Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2026-01-03 @ 6:58 PM
Study NCT ID:
NCT03155750
Status:
COMPLETED
Last Update Posted:
2017-10-20
First Post:
2017-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Zero-Time Exercise (ZTEx) on Inactive Adults With Insomnia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-09-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-18', 'studyFirstSubmitDate': '2017-05-14', 'studyFirstSubmitQcDate': '2017-05-15', 'lastUpdatePostDateStruct': {'date': '2017-10-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insomnia Severity Index', 'timeFrame': 'week 8', 'description': 'The subjects rate the severity of insomnia, the distress, and the functional impairment associated with insomnia on a 5-point'}], 'secondaryOutcomes': [{'measure': 'Sleep diary (7-day)', 'timeFrame': 'Baseline, week 4, week 8', 'description': 'The standardized sleep diary records the daily bedtime and rising time, from which the total time in bed (TIB) can be calculated.'}, {'measure': 'Multidimensional fatigue inventory-20', 'timeFrame': 'Baseline, week 4, week 8', 'description': 'Multidimensional fatigue inventory-20 is a 20-items self-report instrument designed to measure severity of fatigue.'}, {'measure': 'Hospital Anxiety and Depression Scale', 'timeFrame': 'Baseline, week 4, week 8', 'description': 'The Hospital Anxiety and Depression Scale is a 14-items self-administered questionnaire, which assesses the severity of depressive and anxiety symptoms'}, {'measure': 'Actigraphy (7-day)', 'timeFrame': 'Baseline, week 8', 'description': 'Actigraphy measures wrist movements to assess sleep or waking state, is accomplished through an accelerometer in a wrist worn device'}, {'measure': 'Short Form-6 Dimension', 'timeFrame': 'Baseline, week 4, week 8', 'description': 'The Short Form-6 Dimension is composed of six multi-level dimensions to assess the quality of life which can be used in cost-utility analysis.'}, {'measure': 'Hand grip strength', 'timeFrame': 'Baseline, week 8', 'description': 'Objective hand grip strength'}, {'measure': 'Level of activity', 'timeFrame': 'Baseline, week4, week 8', 'description': 'Self-report level of activity in moderate and vigorous intensity'}, {'measure': 'Weight', 'timeFrame': 'Baseline, week 8', 'description': 'Weight in kilograms; (Weight and Height will be combined to report as BMI in kg/m\\^2)'}, {'measure': 'Height', 'timeFrame': 'Baseline, week 8', 'description': 'Height in meters; (Weight and Height will be combined to report as BMI in kg/m\\^2)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['insomnia'], 'conditions': ['Insomnia, Primary']}, 'referencesModule': {'references': [{'pmid': '30312957', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'Objectives: To evaluate the clinical effects of Zero-Time Exercise (ZTEx) for treating insomnia disorder delivered by a training course.\n\nHypothesis: 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.\n\nDesign 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.\n\nStudy instrument: Insomnia Severity Index (ISI) will be used to assess insomnia symptoms and daytime impairment.\n\nInterventions: 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.\n\nMain 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.\n\nData Analysis: Differences in the questionnaire scores, subjective and objective sleep parameters will be examined using a mixed-effects model.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults age 18-65 years old;\n* Chinese Hong Kong residents who are able to communicate in Cantonese or Mandarin;\n* 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;\n* Insomnia Severity Index total score of at least 10 indicating insomnia at the clinical level;\n* Willing to give informed consent and comply with the trial protocol;\n* Ambulant and independent in activities of daily living;\n* 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.\n\nExclusion Criteria:\n\n* Evidence of association of insomnia with medical conditions, other sleep disorders, or side-effects of medications;\n* Use of medication or psychotherapeutic components for insomnia or other psychiatric disorders;\n* 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;\n* cognitive impairment preventing informed consent or understanding of instructions (score \\< 22 in Montreal Cognitive Assessment Hong Kong version);\n* Shift work;\n* body mass index equal to or over 27.5, the obese criteria for Asians;\n* Unsafe conditions or incapable to exercise as recommended by their physician.'}, 'identificationModule': {'nctId': 'NCT03155750', 'briefTitle': 'Effects of Zero-Time Exercise (ZTEx) on Inactive Adults With Insomnia', 'organization': {'class': 'OTHER', 'fullName': 'The Hong Kong Polytechnic University'}, 'officialTitle': 'Effects of Zero-Time Exercise (ZTEx) on Inactive Adults With Insomnia: A Pilot Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'ZTEInsomnia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Zero Time Exercise training', '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 every day during the 8-week study period.', 'interventionNames': ['Other: Zero Time Exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'sleep hygiene education', 'description': 'Subjects in this group will receive two 2-hour lessons of sleep hygiene education delivered by a registered nurse.', 'interventionNames': ['Other: Sleep hygiene education']}], 'interventions': [{'name': 'Zero Time Exercise', 'type': 'OTHER', '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.', 'armGroupLabels': ['Zero Time Exercise training']}, {'name': 'Sleep hygiene education', 'type': 'OTHER', 'description': 'We offer a 2-session education course to teach the subjects about sleep hygiene practice.', 'armGroupLabels': ['sleep hygiene education']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'School of Nursing, the Hong Kong Polytechnic University', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hong Kong Polytechnic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'YEUNG Wing Fai', 'investigatorAffiliation': 'The Hong Kong Polytechnic University'}}}}