Effects of Multimodal Training of Combined Cognitive and/or Physical Training on Cognition and Fitness of Older Adults

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Cognitive Decline, Cognitive Impairment, Mild

Intervention / Treatment
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* Behavioral: Cognitive training
* Behavioral: physical training
* Behavioral: Combination of cognitive and physical training (CCPT)-BIGMAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 60 or above Both gender Willingness and capability to participate in this study and training Willingness and capability to give informed consent to participate in this study Pass the cutting-point of referenced screening tests (cognitive and emotional) Screening tools: MOCA score above 19 (satisfactory basic function) Positive and Negative Syndrome Scale (PANSS) with scores < 19 in positive scale, < 22 in negative scale, and < 38 in general psychopathology scale Exclusion Criteria: A history of systematic cardiovascular diseases, poorly controlled hypertension, stroke, Parkinson's disease Early stages of Alzheimer's Disease, or the use of psychoactive drugs Complicated conditions that preclude regular attendance of the training 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 ).

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1. Integrated format<br>Integrated or Combination of ABC of A: cognitive training. B: physical training and C: Combined Cognitive and Physical Training (CCPT). | Behavioral: Cognitive training<br>* Involves participants engaging in selected games which require thinking skills to be played in a group of 2-4 people.<br>Behavioral: physical training<br>* Involves learning of preselected routines of line dancing taught by a line dance instructor.<br>Behavioral: Combination of cognitive and physical training (CCPT)-BIGMAP<br>* BIGMAP is a program engaging participants in specially designed cognitive/memory games together with physical training (Fu & Chow, 2019).<br>* Other names: Brain Invigoration Gross Motor Activation Program (BIGMAP);|
| Active Comparator: 2. Cognitive training + Physical Training (A+B)<br>Intervention of A & B treatments. | Behavioral: Cognitive training<br>* Involves participants engaging in selected games which require thinking skills to be played in a group of 2-4 people.<br>Behavioral: physical training<br>* Involves learning of preselected routines of line dancing taught by a line dance instructor.<br>|
| Active Comparator: 3. Physical training + CCPT (B+C)<br>Intervention of B & C treatments. | Behavioral: physical training<br>* Involves learning of preselected routines of line dancing taught by a line dance instructor.<br>Behavioral: Combination of cognitive and physical training (CCPT)-BIGMAP<br>* BIGMAP is a program engaging participants in specially designed cognitive/memory games together with physical training (Fu & Chow, 2019).<br>* Other names: Brain Invigoration Gross Motor Activation Program (BIGMAP);|
| Active Comparator: 4. CCPT + Cognitive training (C+A)<br>Intervention of C & A treatments. | Behavioral: Cognitive training<br>* Involves participants engaging in selected games which require thinking skills to be played in a group of 2-4 people.<br>Behavioral: Combination of cognitive and physical training (CCPT)-BIGMAP<br>* BIGMAP is a program engaging participants in specially designed cognitive/memory games together with physical training (Fu & Chow, 2019).<br>* Other names: Brain Invigoration Gross Motor Activation Program (BIGMAP);|
| No Intervention: 5. Control group<br>No intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intervention programs, Older adults, Cognitive & Physical Training, Cluster RCT, Multimodal