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
试验速览
- 阶段
- 不适用
- 入组人数
- 228
- 试验地点
- 2
- 主要终点
- Cognitive Tests: for executive function (2nd test)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
No information will be given to test administrators about intervention or control groups with the exception of project staff.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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 ).
结局指标
主要结局
Cognitive Tests: for executive function (2nd test)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- 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)
研究者
Chow Bik-chu
Professor
Hong Kong Baptist University