020to 30 Jun 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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;

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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)

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

School of Nursing, the Hong Kong Polytechnic University
Hong Kong

Other trials in Hong Kong

About this study

Official title: Zero-time Exercise on Inactive Adults With Insomnia Disorder: A Randomized Controlled Trial and Mixed-method Process Evaluation

Read the detailed description

This randomized controlled trial (RCT) with a longitudinal mixed-method process evaluation aims to (1) determine the effectiveness of a ZTEx intervention program, which is a lifestyle-integrated physical activity program, on sleep and related outcomes in inactive adults with insomnia disorder; (2) identify the facilitators and barriers of ZTEx adherence, (3) explore the possible mechanisms of impact on ZTEx adherence and the same abovementioned outcomes.

This RCT consists of two phases. 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. After assessment at week 8, for the second phase of the study (weeks 9-24), which is a proof-of-concept pilot nested in the RCT, subjects in the ZTEx group will be randomly divided into either an ZTEx with WhatsApp reminder (ZTEx+R) subgroup or an ZTEx without WhatsApp reminder (ZTEx alone) subgroup to evaluate the effects of WhatsApp reminders on exercise adherence and the same outcomes. Mixed methods process evaluation will be conducted. Post-training and post-follow-up qualitative focus group interviews will be conducted; facilitators, barriers, and mediators will be analyzed.

Conditions: Insomnia, Primary
Being tested: Zero Time Exercise, Sleep hygiene education
Keywords: insomnia
Medical subject headings: Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Zero Time ExerciseOther
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.
Sleep hygiene educationOther
We offer a 2-session education course to teach the subjects about sleep hygiene practice.

Study groups in NCT04227587
Study group	Role	What they receive
Zero Time Exercise training	Experimental	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. Receives: Other: Zero Time Exercise
Sleep hygiene education	Active comparator	Subjects in this group will receive two 2-hour lessons of sleep hygiene education delivered by a registered nurse. Each subject will receive a handout and a sleep hygiene log.Subjects will be told to record their daily compliance with sleep hygiene instructions using yes/no questions in the sleep hygiene log. Receives: Other: Sleep hygiene education

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in the Insomnia Severity Index score
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.
Measured: Baseline, week 8, week 16, week 24

Secondary outcomes (9)

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.
Measured: baseline, week 8, week 16, week 24
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 between 0 and 21 for either anxiety or depression. The higher the score, the worse the outcome is.
Measured: baseline, week 8, week 16, week 24
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.
Measured: baseline, week 8, week 16, week 24
Actigraphy (7-day)
Actigraphy measures wrist movements to assess sleep or waking state, is accomplished through an accelerometer in a wrist worn device.
Measured: baseline, week 8, week 16, week 24
Accelerometer (7-day)
Accelerometer measures wrist movements to assess the physical activity levels.
Measured: baseline, week 8, week 16, week 24
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.
Measured: baseline, week 8, week 16, week 24
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.
Measured: baseline, week 8, week 16, week 24
Change in Digit Span-backward test
Change in Digit Span-backward and forward test score will be used to measure the memory function.
Measured: baseline, week 8, week 16, week 24
Change in the Wisconsin Card Sorting Test
Change in the Wisconsin Card Sorting Test score will be used to measure the executive function
Measured: baseline, week 8, week 16, week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 202030 Jun 2022

First posted13 Jan 2020
Study start1 Sep 2020
Primary completion30 Apr 2022
Study completion30 Jun 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Insomnia, PrimaryStudies of the same condition, open and under way.
More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 140 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04227587
Sponsor's protocol ID: ZTXI
Status last verified: Jun 2023
First submitted: 6 Jan 2020
Last updated: 12 Jun 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Yeung WF, Lai AY, Yu BY, Ho FY, Chung KF, Ho JY, Suen LK, Ho LM, Lam TH. Effect of zero-time exercise on physically inactive adults with insomnia disorder: A randomized controlled trial. Int J Nurs Stud. 2025 May;165:105033. doi: 10.1016/j.ijnurstu.2025.105033. Epub 2025 Feb 18.
PubMed 39999728

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Zero-time Exercise on Inactive Adults With Insomnia Disorder: A Randomized Controlled Trial and Mixed-method Process Evaluation
ClinicalTrials.gov ID: NCT04227587
Acronym / sponsor ID: ZTXI
Conditions: Insomnia, Primary
Keywords: insomnia
Study type: Interventional
Recruitment status: Completed
Enrolment: 140 participants (actual)
Lead sponsor: The Hong Kong Polytechnic UniversityUniversity, hospital or other
Study start: 1 Sep 2020 (actual)
Primary completion: 30 Apr 2022 (actual)
Study completion: 30 Jun 2022 (actual)
First posted: 13 Jan 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Zero Time Exercise training	Experimental	Other: Zero Time ExerciseSubjects 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.
Sleep hygiene education	Active comparator	Other: Sleep hygiene educationSubjects in this group will receive two 2-hour lessons of sleep hygiene education delivered by a registered nurse. Each subject will receive a handout and a sleep hygiene log.Subjects will be told to record their daily compliance with sleep hygiene instructions using yes/no questions in the sleep hygiene log.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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,

Key exclusion criteria (9 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Zero Time ExerciseZero 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.	Other	Zero Time Exercise training
Sleep hygiene educationWe offer a 2-session education course to teach the subjects about sleep hygiene practice.	Other	Sleep hygiene education

Primary outcome

Change in the Insomnia Severity Index score
Time frame: Baseline, 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.

9 secondary outcomes

Sleep diary (7-day)
Time frame: baseline, week 8, week 16, week 24
Hospital Anxiety and Depression Scale
Time frame: baseline, week 8, week 16, week 24
Multidimensional fatigue inventory-20
Time frame: baseline, week 8, week 16, week 24
Actigraphy (7-day)
Time frame: baseline, week 8, week 16, week 24
Accelerometer (7-day)
Time frame: baseline, week 8, week 16, week 24
Change in WAIS-IV Color Trails Test
Time frame: baseline, week 8, week 16, week 24
Change in WAIS-IV Stroop color-word Test
Time frame: baseline, week 8, week 16, week 24
Change in Digit Span-backward test
Time frame: baseline, week 8, week 16, week 24
Change in the Wisconsin Card Sorting Test
Time frame: baseline, week 8, week 16, week 24

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
Derived from this study: PubMed 39999728Yeung WF, Lai AY, Yu BY, Ho FY, Chung KF, Ho JY, Suen LK, Ho LM, Lam TH. Effect of zero-time exercise on physically inactive adults with insomnia disorder: A randomized controlled trial. Int J Nurs Stud. 2025 May;165:105033. doi: 10.1016/j.ijnurstu.2025.105033. Epub 2025 Feb 18.
Individual participant dataSharing planned: No

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Active, not recruiting
Active Coping: Interdisciplinary Program for Chronic Pain, Physiotherapy Unit (Spain)
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Not yet recruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

WF Yeung principal investigator

School of Nursing, the Hong Kong Polytechnic University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Zero Time Exercise and Sleep hygiene education in people with Insomnia, Primary, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the Insomnia Severity Index score (time frame: Baseline, week 8, week 16, week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04227587, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2023.