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| Name | Class |
|---|---|
| Jacobs University Bremen gGmbH | OTHER |
| The Hong Kong Polytechnic University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. Integrated format | Active Comparator | Integrated or Combination of ABC of A: cognitive training. B: physical training and C: Combined Cognitive and Physical Training (CCPT). |
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| 2. Cognitive training + Physical Training (A+B) | Active Comparator | Intervention of A & B treatments. |
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| 3. Physical training + CCPT (B+C) | Active Comparator | Intervention of B & C treatments. |
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| 4. CCPT + Cognitive training (C+A) | Active Comparator | Intervention of C & A treatments. |
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| 5. Control group | No Intervention | No intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive training | Behavioral | Involves participants engaging in selected games which require thinking skills to be played in a group of 2-4 people. |
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| Measure | Description | Time Frame |
|---|---|---|
| Cognitive Tests: for executive function (pre-test) | 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. | Pre-test (1st test): before intervention |
| Cognitive Tests: for executive function (2nd test) | 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. | 2nd test: after 2-month intervention |
| Cognitive Tests: for executive function (3rd test) | 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. | 3rd test: after 4-month intervention |
| Cognitive Tests: for executive function (4th test) | 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. | 4th test: after 2-month follow up |
| Cognitive Tests: for attention (pre-test) | 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. | Pre-test (1st test): before intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Fitness Tests: BMI (pre-test) | Weight and height will be tested and combined to report BMI in kg/m^2 in four evaluation time frames | Pre-test (1st test): before intervention |
| Fitness Tests: BMI (2nd test) |
| Measure | Description | Time Frame |
|---|---|---|
| Behavioral and motivation survey (pre-test) | Survey on motivation and subjective health status rating | Pre-test (1st test): before intervention |
| Behavioral and motivation survey (2nd test) | Survey on motivation and subjective health status rating |
Inclusion Criteria:
Screening tools:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bik-Chu CHOW, PhD | Contact | +85234117007 | bchow@hkbu.edu.hk | |
| Jojo JIAO, PhD | Contact | +85234115758 | jojojiao@hkbu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Bik-Chu CHOW, PhD | Hong Kong Baptist University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hong Kong Baptist University | Hong Kong | 00852 | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Fu F, Chow BC. Brain Invigoration and Gross Motor Activation Programme (BIGMAP). Hong Kong Baptist University, Hong Kong. 2019. ISBN: 9789881542137 | ||
| 35524188 | Derived | 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. |
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In our application of university human ethics, we have declared non-disclosure of individual data.
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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.
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No information will be given to test administrators about intervention or control groups with the exception of project staff.
| physical training | Behavioral | Involves learning of preselected routines of "line dancing" taught by a line dance instructor. |
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| Combination of cognitive and physical training (CCPT)-BIGMAP | Behavioral | BIGMAP is a program engaging participants in specially designed cognitive/memory games together with physical training (Fu & Chow, 2019). |
|
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| Cognitive Tests: for attention (2nd test) | 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. | 2nd test: after 2-month intervention |
| Cognitive Tests: for attention (3rd test) | 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. | 3rd test: after 4-month intervention |
| Cognitive Tests: for attention (4th test) | 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. | 4th test: after 2-month follow up |
| Cognitive Tests: for everyday memory (pre-test) | 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. | Pre-test (1st test): before intervention |
| Cognitive Tests: for everyday memory (2nd test) | 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. | 2nd test: after 2-month intervention |
| Cognitive Tests: for everyday memory (3rd test) | 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. | 3rd test: after 4-month intervention |
| Cognitive Tests: for everyday memory (4th test) | 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. | 4th test: after 2-month follow up |
Weight and height will be tested and combined to report BMI in kg/m^2 in four evaluation time frames
| 2nd test: after 2-month intervention |
| Fitness Tests: BMI (3rd test) | Weight and height will be tested and combined to report BMI in kg/m^2 in four evaluation time frames | 3rd test: after 4-month intervention |
| Fitness Tests: BMI (4th test) | Weight and height will be tested and combined to report BMI in kg/m^2 in four evaluation time frames | 4th test: after 2-month follow up |
| Fitness Tests: Senior physical fitness test battery (pre-test) | Senior physical fitness test | Pre-test (1st test): before intervention |
| Fitness Tests: Senior physical fitness test battery (2nd test) | Senior physical fitness test | 2nd test: after 2-month intervention |
| Fitness Tests: Senior physical fitness test battery (3rd test) | Senior physical fitness test | 3rd test: after 4-month intervention |
| Fitness Tests: Senior physical fitness test battery (4th test) | Senior physical fitness test | 4th test: after 2-month follow up |
| Four square step test for dynamic balance (pre-test) | Four square step test | Pre-test (1st test): before intervention |
| Four square step test for dynamic balance (2nd test) | Four square step test | 2nd test: after 2-month intervention |
| Four square step test for dynamic balance (3rd test) | Four square step test | 3rd test: after 4-month intervention |
| Four square step test for dynamic balance (4th test) | Four square step test | 4th test: after 2-month follow up |
| 2nd test: after 2-month intervention |
| Behavioral and motivation survey (3rd test) | Survey on motivation and subjective health status rating | 3rd test: after 4-month intervention |
| Behavioral and Motivation Survey (4th test) | Survey on motivation and subjective health status rating | 4th test: after 2-month follow up |
| Depression and Loneliness Survey (pre-test) | The Center for Epidemiological Studies-Depression scale (CES-D) and Loneliness | Pre-test (1st test): before intervention |
| Depression and Loneliness Survey (2nd test) | The Center for Epidemiological Studies-Depression scale (CES-D) and Loneliness | 2nd test: after 2-month intervention |
| Depression and Loneliness Survey (3rd test) | The Center for Epidemiological Studies-Depression scale (CES-D) and Loneliness | 3rd test: after 4-month intervention |
| Depression and Loneliness Survey (4th test) | The Center for Epidemiological Studies-Depression scale (CES-D) and Loneliness | 4th test: after 2-month follow up |
| Physical activity participation Survey (pre-test) | Physical activity participation (TTM) | Pre-test (1st test): before intervention |
| Physical activity participation Survey (2nd test) | Physical activity participation (TTM) | 2nd test: after 2-month intervention |
| Physical activity participation Survey (3rd test) | Physical activity participation (TTM) | 3rd test: after 4-month intervention |
| Physical activity participation Survey (4th test) | Physical activity participation (TTM) | 4th test: after 2-month follow up |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000091942 | Cognitive Training |
| D064797 | Physical Conditioning, Human |
| ID | Term |
|---|---|
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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