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

NCT04227587 | Completed

• 1 other identifier: ZTXI
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Insomnia, Primary

Keywords

insomnia

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, week 8, week 16, week 24

Secondary Outcomes (9)

• Sleep diary (7-day)

  baseline, week 8, week 16, week 24

• Hospital Anxiety and Depression Scale

  baseline, week 8, week 16, week 24

• Multidimensional fatigue inventory-20

  baseline, week 8, week 16, week 24

• Actigraphy (7-day)

  baseline, week 8, week 16, week 24

• Accelerometer (7-day)

  baseline, week 8, week 16, week 24

Other Outcomes (1)

• Intervention adherence (7 day)

  week 1-8, week 12-15, week 20-23

Study Arms (2)

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.

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.

Other: Sleep hygiene education

Interventions

Zero Time Exercise OTHER

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.

Zero Time Exercise training

Sleep hygiene education OTHER

We offer a 2-session education course to teach the subjects about sleep hygiene practice.

Sleep hygiene education

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

School of Nursing, the Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

Related Publications (1)

• 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.

  PMID: 39999728 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• WF Yeung

  School of Nursing, the Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 13, 2020
• Study Start: September 1, 2020
• Primary Completion: April 30, 2022
• Study Completion: June 30, 2022
• Last Updated: June 12, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)