Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2025-12-27 @ 8:32 PM
Study NCT ID:
NCT04727450
Status:
UNKNOWN
Last Update Posted:
2021-01-27
First Post:
2021-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Multimodal Training of Combined Cognitive and/or Physical Training on Cognition and Fitness of Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000091942', 'term': 'Cognitive Training'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}], 'ancestors': [{'id': 'D000066530', 'term': 'Neurological Rehabilitation'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'No information will be given to test administrators about intervention or control groups with the exception of project staff.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'Cluster RCT. Each elderly center as a cluster will be randomly assigned to be either an intervention group (IG) to receive intervention training modes (A: cognitive training, B: physical training only, C: CCPT) or a control group (CG). IGs will either receive integrated format of ABC or two training modes of AB or BC or CA.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 228}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2023-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-22', 'studyFirstSubmitDate': '2021-01-17', 'studyFirstSubmitQcDate': '2021-01-22', 'lastUpdatePostDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Behavioral and motivation survey (pre-test)', 'timeFrame': 'Pre-test (1st test): before intervention', 'description': 'Survey on motivation and subjective health status rating'}, {'measure': 'Behavioral and motivation survey (2nd test)', 'timeFrame': '2nd test: after 2-month intervention', 'description': 'Survey on motivation and subjective health status rating'}, {'measure': 'Behavioral and motivation survey (3rd test)', 'timeFrame': '3rd test: after 4-month intervention', 'description': 'Survey on motivation and subjective health status rating'}, {'measure': 'Behavioral and Motivation Survey (4th test)', 'timeFrame': '4th test: after 2-month follow up', 'description': 'Survey on motivation and subjective health status rating'}, {'measure': 'Depression and Loneliness Survey (pre-test)', 'timeFrame': 'Pre-test (1st test): before intervention', 'description': 'The Center for Epidemiological Studies-Depression scale (CES-D) and Loneliness'}, {'measure': 'Depression and Loneliness Survey (2nd test)', 'timeFrame': '2nd test: after 2-month intervention', 'description': 'The Center for Epidemiological Studies-Depression scale (CES-D) and Loneliness'}, {'measure': 'Depression and Loneliness Survey (3rd test)', 'timeFrame': '3rd test: after 4-month intervention', 'description': 'The Center for Epidemiological Studies-Depression scale (CES-D) and Loneliness'}, {'measure': 'Depression and Loneliness Survey (4th test)', 'timeFrame': '4th test: after 2-month follow up', 'description': 'The Center for Epidemiological Studies-Depression scale (CES-D) and Loneliness'}, {'measure': 'Physical activity participation Survey (pre-test)', 'timeFrame': 'Pre-test (1st test): before intervention', 'description': 'Physical activity participation (TTM)'}, {'measure': 'Physical activity participation Survey (2nd test)', 'timeFrame': '2nd test: after 2-month intervention', 'description': 'Physical activity participation (TTM)'}, {'measure': 'Physical activity participation Survey (3rd test)', 'timeFrame': '3rd test: after 4-month intervention', 'description': 'Physical activity participation (TTM)'}, {'measure': 'Physical activity participation Survey (4th test)', 'timeFrame': '4th test: after 2-month follow up', 'description': 'Physical activity participation (TTM)'}], 'primaryOutcomes': [{'measure': 'Cognitive Tests: for executive function (pre-test)', 'timeFrame': 'Pre-test (1st test): before intervention', 'description': 'Wisconsin Card Sorting Test (WCST) for the executive function will be conducted (20-30 min, unit on a scale) in four evaluation time frames, respectively. The evaluators at all sessions will be blind to the group membership of participants.'}, {'measure': 'Cognitive Tests: for executive function (2nd test)', 'timeFrame': '2nd test: after 2-month intervention', 'description': 'Wisconsin Card Sorting Test (WCST) for the executive function will be conducted (20-30 min, unit on a scale) in four evaluation time frames, respectively. The evaluators at all sessions will be blind to the group membership of participants.'}, {'measure': 'Cognitive Tests: for executive function (3rd test)', 'timeFrame': '3rd test: after 4-month intervention', 'description': 'Wisconsin Card Sorting Test (WCST) for the executive function will be conducted (20-30 min, unit on a scale) in four evaluation time frames, respectively. The evaluators at all sessions will be blind to the group membership of participants.'}, {'measure': 'Cognitive Tests: for executive function (4th test)', 'timeFrame': '4th test: after 2-month follow up', 'description': 'Wisconsin Card Sorting Test (WCST) for the executive function will be conducted (20-30 min, unit on a scale) in four evaluation time frames, respectively. The evaluators at all sessions will be blind to the group membership of participants.'}, {'measure': 'Cognitive Tests: for attention (pre-test)', 'timeFrame': 'Pre-test (1st test): before intervention', 'description': 'Color Trail Making test (CTMT) for attention will be conducted (5-8 min, unit on a scale) in four evaluation time frames, respectively. The evaluators at all sessions will be blind to the group membership of participants.'}, {'measure': 'Cognitive Tests: for attention (2nd test)', 'timeFrame': '2nd test: after 2-month intervention', 'description': 'Color Trail Making test (CTMT) for attention will be conducted (5-8 min, unit on a scale) in four evaluation time frames, respectively. The evaluators at all sessions will be blind to the group membership of participants.'}, {'measure': 'Cognitive Tests: for attention (3rd test)', 'timeFrame': '3rd test: after 4-month intervention', 'description': 'Color Trail Making test (CTMT) for attention will be conducted (5-8 min, unit on a scale) in four evaluation time frames, respectively. The evaluators at all sessions will be blind to the group membership of participants.'}, {'measure': 'Cognitive Tests: for attention (4th test)', 'timeFrame': '4th test: after 2-month follow up', 'description': 'Color Trail Making test (CTMT) for attention will be conducted (5-8 min, unit on a scale) in four evaluation time frames, respectively. The evaluators at all sessions will be blind to the group membership of participants.'}, {'measure': 'Cognitive Tests: for everyday memory (pre-test)', 'timeFrame': 'Pre-test (1st test): before intervention', 'description': 'Rivermead Behavioral Memory Test (RBMT) for everyday memory will be conducted (30 min, unit on a scale) in four evaluation time frames, respectively. The evaluators at all sessions will be blind to the group membership of participants.'}, {'measure': 'Cognitive Tests: for everyday memory (2nd test)', 'timeFrame': '2nd test: after 2-month intervention', 'description': 'Rivermead Behavioral Memory Test (RBMT) for everyday memory will be conducted (30 min, unit on a scale) in four evaluation time frames, respectively. The evaluators at all sessions will be blind to the group membership of participants.'}, {'measure': 'Cognitive Tests: for everyday memory (3rd test)', 'timeFrame': '3rd test: after 4-month intervention', 'description': 'Rivermead Behavioral Memory Test (RBMT) for everyday memory will be conducted (30 min, unit on a scale) in four evaluation time frames, respectively. The evaluators at all sessions will be blind to the group membership of participants.'}, {'measure': 'Cognitive Tests: for everyday memory (4th test)', 'timeFrame': '4th test: after 2-month follow up', 'description': 'Rivermead Behavioral Memory Test (RBMT) for everyday memory will be conducted (30 min, unit on a scale) in four evaluation time frames, respectively. The evaluators at all sessions will be blind to the group membership of participants.'}], 'secondaryOutcomes': [{'measure': 'Fitness Tests: BMI (pre-test)', 'timeFrame': 'Pre-test (1st test): before intervention', 'description': 'Weight and height will be tested and combined to report BMI in kg/m\\^2 in four evaluation time frames'}, {'measure': 'Fitness Tests: BMI (2nd test)', 'timeFrame': '2nd test: after 2-month intervention', 'description': 'Weight and height will be tested and combined to report BMI in kg/m\\^2 in four evaluation time frames'}, {'measure': 'Fitness Tests: BMI (3rd test)', 'timeFrame': '3rd test: after 4-month intervention', 'description': 'Weight and height will be tested and combined to report BMI in kg/m\\^2 in four evaluation time frames'}, {'measure': 'Fitness Tests: BMI (4th test)', 'timeFrame': '4th test: after 2-month follow up', 'description': 'Weight and height will be tested and combined to report BMI in kg/m\\^2 in four evaluation time frames'}, {'measure': 'Fitness Tests: Senior physical fitness test battery (pre-test)', 'timeFrame': 'Pre-test (1st test): before intervention', 'description': 'Senior physical fitness test'}, {'measure': 'Fitness Tests: Senior physical fitness test battery (2nd test)', 'timeFrame': '2nd test: after 2-month intervention', 'description': 'Senior physical fitness test'}, {'measure': 'Fitness Tests: Senior physical fitness test battery (3rd test)', 'timeFrame': '3rd test: after 4-month intervention', 'description': 'Senior physical fitness test'}, {'measure': 'Fitness Tests: Senior physical fitness test battery (4th test)', 'timeFrame': '4th test: after 2-month follow up', 'description': 'Senior physical fitness test'}, {'measure': 'Four square step test for dynamic balance (pre-test)', 'timeFrame': 'Pre-test (1st test): before intervention', 'description': 'Four square step test'}, {'measure': 'Four square step test for dynamic balance (2nd test)', 'timeFrame': '2nd test: after 2-month intervention', 'description': 'Four square step test'}, {'measure': 'Four square step test for dynamic balance (3rd test)', 'timeFrame': '3rd test: after 4-month intervention', 'description': 'Four square step test'}, {'measure': 'Four square step test for dynamic balance (4th test)', 'timeFrame': '4th test: after 2-month follow up', 'description': 'Four square step test'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intervention programs', 'Older adults', 'Cognitive & Physical Training', 'Cluster RCT', 'Multimodal'], 'conditions': ['Cognitive Decline', 'Cognitive Impairment, Mild']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Fu F, Chow BC. Brain Invigoration and Gross Motor Activation Programme (BIGMAP). Hong Kong Baptist University, Hong Kong. 2019. ISBN: 9789881542137'}, {'pmid': '35524188', 'type': 'DERIVED', 'citation': "Chow BC, Jiao J, Man D, Lippke S. Study protocol for 'the effects of multimodal training of cognitive and/or physical functions on cognition and physical fitness of older adults: a cluster randomized controlled trial'. BMC Geriatr. 2022 May 6;22(1):398. doi: 10.1186/s12877-022-03031-5."}]}, 'descriptionModule': {'briefSummary': 'The elderly population worldwide is expected to increase exponentially. There will be a higher percentage of older adults suffering cognitive decline in the coming decades. Cognitive impairment, being the most common health problem associated with ageing, contributes to possible loss of functional independence and disability. The purpose of this study is to determine the effectiveness of four mixed modalities of three training programs (combined cognitive and physical training \\[CCPT\\], cognitive or physical training only) on cognition and fitness of community-dwelling older adults in Hong Kong. The study hypotheses will be set as the integrated format of all three training will have higher cognition and fitness scores than other combinations of two training modes and all these mixed modalities will have greater positive outcomes than the active control subjects.', 'detailedDescription': 'The study design is a cluster randomized controlled trial. Twenty-four elderly centers as clusters will be randomly selected and assigned to be intervention (n=20) or control groups (n=4) in two study phases. A total of 8-10 older adults (age ≥ 60) from each cluster (total subjects = 228) will be invited to be study participants. Each intervention cluster will receive either an integrated training format or one out of three combinations of two training modes. Each intervention training mode will last for 2-month of 16 sessions in total, 2 sessions per week and 60 min per session, hence, the total intervention will last for 4 months for two training modes or an integrated training format. Assessments will be conducted at pre-test, two post-training tests, and a 2-month follow-up test after completion of all training.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age 60 or above\n2. Both gender\n3. Willingness and capability to participate in this study and training\n4. Willingness and capability to give informed consent to participate in this study\n5. Pass the cutting-point of referenced screening tests (cognitive and emotional)\n\nScreening tools:\n\n* MOCA score above 19 (satisfactory basic function)\n* Positive and Negative Syndrome Scale (PANSS) with scores \\< 19 in positive scale, \\< 22 in negative scale, and \\< 38 in general psychopathology scale\n\nExclusion Criteria:\n\n1. A history of systematic cardiovascular diseases, poorly controlled hypertension, stroke, Parkinson's disease\n2. Early stages of Alzheimer's Disease, or the use of psychoactive drugs\n3. Complicated conditions that preclude regular attendance of the training\n4. Currently receiving regular physical (perform aerobic, flexibility and stretching exercises for 3 days per week, 45 minutes per session, for 1 year or longer) and cognitive exercises (such as playing mahjong, chess, bridge and reading for more than 30 minutes per session and 3 times per week, for 1 year or longer )."}, 'identificationModule': {'nctId': 'NCT04727450', 'acronym': 'MTCCP', 'briefTitle': 'Effects of Multimodal Training of Combined Cognitive and/or Physical Training on Cognition and Fitness of Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'Hong Kong Baptist University'}, 'officialTitle': 'Effects of Multimodal Training of Combined Cognitive and Physical and Cognitive or Physical Training Only on Cognition and Physical Fitness of Older Adults: A Cluster Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '12607620'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1. Integrated format', 'description': 'Integrated or Combination of ABC of A: cognitive training. B: physical training and C: Combined Cognitive and Physical Training (CCPT).', 'interventionNames': ['Behavioral: Cognitive training', 'Behavioral: physical training', 'Behavioral: Combination of cognitive and physical training (CCPT)-BIGMAP']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2. Cognitive training + Physical Training (A+B)', 'description': 'Intervention of A \\& B treatments.', 'interventionNames': ['Behavioral: Cognitive training', 'Behavioral: physical training']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3. Physical training + CCPT (B+C)', 'description': 'Intervention of B \\& C treatments.', 'interventionNames': ['Behavioral: physical training', 'Behavioral: Combination of cognitive and physical training (CCPT)-BIGMAP']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4. CCPT + Cognitive training (C+A)', 'description': 'Intervention of C \\& A treatments.', 'interventionNames': ['Behavioral: Cognitive training', 'Behavioral: Combination of cognitive and physical training (CCPT)-BIGMAP']}, {'type': 'NO_INTERVENTION', 'label': '5. Control group', 'description': 'No intervention'}], 'interventions': [{'name': 'Cognitive training', 'type': 'BEHAVIORAL', 'description': 'Involves participants engaging in selected games which require thinking skills to be played in a group of 2-4 people.', 'armGroupLabels': ['1. Integrated format', '2. Cognitive training + Physical Training (A+B)', '4. CCPT + Cognitive training (C+A)']}, {'name': 'physical training', 'type': 'BEHAVIORAL', 'description': 'Involves learning of preselected routines of "line dancing" taught by a line dance instructor.', 'armGroupLabels': ['1. Integrated format', '2. Cognitive training + Physical Training (A+B)', '3. Physical training + CCPT (B+C)']}, {'name': 'Combination of cognitive and physical training (CCPT)-BIGMAP', 'type': 'BEHAVIORAL', 'otherNames': ['"Brain Invigoration Gross Motor Activation Program" (BIGMAP)'], 'description': 'BIGMAP is a program engaging participants in specially designed cognitive/memory games together with physical training (Fu \\& Chow, 2019).', 'armGroupLabels': ['1. Integrated format', '3. Physical training + CCPT (B+C)', '4. CCPT + Cognitive training (C+A)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00852', 'city': 'Hong Kong', 'country': 'Hong Kong', 'contacts': [{'name': 'Bik-Chu CHOW, PhD', 'role': 'CONTACT', 'email': 'bchow@hkbu.edu.hk', 'phone': '+85234117007'}, {'name': 'Jojo JIAO, PhD', 'role': 'CONTACT', 'email': 'jojojiao@hkbu.edu.hk', 'phone': '+85234115758'}, {'name': 'Bik-Chu CHOW, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sonia LIPPKE, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Wai-Kwong MAN, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hong Kong Baptist University', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Bik-Chu CHOW, PhD', 'role': 'CONTACT', 'email': 'bchow@hkbu.edu.hk', 'phone': '+85234117007'}, {'name': 'Jojo JIAO, PhD', 'role': 'CONTACT', 'email': 'jojojiao@hkbu.edu', 'phone': '+85234115758'}], 'overallOfficials': [{'name': 'Bik-Chu CHOW, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hong Kong Baptist University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'In our application of university human ethics, we have declared non-disclosure of individual data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hong Kong Baptist University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jacobs University Bremen gGmbH', 'class': 'OTHER'}, {'name': 'The Hong Kong Polytechnic University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Chow Bik-chu', 'investigatorAffiliation': 'Hong Kong Baptist University'}}}}