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

NCT ID: NCT04227587

Last Updated: 2023-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2022-06-30

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Zero Time Exercise training

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.

Group Type: EXPERIMENTAL

Zero Time Exercise

Intervention Type: 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.

Sleep hygiene education

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.

Group Type: ACTIVE_COMPARATOR

Sleep hygiene education

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Sleep hygiene education

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

Intervention Type: OTHER

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

YEUNG Wing Fai

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

WF Yeung

Role: PRINCIPAL_INVESTIGATOR

School of Nursing, the Hong Kong Polytechnic University

Locations

School of Nursing, the Hong Kong Polytechnic University

Hong Kong, , Hong Kong

Countries

Hong Kong

References

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.

Reference Type: DERIVED

PMID: 39999728 (View on PubMed)

Other Identifiers

ZTXI

Identifier Type: -

Identifier Source: org_study_id