Clinical trial NCT04727450: Effects of Multimodal Training of Combined Cognitive and/or Physical Training on Cognition and Fitness of Older Adults
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cognitive Decline
Cognitive Impairment, Mild
Keywords: Intervention programs
Older adults
Cognitive & Physical Training
Cluster RCT
Multimodal
Lead sponsor: Hong Kong Baptist University
Sponsor class: OTHER
Collaborators: name: Jacobs University Bremen gGmbH
name: The Hong Kong Polytechnic University
First posted: 2021-01-27
Enrollment: 228
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention 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.
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

1. Age 60 or above
2. Both gender
3. Willingness and capability to participate in this study and training
4. Willingness and capability to give informed consent to participate in this study
5. 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:

1. A history of systematic cardiovascular diseases, poorly controlled hypertension, stroke, Parkinson's disease
2. Early stages of Alzheimer's Disease, or the use of psychoactive drugs
3. Complicated conditions that preclude regular attendance of the training
4. 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 ).

Primary outcomes:
measure: Cognitive Tests: for executive function (pre-test)
timeFrame: Pre-test (1st test): before intervention
measure: Cognitive Tests: for executive function (2nd test)
timeFrame: 2nd test: after 2-month intervention
measure: Cognitive Tests: for executive function (3rd test)
timeFrame: 3rd test: after 4-month intervention
measure: Cognitive Tests: for executive function (4th test)
timeFrame: 4th test: after 2-month follow up
measure: Cognitive Tests: for attention (pre-test)
timeFrame: Pre-test (1st test): before intervention
measure: Cognitive Tests: for attention (2nd test)
timeFrame: 2nd test: after 2-month intervention
measure: Cognitive Tests: for attention (3rd test)
timeFrame: 3rd test: after 4-month intervention
measure: Cognitive Tests: for attention (4th test)
timeFrame: 4th test: after 2-month follow up
measure: Cognitive Tests: for everyday memory (pre-test)
timeFrame: Pre-test (1st test): before intervention
measure: Cognitive Tests: for everyday memory (2nd test)
timeFrame: 2nd test: after 2-month intervention
measure: Cognitive Tests: for everyday memory (3rd test)
timeFrame: 3rd test: after 4-month intervention
measure: Cognitive Tests: for everyday memory (4th test)
timeFrame: 4th test: after 2-month follow up
Secondary outcomes:
measure: Fitness Tests: BMI (pre-test)
timeFrame: Pre-test (1st test): before intervention
measure: Fitness Tests: BMI (2nd test)
timeFrame: 2nd test: after 2-month intervention
measure: Fitness Tests: BMI (3rd test)
timeFrame: 3rd test: after 4-month intervention
measure: Fitness Tests: BMI (4th test)
timeFrame: 4th test: after 2-month follow up
measure: Fitness Tests: Senior physical fitness test battery (pre-test)
timeFrame: Pre-test (1st test): before intervention
measure: Fitness Tests: Senior physical fitness test battery (2nd test)
timeFrame: 2nd test: after 2-month intervention
measure: Fitness Tests: Senior physical fitness test battery (3rd test)
timeFrame: 3rd test: after 4-month intervention
measure: Fitness Tests: Senior physical fitness test battery (4th test)
timeFrame: 4th test: after 2-month follow up
measure: Four square step test for dynamic balance (pre-test)
timeFrame: Pre-test (1st test): before intervention
measure: Four square step test for dynamic balance (2nd test)
timeFrame: 2nd test: after 2-month intervention
measure: Four square step test for dynamic balance (3rd test)
timeFrame: 3rd test: after 4-month intervention
measure: Four square step test for dynamic balance (4th test)
timeFrame: 4th test: after 2-month follow up
Other outcomes:
measure: Behavioral and motivation survey (pre-test)
timeFrame: Pre-test (1st test): before intervention
measure: Behavioral and motivation survey (2nd test)
timeFrame: 2nd test: after 2-month intervention
measure: Behavioral and motivation survey (3rd test)
timeFrame: 3rd test: after 4-month intervention
measure: Behavioral and Motivation Survey (4th test)
timeFrame: 4th test: after 2-month follow up
measure: Depression and Loneliness Survey (pre-test)
timeFrame: Pre-test (1st test): before intervention
measure: Depression and Loneliness Survey (2nd test)
timeFrame: 2nd test: after 2-month intervention
measure: Depression and Loneliness Survey (3rd test)
timeFrame: 3rd test: after 4-month intervention
measure: Depression and Loneliness Survey (4th test)
timeFrame: 4th test: after 2-month follow up
measure: Physical activity participation Survey (pre-test)
timeFrame: Pre-test (1st test): before intervention
measure: Physical activity participation Survey (2nd test)
timeFrame: 2nd test: after 2-month intervention
measure: Physical activity participation Survey (3rd test)
timeFrame: 3rd test: after 4-month intervention
measure: Physical activity participation Survey (4th test)
timeFrame: 4th test: after 2-month follow up
Locations:
city: Hong Kong
country: Hong Kong
facility: Hong Kong Baptist University
Study officials:
affiliation: Hong Kong Baptist University
name: Bik-Chu CHOW, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fu F, Chow BC. Brain Invigoration and Gross Motor Activation Programme (BIGMAP). Hong Kong Baptist University, Hong Kong. 2019. ISBN: 9789881542137
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.