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

Sponsor

Hong Kong Baptist University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04727450

Collaborator

Jacobs University Bremen gGmbH (Other), The Hong Kong Polytechnic University (Other)

228

Enrollment

Location

Arms

Anticipated Duration (Months)

9.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cognitive Decline Cognitive Impairment, Mild	Behavioral: Cognitive training Behavioral: physical training Behavioral: Combination of cognitive and physical training (CCPT)-BIGMAP	N/A

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

Anticipated Enrollment :

228 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

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.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 (Outcomes Assessor)

Masking Description:

No information will be given to test administrators about intervention or control groups with the exception of project staff.

Primary Purpose:

Prevention

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

Anticipated Study Start Date :

Apr 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Mar 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Cognitive Tests: for executive function (pre-test) [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.
Cognitive Tests: for executive function (2nd test) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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.

Secondary Outcome Measures

Fitness Tests: BMI (pre-test) [Pre-test (1st test): before intervention]
Weight and height will be tested and combined to report BMI in kg/m^2 in four evaluation time frames
Fitness Tests: BMI (2nd test) [2nd test: after 2-month intervention]
Weight and height will be tested and combined to report BMI in kg/m^2 in four evaluation time frames
Fitness Tests: BMI (3rd test) [3rd test: after 4-month intervention]
Weight and height will be tested and combined to report BMI in kg/m^2 in four evaluation time frames
Fitness Tests: BMI (4th test) [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
Fitness Tests: Senior physical fitness test battery (pre-test) [Pre-test (1st test): before intervention]
Senior physical fitness test
Fitness Tests: Senior physical fitness test battery (2nd test) [2nd test: after 2-month intervention]
Senior physical fitness test
Fitness Tests: Senior physical fitness test battery (3rd test) [3rd test: after 4-month intervention]
Senior physical fitness test
Fitness Tests: Senior physical fitness test battery (4th test) [4th test: after 2-month follow up]
Senior physical fitness test
Four square step test for dynamic balance (pre-test) [Pre-test (1st test): before intervention]
Four square step test
Four square step test for dynamic balance (2nd test) [2nd test: after 2-month intervention]
Four square step test
Four square step test for dynamic balance (3rd test) [3rd test: after 4-month intervention]
Four square step test
Four square step test for dynamic balance (4th test) [4th test: after 2-month follow up]
Four square step test

Other Outcome Measures

Behavioral and motivation survey (pre-test) [Pre-test (1st test): before intervention]
Survey on motivation and subjective health status rating
Behavioral and motivation survey (2nd test) [2nd test: after 2-month intervention]
Survey on motivation and subjective health status rating
Behavioral and motivation survey (3rd test) [3rd test: after 4-month intervention]
Survey on motivation and subjective health status rating
Behavioral and Motivation Survey (4th test) [4th test: after 2-month follow up]
Survey on motivation and subjective health status rating
Depression and Loneliness Survey (pre-test) [Pre-test (1st test): before intervention]
The Center for Epidemiological Studies-Depression scale (CES-D) and Loneliness
Depression and Loneliness Survey (2nd test) [2nd test: after 2-month intervention]
The Center for Epidemiological Studies-Depression scale (CES-D) and Loneliness
Depression and Loneliness Survey (3rd test) [3rd test: after 4-month intervention]
The Center for Epidemiological Studies-Depression scale (CES-D) and Loneliness
Depression and Loneliness Survey (4th test) [4th test: after 2-month follow up]
The Center for Epidemiological Studies-Depression scale (CES-D) and Loneliness
Physical activity participation Survey (pre-test) [Pre-test (1st test): before intervention]
Physical activity participation (TTM)
Physical activity participation Survey (2nd test) [2nd test: after 2-month intervention]
Physical activity participation (TTM)
Physical activity participation Survey (3rd test) [3rd test: after 4-month intervention]
Physical activity participation (TTM)
Physical activity participation Survey (4th test) [4th test: after 2-month follow up]
Physical activity participation (TTM)

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

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 ).