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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cognitive Decline; Cognitive Impairment, Mild
• Intervention / Treatment: Behavioral: Cognitive training; Behavioral: physical training; Behavioral: Combination of cognitive and physical training (CCPT)-BIGMAP

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 Type: Interventional
• Enrollment (Anticipated): 228
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bik-Chu CHOW, PhD; Phone Number: +85234117007; Email: bchow@hkbu.edu.hk
• Study Contact Backup: Name: Jojo JIAO, PhD; Phone Number: +85234115758; Email: jojojiao@hkbu.edu

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong, 00852
    • Hong Kong Baptist University
    • Contact: Bik-Chu CHOW, PhD; Phone Number: +85234117007; Email: bchow@hkbu.edu.hk
    • Contact: Jojo JIAO, PhD; Phone Number: +85234115758; Email: jojojiao@hkbu.edu.hk
    • Principal Investigator: Bik-Chu CHOW, PhD
    • Sub-Investigator: Sonia LIPPKE, PhD
    • Sub-Investigator: Wai-Kwong MAN, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 ).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hong Kong Baptist University
• Collaborators: The Hong Kong Polytechnic University; Jacobs University Bremen gGmbH
• Investigators: Principal Investigator: Bik-Chu CHOW, PhD, Hong Kong Baptist University

Publications and helpful links

General Publications

• Fu F, Chow BC. Brain Invigoration and Gross Motor Activation Programme (BIGMAP). Hong Kong Baptist University, Hong Kong. 2019. ISBN: 9789881542137
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): March 31, 2023

Study Registration Dates

• First Submitted: January 17, 2021
• First Submitted That Met QC Criteria: January 22, 2021
• First Posted (Actual): January 27, 2021

Study Record Updates

• Last Update Posted (Actual): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 22, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Older adults; Multimodal; Cluster RCT; Intervention programs; Cognitive & Physical Training
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 12607620

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: In our application of university human ethics, we have declared non-disclosure of individual data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No