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
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Hong Kong Baptist University
- Enrollment
- 228
- Locations
- 1
- Primary Endpoint
- Cognitive Tests: for executive function (2nd test)
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Masking Description
No information will be given to test administrators about intervention or control groups with the exception of project staff.
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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 ).
Arms & Interventions
1. Integrated format
Integrated or Combination of ABC of A: cognitive training. B: physical training and C: Combined Cognitive and Physical Training (CCPT).
Intervention: Cognitive training (Behavioral)
1. Integrated format
Integrated or Combination of ABC of A: cognitive training. B: physical training and C: Combined Cognitive and Physical Training (CCPT).
Intervention: physical training (Behavioral)
1. Integrated format
Integrated or Combination of ABC of A: cognitive training. B: physical training and C: Combined Cognitive and Physical Training (CCPT).
Intervention: Combination of cognitive and physical training (CCPT)-BIGMAP (Behavioral)
2. Cognitive training + Physical Training (A+B)
Intervention of A & B treatments.
Intervention: Cognitive training (Behavioral)
2. Cognitive training + Physical Training (A+B)
Intervention of A & B treatments.
Intervention: physical training (Behavioral)
3. Physical training + CCPT (B+C)
Intervention of B & C treatments.
Intervention: physical training (Behavioral)
3. Physical training + CCPT (B+C)
Intervention of B & C treatments.
Intervention: Combination of cognitive and physical training (CCPT)-BIGMAP (Behavioral)
4. CCPT + Cognitive training (C+A)
Intervention of C & A treatments.
Intervention: Cognitive training (Behavioral)
4. CCPT + Cognitive training (C+A)
Intervention of C & A treatments.
Intervention: Combination of cognitive and physical training (CCPT)-BIGMAP (Behavioral)
5. Control group
No intervention
Outcomes
Primary Outcomes
Cognitive Tests: for executive function (2nd test)
Time Frame: 2nd test: after 2-month intervention
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.
Cognitive Tests: for executive function (3rd test)
Time Frame: 3rd test: after 4-month intervention
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.
Cognitive Tests: for executive function (4th test)
Time Frame: 4th test: after 2-month follow up
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.
Cognitive Tests: for attention (pre-test)
Time Frame: Pre-test (1st test): before intervention
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.
Cognitive Tests: for attention (2nd test)
Time Frame: 2nd test: after 2-month intervention
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.
Cognitive Tests: for attention (3rd test)
Time Frame: 3rd test: after 4-month intervention
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.
Cognitive Tests: for attention (4th test)
Time Frame: 4th test: after 2-month follow up
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.
Cognitive Tests: for everyday memory (pre-test)
Time Frame: Pre-test (1st test): before intervention
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.
Cognitive Tests: for everyday memory (2nd test)
Time Frame: 2nd test: after 2-month intervention
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.
Cognitive Tests: for everyday memory (3rd test)
Time Frame: 3rd test: after 4-month intervention
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.
Cognitive Tests: for everyday memory (4th test)
Time Frame: 4th test: after 2-month follow up
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.
Cognitive Tests: for executive function (pre-test)
Time Frame: Pre-test (1st test): before intervention
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.
Secondary Outcomes
- Fitness Tests: BMI (pre-test)(Pre-test (1st test): before intervention)
- Fitness Tests: BMI (2nd test)(2nd test: after 2-month intervention)
- Fitness Tests: BMI (3rd test)(3rd test: after 4-month intervention)
- Fitness Tests: BMI (4th test)(4th test: after 2-month follow up)
- Fitness Tests: Senior physical fitness test battery (pre-test)(Pre-test (1st test): before intervention)
- Fitness Tests: Senior physical fitness test battery (2nd test)(2nd test: after 2-month intervention)
- Fitness Tests: Senior physical fitness test battery (3rd test)(3rd test: after 4-month intervention)
- Fitness Tests: Senior physical fitness test battery (4th test)(4th test: after 2-month follow up)
- Four square step test for dynamic balance (pre-test)(Pre-test (1st test): before intervention)
- Four square step test for dynamic balance (2nd test)(2nd test: after 2-month intervention)
- Four square step test for dynamic balance (3rd test)(3rd test: after 4-month intervention)
- Four square step test for dynamic balance (4th test)(4th test: after 2-month follow up)
Investigators
Chow Bik-chu
Professor
Hong Kong Baptist University