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

January 22, 2021 updated by: Chow Bik-chu, Hong Kong Baptist University

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
228

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong, 00852
        • Hong Kong Baptist University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Bik-Chu CHOW, PhD
        • Sub-Investigator:
          • Sonia LIPPKE, PhD
        • Sub-Investigator:
          • Wai-Kwong MAN, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cognitive Tests: for executive function (pre-test)
Time Frame: 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.
Pre-test (1st test): before intervention
Cognitive Tests: for executive function (2nd test)
Time Frame: 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.
2nd test: after 2-month intervention
Cognitive Tests: for executive function (3rd test)
Time Frame: 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.
3rd test: after 4-month intervention
Cognitive Tests: for executive function (4th test)
Time Frame: 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.
4th test: after 2-month follow up
Cognitive Tests: for attention (pre-test)
Time Frame: 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.
Pre-test (1st test): before intervention
Cognitive Tests: for attention (2nd test)
Time Frame: 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.
2nd test: after 2-month intervention
Cognitive Tests: for attention (3rd test)
Time Frame: 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.
3rd test: after 4-month intervention
Cognitive Tests: for attention (4th test)
Time Frame: 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.
4th test: after 2-month follow up
Cognitive Tests: for everyday memory (pre-test)
Time Frame: 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.
Pre-test (1st test): before intervention
Cognitive Tests: for everyday memory (2nd test)
Time Frame: 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.
2nd test: after 2-month intervention
Cognitive Tests: for everyday memory (3rd test)
Time Frame: 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.
3rd test: after 4-month intervention
Cognitive Tests: for everyday memory (4th test)
Time Frame: 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.
4th test: after 2-month follow up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fitness Tests: BMI (pre-test)
Time Frame: 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
Pre-test (1st test): before intervention
Fitness Tests: BMI (2nd test)
Time Frame: 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
2nd test: after 2-month intervention
Fitness Tests: BMI (3rd test)
Time Frame: 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
3rd test: after 4-month intervention
Fitness Tests: BMI (4th test)
Time Frame: 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
4th test: after 2-month follow up
Fitness Tests: Senior physical fitness test battery (pre-test)
Time Frame: Pre-test (1st test): before intervention
Senior physical fitness test
Pre-test (1st test): before intervention
Fitness Tests: Senior physical fitness test battery (2nd test)
Time Frame: 2nd test: after 2-month intervention
Senior physical fitness test
2nd test: after 2-month intervention
Fitness Tests: Senior physical fitness test battery (3rd test)
Time Frame: 3rd test: after 4-month intervention
Senior physical fitness test
3rd test: after 4-month intervention
Fitness Tests: Senior physical fitness test battery (4th test)
Time Frame: 4th test: after 2-month follow up
Senior physical fitness test
4th test: after 2-month follow up
Four square step test for dynamic balance (pre-test)
Time Frame: Pre-test (1st test): before intervention
Four square step test
Pre-test (1st test): before intervention
Four square step test for dynamic balance (2nd test)
Time Frame: 2nd test: after 2-month intervention
Four square step test
2nd test: after 2-month intervention
Four square step test for dynamic balance (3rd test)
Time Frame: 3rd test: after 4-month intervention
Four square step test
3rd test: after 4-month intervention
Four square step test for dynamic balance (4th test)
Time Frame: 4th test: after 2-month follow up
Four square step test
4th test: after 2-month follow up

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Behavioral and motivation survey (pre-test)
Time Frame: Pre-test (1st test): before intervention
Survey on motivation and subjective health status rating
Pre-test (1st test): before intervention
Behavioral and motivation survey (2nd test)
Time Frame: 2nd test: after 2-month intervention
Survey on motivation and subjective health status rating
2nd test: after 2-month intervention
Behavioral and motivation survey (3rd test)
Time Frame: 3rd test: after 4-month intervention
Survey on motivation and subjective health status rating
3rd test: after 4-month intervention
Behavioral and Motivation Survey (4th test)
Time Frame: 4th test: after 2-month follow up
Survey on motivation and subjective health status rating
4th test: after 2-month follow up
Depression and Loneliness Survey (pre-test)
Time Frame: Pre-test (1st test): before intervention
The Center for Epidemiological Studies-Depression scale (CES-D) and Loneliness
Pre-test (1st test): before intervention
Depression and Loneliness Survey (2nd test)
Time Frame: 2nd test: after 2-month intervention
The Center for Epidemiological Studies-Depression scale (CES-D) and Loneliness
2nd test: after 2-month intervention
Depression and Loneliness Survey (3rd test)
Time Frame: 3rd test: after 4-month intervention
The Center for Epidemiological Studies-Depression scale (CES-D) and Loneliness
3rd test: after 4-month intervention
Depression and Loneliness Survey (4th test)
Time Frame: 4th test: after 2-month follow up
The Center for Epidemiological Studies-Depression scale (CES-D) and Loneliness
4th test: after 2-month follow up
Physical activity participation Survey (pre-test)
Time Frame: Pre-test (1st test): before intervention
Physical activity participation (TTM)
Pre-test (1st test): before intervention
Physical activity participation Survey (2nd test)
Time Frame: 2nd test: after 2-month intervention
Physical activity participation (TTM)
2nd test: after 2-month intervention
Physical activity participation Survey (3rd test)
Time Frame: 3rd test: after 4-month intervention
Physical activity participation (TTM)
3rd test: after 4-month intervention
Physical activity participation Survey (4th test)
Time Frame: 4th test: after 2-month follow up
Physical activity participation (TTM)
4th test: after 2-month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hong Kong Baptist University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Hong Kong Polytechnic University
Jacobs University Bremen gGmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bik-Chu CHOW, PhD, Hong Kong Baptist University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 17, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 27, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 27, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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