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

Primary Purpose

Insomnia, Primary

Status

Completed

Phase

Not Applicable

Locations

Hong Kong

Study Type

Interventional

Intervention

Zero Time Exercise

Sleep hygiene education

About this trial

This is an interventional treatment trial for Insomnia, Primary focused on measuring insomnia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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)

Sites / Locations

School of Nursing, the Hong Kong Polytechnic University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Zero Time Exercise training

Sleep hygiene education

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

Actigraphy (7-day)

Actigraphy measures wrist movements to assess sleep or waking state, is accomplished through an accelerometer in a wrist worn device.

Accelerometer (7-day)

Accelerometer measures wrist movements to assess the physical activity levels.

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.

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.

Change in Digit Span-backward test

Change in Digit Span-backward and forward test score will be used to measure the memory function.

Change in the Wisconsin Card Sorting Test

Change in the Wisconsin Card Sorting Test score will be used to measure the executive function

Full Information

NCT ID

NCT04227587

First Posted

January 6, 2020

Last Updated

June 9, 2023

Sponsor

The Hong Kong Polytechnic University

1. Study Identification

Unique Protocol Identification Number

NCT04227587

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

September 1, 2020 (Actual)

Primary Completion Date

April 30, 2022 (Actual)

Study Completion Date

June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Hong Kong Polytechnic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Insomnia, Primary

Keywords

insomnia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

140 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Zero Time Exercise training

Arm Type

Experimental

Arm Description

Arm Title

Sleep hygiene education

Arm Type

Active Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

Zero Time Exercise

Intervention Description

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

Intervention Name(s)

Sleep hygiene education

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in the Insomnia Severity Index score

Description

Time Frame

Baseline, week 8, week 16, week 24

Secondary Outcome Measure Information:

Title

Sleep diary (7-day)

Description

The standardized sleep diary records the daily bedtime and rising time, from which the total time in bed (TIB) can be calculated.

Time Frame