Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2026-01-14 @ 11:42 AM
Study NCT ID:
NCT05396092
Status:
UNKNOWN
Last Update Posted:
2022-05-31
First Post:
2022-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of an Integrated Mindfulness-based Tai Chi Chuan Program on Sleep Disturbance Among Community-dwelling Elderly People
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D026302', 'term': 'Tai Ji'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 256}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2025-04-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-24', 'studyFirstSubmitDate': '2022-05-17', 'studyFirstSubmitQcDate': '2022-05-24', 'lastUpdatePostDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'the Chinese (Hong Kong) Short-Form-12', 'timeFrame': 'at baseline (T1)', 'description': 'A higher respective summary score indicates better levels of health.'}, {'measure': 'the Chinese (Hong Kong) Short-Form-12', 'timeFrame': 'In the 8th week from baseline (T2)', 'description': 'A higher respective summary score indicates better levels of health.'}, {'measure': 'the Chinese (Hong Kong) Short-Form-12', 'timeFrame': 'six months after T2 (T3)', 'description': 'A higher respective summary score indicates better levels of health.'}, {'measure': 'the Chinese (Hong Kong) Short-Form-12', 'timeFrame': 'one year after T2 (T4)', 'description': 'A higher respective summary score indicates better levels of health.'}, {'measure': 'the rumination subscale from the Rumination-Reflection Questionnaire', 'timeFrame': 'at baseline (T1)', 'description': 'A higher score suggests greater ruminative tendencies.'}, {'measure': 'the rumination subscale from the Rumination-Reflection Questionnaire', 'timeFrame': 'In the 8th week from baseline (T2)', 'description': 'A higher score suggests greater ruminative tendencies.'}, {'measure': 'the rumination subscale from the Rumination-Reflection Questionnaire', 'timeFrame': 'six months after T2 (T3)', 'description': 'A higher score suggests greater ruminative tendencies.'}, {'measure': 'the rumination subscale from the Rumination-Reflection Questionnaire', 'timeFrame': 'one year after T2 (T4)', 'description': 'A higher score suggests greater ruminative tendencies.'}, {'measure': 'the hyperarousal scale', 'timeFrame': 'at baseline (T1)', 'description': 'A higher score suggests a higher arousal level.'}, {'measure': 'the hyperarousal scale', 'timeFrame': 'In the 8th week from baseline (T2)', 'description': 'A higher score suggests a higher arousal level.'}, {'measure': 'the hyperarousal scale', 'timeFrame': 'six months after T2 (T3)', 'description': 'A higher score suggests a higher arousal level.'}, {'measure': 'the hyperarousal scale', 'timeFrame': 'one year after T2 (T4)', 'description': 'A higher score suggests a higher arousal level.'}], 'primaryOutcomes': [{'measure': 'the Insomnia Severity Index', 'timeFrame': 'at baseline (T1)', 'description': 'This is a seven-item self-report questionnaire. A higher score represents greater insomnia severity.'}, {'measure': 'the Insomnia Severity Index', 'timeFrame': 'In the 8th week from baseline (T2)', 'description': 'This is a seven-item self-report questionnaire. A higher score represents greater insomnia severity.'}, {'measure': 'the Insomnia Severity Index', 'timeFrame': 'six months after T2 (T3)', 'description': 'This is a seven-item self-report questionnaire. A higher score represents greater insomnia severity.'}, {'measure': 'the Insomnia Severity Index', 'timeFrame': 'one year after T2 (T4)', 'description': 'This is a seven-item self-report questionnaire. A higher score represents greater insomnia severity.'}], 'secondaryOutcomes': [{'measure': 'the Multidimensional Assessment of Interoceptive Awareness scale', 'timeFrame': 'at baseline (T1)', 'description': 'The scale consists of 32 items and comprises eight subscales. A higher score indicates higher levels of interoceptive awareness.'}, {'measure': 'the Multidimensional Assessment of Interoceptive Awareness scale', 'timeFrame': 'In the 8th week from baseline (T2)', 'description': 'The scale consists of 32 items and comprises eight subscales. A higher score indicates higher levels of interoceptive awareness.'}, {'measure': 'the Multidimensional Assessment of Interoceptive Awareness scale', 'timeFrame': 'six months after T2 (T3)', 'description': 'The scale consists of 32 items and comprises eight subscales. A higher score indicates higher levels of interoceptive awareness.'}, {'measure': 'the Multidimensional Assessment of Interoceptive Awareness scale', 'timeFrame': 'one year after T2 (T4)', 'description': 'The scale consists of 32 items and comprises eight subscales. A higher score indicates higher levels of interoceptive awareness.'}, {'measure': 'Wrist ActiGraph GT9X (ActiGraph, Pensacola, USA)', 'timeFrame': 'at baseline (T1)', 'description': 'Participants will be asked to put on this ActiGraph GT9X (like a watch) on the wrist of the non-dominant hand for one week. Wrist ActiGraph GT9X is used to assess the average total sleep time (hours) per night.'}, {'measure': 'Wrist ActiGraph GT9X (ActiGraph, Pensacola, USA)', 'timeFrame': 'In the 8th week from baseline (T2)', 'description': 'Participants will be asked to put on this ActiGraph GT9X (like a watch) on the wrist of the non-dominant hand for one week. Wrist ActiGraph GT9X is used to assess the average total sleep time (hours) per night.'}, {'measure': 'Wrist ActiGraph GT9X (ActiGraph, Pensacola, USA)', 'timeFrame': 'six months after T2 (T3)', 'description': 'Participants will be asked to put on this ActiGraph GT9X (like a watch) on the wrist of the non-dominant hand for one week. Wrist ActiGraph GT9X is used to assess the average total sleep time (hours) per night.'}, {'measure': 'Wrist ActiGraph GT9X (ActiGraph, Pensacola, USA)', 'timeFrame': 'one year after T2 (T4)', 'description': 'Participants will be asked to put on this ActiGraph GT9X (like a watch) on the wrist of the non-dominant hand for one week. Wrist ActiGraph GT9X is used to assess the average total sleep time (hours) per night.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Elderly', 'Sleep', 'Mindfulness', 'Tai Chi Chuan']}, 'referencesModule': {'references': [{'pmid': '36153623', 'type': 'DERIVED', 'citation': 'Chan SH, Ng SM, Yu CH, Chan CM, Wang SM, Chan WC. The effects of an integrated mindfulness-based tai chi chuan programme on sleep disturbance among community-dwelling elderly people: protocol for a randomized controlled trial. Trials. 2022 Sep 24;23(1):808. doi: 10.1186/s13063-022-06737-4.'}]}, 'descriptionModule': {'briefSummary': 'The trial aims to evaluate the effects of an integrated form of mindfulness-based Tai Chi Chuan (MBTCC) program and the underlying mechanisms of the beneficial effects on sleep disturbance over 12-month follow-up in community-dwelling elderly people.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Aged 60 years or above;\n* Classified as experiencing sleep disturbances (indication of poor sleep quality through a score \\>5 in the Pittsburgh Sleep Quality Index);\n* Primary education level or above and able to communicate in Cantonese;\n* Able to give informed consent; and\n* No previous experience with meditation or other mind-body techniques (e.g., tai chi or yoga).\n\nExclusion criteria:\n\n• Comorbid diagnoses of schizophrenia, schizoaffective disorder, substance misuse, organic brain syndrome, or intellectual disabilities.'}, 'identificationModule': {'nctId': 'NCT05396092', 'acronym': 'MBTCC', 'briefTitle': 'The Effects of an Integrated Mindfulness-based Tai Chi Chuan Program on Sleep Disturbance Among Community-dwelling Elderly People', 'organization': {'class': 'OTHER', 'fullName': 'The Hong Kong Polytechnic University'}, 'officialTitle': 'The Effects of an Integrated Mindfulness-based Tai Chi Chuan Program on Sleep Disturbance Among Community-dwelling Elderly People: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'HSEARS20210331002-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Integrated mindfulness-based Tai Chi Chuan', 'description': 'MBTCC', 'interventionNames': ['Behavioral: Integrated mindfulness-based Tai Chi Chuan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mindfulness-based intervention', 'description': 'MBI', 'interventionNames': ['Behavioral: Mindfulness-based intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tai Chi Chuan', 'description': 'TCC', 'interventionNames': ['Behavioral: Tai Chi Chuan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sleep Hygiene Education', 'description': 'SHE', 'interventionNames': ['Behavioral: Sleep Hygiene Education']}], 'interventions': [{'name': 'Integrated mindfulness-based Tai Chi Chuan', 'type': 'BEHAVIORAL', 'otherNames': ['MBTCC'], 'description': 'MBTCC will integrate components from both the MBI and TCC groups. The entire intervention consists of eight weekly sessions of two-and-a-half to three hours each.', 'armGroupLabels': ['Integrated mindfulness-based Tai Chi Chuan']}, {'name': 'Mindfulness-based intervention', 'type': 'BEHAVIORAL', 'otherNames': ['MBI'], 'description': 'The MBI group is mainly based on the basic theory and research of the foundational mindfulness-based stress reduction program. The intervention consists of eight weekly sessions of two to two-and-a-half hours each.', 'armGroupLabels': ['Mindfulness-based intervention']}, {'name': 'Tai Chi Chuan', 'type': 'BEHAVIORAL', 'otherNames': ['TCC'], 'description': 'TCC is mainly based on a nine-form Yang-style form of TCC, which is a brief and modified version of 64-form Yang-style TCC. The entire intervention consists of eight weekly sessions of two to two-and-a-half hours each.', 'armGroupLabels': ['Tai Chi Chuan']}, {'name': 'Sleep Hygiene Education', 'type': 'BEHAVIORAL', 'otherNames': ['SHE'], 'description': 'SHE is based on principles used in stimulus control and sleep hygiene education, which has previously been used as the control group in sleep-related research. The entire intervention consists of eight weekly sessions of two to two-and-a-half hours each.', 'armGroupLabels': ['Sleep Hygiene Education']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kowloon', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Shu-Mei Wang, PhD', 'role': 'CONTACT', 'email': 'shumei.wang@polyu.edu.hk', 'phone': '852-27664197'}], 'facility': 'Hong Kong Polytechnic University', 'geoPoint': {'lat': 22.31667, 'lon': 114.18333}}], 'centralContacts': [{'name': 'Shu-Mei Wang, PhD', 'role': 'CONTACT', 'email': 'shumei.wang@polyu.edu.hk', 'phone': '852-27664197'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hong Kong Polytechnic University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Food and Health Bureau, Hong Kong', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}