Effects of Zero-Time Exercise (ZTEx) on Inactive Adults With Insomnia
NCT ID: NCT03155750
Last Updated: 2017-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
37 participants
INTERVENTIONAL
2017-06-05
2017-09-07
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Hypothesis: Subjects in the ZTEx training group will have greater improvement in insomnia symptoms and daytime impairment than those in the sleep hygiene education (SHE) group at week 8.
Design and subjects: A randomized controlled trial. 32 inactive subjects with insomnia disorder recruited from the community will be randomized to ZTEx training or SHE groups in a 1: 1 ratio.
Study instrument: Insomnia Severity Index (ISI) will be used to assess insomnia symptoms and daytime impairment.
Interventions: Subjects in the ZTEx training group will attend two training lessons (2-hour each) to learn ZTEx and practice it every night for 8 weeks; subjects in the SHE group will receive sleep hygiene education with the schedule and duration that are same to the ZTEx training group.
Main outcome measures: The primary outcome measure is the ISI score. Other measures include sleep parameters by subjective sleep diary and objective actigraphy, Hospital Anxiety and Depression Scale, Multidimensional Fatigue Inventory-20 and Short Form-6 Dimension. Acceptability and compliance of ZTEx will be evaluated.
Data Analysis: Differences in the questionnaire scores, subjective and objective sleep parameters will be examined using a mixed-effects model.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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 every day during the 8-week study period.
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.
sleep hygiene education
Subjects in this group will receive two 2-hour lessons of sleep hygiene education delivered by a registered nurse.
Sleep hygiene education
We offer a 2-session education course to teach the subjects about sleep hygiene practice.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Sleep hygiene education
We offer a 2-session education course to teach the subjects about sleep hygiene practice.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Chinese Hong Kong residents who are able to communicate in Cantonese or Mandarin;
* A current clinical Diagnostic and Statistical Manual of Mental Disorders-fifth edition (DSM-5) diagnosis of insomnia disorder (Primary in nature) according to the Brief Insomnia Questionnaire (BIQ), a validated diagnostic tool. The criteria include having difficulties in falling asleep, difficulties in staying asleep, or early morning awakening with clinically significant consequences for daily life for at least 3 months;
* Insomnia Severity Index total score of at least 10 indicating insomnia at the clinical level;
* Willing to give informed consent and comply with the trial protocol;
* Ambulant and independent in activities of daily living;
* Physically inactive which refers to less than 150 minutes moderate-intensity activity per week or less than 75 minutes vigorous-intensity activity per week, or an equivalent combination of moderate- and vigorous- intensity activity.
Exclusion Criteria
* Use of medication or psychotherapeutic components for insomnia or other psychiatric disorders;
* Other possible psychiatric disorders including generalized anxiety disorder (GAD), major depressive disorder (MDD), posttraumatic stress disorder (PTSD), psychosis as screened by structural clinical interview of DSM-IV;
* cognitive impairment preventing informed consent or understanding of instructions (score \< 22 in Montreal Cognitive Assessment Hong Kong version);
* Shift work;
* body mass index equal to or over 27.5, the obese criteria for Asians;
* Unsafe conditions or incapable to exercise as recommended by their physician.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Hong Kong Polytechnic University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
YEUNG Wing Fai
Assistant Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
School of Nursing, the Hong Kong Polytechnic University
Hong Kong, , Hong Kong
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Yeung WF, Lai AY, Ho FY, Suen LK, Chung KF, Ho JY, Ho LM, Yu BY, Chan LY, Lam TH. Effects of Zero-time Exercise on inactive adults with insomnia disorder: a pilot randomized controlled trial. Sleep Med. 2018 Dec;52:118-127. doi: 10.1016/j.sleep.2018.07.025. Epub 2018 Aug 24.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ZTEInsomnia
Identifier Type: -
Identifier Source: org_study_id