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

Primary Purpose

Cognitive Decline, Cognitive Impairment, Mild

Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Cognitive training
physical training
Combination of cognitive and physical training (CCPT)-BIGMAP
Sponsored by
Hong Kong Baptist University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cognitive Decline focused on measuring Intervention programs, Older adults, Cognitive & Physical Training, Cluster RCT, Multimodal

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 ).

Sites / Locations

  • Hong Kong Baptist University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

No Intervention

Arm Label

1. Integrated format

2. Cognitive training + Physical Training (A+B)

3. Physical training + CCPT (B+C)

4. CCPT + Cognitive training (C+A)

5. Control group

Arm Description

Integrated or Combination of ABC of A: cognitive training. B: physical training and C: Combined Cognitive and Physical Training (CCPT).

Intervention of A & B treatments.

Intervention of B & C treatments.

Intervention of C & A treatments.

No intervention

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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
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
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
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
Fitness Tests: Senior physical fitness test battery (pre-test)
Senior physical fitness test
Fitness Tests: Senior physical fitness test battery (2nd test)
Senior physical fitness test
Fitness Tests: Senior physical fitness test battery (3rd test)
Senior physical fitness test
Fitness Tests: Senior physical fitness test battery (4th test)
Senior physical fitness test
Four square step test for dynamic balance (pre-test)
Four square step test
Four square step test for dynamic balance (2nd test)
Four square step test
Four square step test for dynamic balance (3rd test)
Four square step test
Four square step test for dynamic balance (4th test)
Four square step test

Full Information

First Posted
January 17, 2021
Last Updated
January 22, 2021
Sponsor
Hong Kong Baptist University
Collaborators
Jacobs University Bremen gGmbH, The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT04727450
Brief Title
Effects of Multimodal Training of Combined Cognitive and/or Physical Training on Cognition and Fitness of Older Adults
Acronym
MTCCP
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

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2021 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hong Kong Baptist University
Collaborators
Jacobs University Bremen gGmbH, The Hong Kong Polytechnic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Decline, Cognitive Impairment, Mild
Keywords
Intervention programs, Older adults, Cognitive & Physical Training, Cluster RCT, Multimodal

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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.
Masking
Outcomes Assessor
Masking Description
No information will be given to test administrators about intervention or control groups with the exception of project staff.
Allocation
Randomized
Enrollment
228 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1. Integrated format
Arm Type
Active Comparator
Arm Description
Integrated or Combination of ABC of A: cognitive training. B: physical training and C: Combined Cognitive and Physical Training (CCPT).
Arm Title
2. Cognitive training + Physical Training (A+B)
Arm Type
Active Comparator
Arm Description
Intervention of A & B treatments.
Arm Title
3. Physical training + CCPT (B+C)
Arm Type
Active Comparator
Arm Description
Intervention of B & C treatments.
Arm Title
4. CCPT + Cognitive training (C+A)
Arm Type
Active Comparator
Arm Description
Intervention of C & A treatments.
Arm Title
5. Control group
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Behavioral
Intervention Name(s)
Cognitive training
Intervention Description
Involves participants engaging in selected games which require thinking skills to be played in a group of 2-4 people.
Intervention Type
Behavioral
Intervention Name(s)
physical training
Intervention Description
Involves learning of preselected routines of "line dancing" taught by a line dance instructor.
Intervention Type
Behavioral
Intervention Name(s)
Combination of cognitive and physical training (CCPT)-BIGMAP
Other Intervention Name(s)
"Brain Invigoration Gross Motor Activation Program" (BIGMAP)
Intervention Description
BIGMAP is a program engaging participants in specially designed cognitive/memory games together with physical training (Fu & Chow, 2019).
Primary Outcome Measure Information:
Title
Cognitive Tests: for executive function (pre-test)
Description
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.
Time Frame
Pre-test (1st test): before intervention
Title
Cognitive Tests: for executive function (2nd test)
Description
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.
Time Frame
2nd test: after 2-month intervention
Title
Cognitive Tests: for executive function (3rd test)
Description
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.
Time Frame
3rd test: after 4-month intervention
Title
Cognitive Tests: for executive function (4th test)
Description
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.
Time Frame
4th test: after 2-month follow up
Title
Cognitive Tests: for attention (pre-test)
Description
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.
Time Frame
Pre-test (1st test): before intervention
Title
Cognitive Tests: for attention (2nd test)
Description
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.
Time Frame
2nd test: after 2-month intervention
Title
Cognitive Tests: for attention (3rd test)
Description
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.
Time Frame
3rd test: after 4-month intervention
Title
Cognitive Tests: for attention (4th test)
Description
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.
Time Frame
4th test: after 2-month follow up
Title
Cognitive Tests: for everyday memory (pre-test)
Description
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.
Time Frame
Pre-test (1st test): before intervention
Title
Cognitive Tests: for everyday memory (2nd test)
Description
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.
Time Frame
2nd test: after 2-month intervention
Title
Cognitive Tests: for everyday memory (3rd test)
Description
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.
Time Frame
3rd test: after 4-month intervention
Title
Cognitive Tests: for everyday memory (4th test)
Description
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.
Time Frame
4th test: after 2-month follow up
Secondary Outcome Measure Information:
Title
Fitness Tests: BMI (pre-test)
Description
Weight and height will be tested and combined to report BMI in kg/m^2 in four evaluation time frames
Time Frame
Pre-test (1st test): before intervention
Title
Fitness Tests: BMI (2nd test)
Description
Weight and height will be tested and combined to report BMI in kg/m^2 in four evaluation time frames
Time Frame
2nd test: after 2-month intervention
Title
Fitness Tests: BMI (3rd test)
Description
Weight and height will be tested and combined to report BMI in kg/m^2 in four evaluation time frames
Time Frame
3rd test: after 4-month intervention
Title
Fitness Tests: BMI (4th test)
Description
Weight and height will be tested and combined to report BMI in kg/m^2 in four evaluation time frames
Time Frame
4th test: after 2-month follow up
Title
Fitness Tests: Senior physical fitness test battery (pre-test)
Description
Senior physical fitness test
Time Frame
Pre-test (1st test): before intervention
Title
Fitness Tests: Senior physical fitness test battery (2nd test)
Description
Senior physical fitness test
Time Frame
2nd test: after 2-month intervention
Title
Fitness Tests: Senior physical fitness test battery (3rd test)
Description
Senior physical fitness test
Time Frame
3rd test: after 4-month intervention
Title
Fitness Tests: Senior physical fitness test battery (4th test)
Description
Senior physical fitness test
Time Frame
4th test: after 2-month follow up
Title
Four square step test for dynamic balance (pre-test)
Description
Four square step test
Time Frame
Pre-test (1st test): before intervention
Title
Four square step test for dynamic balance (2nd test)
Description
Four square step test
Time Frame
2nd test: after 2-month intervention
Title
Four square step test for dynamic balance (3rd test)
Description
Four square step test
Time Frame
3rd test: after 4-month intervention
Title
Four square step test for dynamic balance (4th test)
Description
Four square step test
Time Frame
4th test: after 2-month follow up
Other Pre-specified Outcome Measures:
Title
Behavioral and motivation survey (pre-test)
Description
Survey on motivation and subjective health status rating
Time Frame
Pre-test (1st test): before intervention
Title
Behavioral and motivation survey (2nd test)
Description
Survey on motivation and subjective health status rating
Time Frame
2nd test: after 2-month intervention
Title
Behavioral and motivation survey (3rd test)
Description
Survey on motivation and subjective health status rating
Time Frame
3rd test: after 4-month intervention
Title
Behavioral and Motivation Survey (4th test)
Description
Survey on motivation and subjective health status rating
Time Frame
4th test: after 2-month follow up
Title
Depression and Loneliness Survey (pre-test)
Description
The Center for Epidemiological Studies-Depression scale (CES-D) and Loneliness
Time Frame
Pre-test (1st test): before intervention
Title
Depression and Loneliness Survey (2nd test)
Description
The Center for Epidemiological Studies-Depression scale (CES-D) and Loneliness
Time Frame
2nd test: after 2-month intervention
Title
Depression and Loneliness Survey (3rd test)
Description
The Center for Epidemiological Studies-Depression scale (CES-D) and Loneliness
Time Frame
3rd test: after 4-month intervention
Title
Depression and Loneliness Survey (4th test)
Description
The Center for Epidemiological Studies-Depression scale (CES-D) and Loneliness
Time Frame
4th test: after 2-month follow up
Title
Physical activity participation Survey (pre-test)
Description
Physical activity participation (TTM)
Time Frame
Pre-test (1st test): before intervention
Title
Physical activity participation Survey (2nd test)
Description
Physical activity participation (TTM)
Time Frame
2nd test: after 2-month intervention
Title
Physical activity participation Survey (3rd test)
Description
Physical activity participation (TTM)
Time Frame
3rd test: after 4-month intervention
Title
Physical activity participation Survey (4th test)
Description
Physical activity participation (TTM)
Time Frame
4th test: after 2-month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 ).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bik-Chu CHOW, PhD
Phone
+85234117007
Email
bchow@hkbu.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Jojo JIAO, PhD
Phone
+85234115758
Email
jojojiao@hkbu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bik-Chu CHOW, PhD
Organizational Affiliation
Hong Kong Baptist University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hong Kong Baptist University
City
Hong Kong
ZIP/Postal Code
00852
Country
Hong Kong
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bik-Chu CHOW, PhD
Phone
+85234117007
Email
bchow@hkbu.edu.hk
First Name & Middle Initial & Last Name & Degree
Jojo JIAO, PhD
Phone
+85234115758
Email
jojojiao@hkbu.edu.hk
First Name & Middle Initial & Last Name & Degree
Bik-Chu CHOW, PhD
First Name & Middle Initial & Last Name & Degree
Sonia LIPPKE, PhD
First Name & Middle Initial & Last Name & Degree
Wai-Kwong MAN, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
In our application of university human ethics, we have declared non-disclosure of individual data.
Citations:
Citation
Fu F, Chow BC. Brain Invigoration and Gross Motor Activation Programme (BIGMAP). Hong Kong Baptist University, Hong Kong. 2019. ISBN: 9789881542137
Results Reference
background
PubMed Identifier
35524188
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.
Results Reference
derived

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

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