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

Cognitive Decline Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04727450
• Other study ID #: 12607620
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: March 31, 2023

Study information

• Verified date: January 2021
• Source: Hong Kong Baptist University
• Contact: Bik-Chu CHOW, PhD
• Phone: +85234117007
• Email: bchow[@]hkbu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 228
• Est. completion date: March 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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 ).

Related Conditions & MeSH terms

• Cognitive Decline
• Cognitive Dysfunction
• Cognitive Impairment, Mild

Intervention

Behavioral:
• Cognitive training
Involves participants engaging in selected games which require thinking skills to be played in a group of 2-4 people.
• physical training
Involves learning of preselected routines of "line dancing" taught by a line dance instructor.
• 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).

Locations

Country	Name	City	State
Hong Kong	Hong Kong Baptist University	Hong Kong

Sponsors (3)

Lead Sponsor	Collaborator
Hong Kong Baptist University	Jacobs University Bremen gGmbH, The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Behavioral and motivation survey (pre-test)	Survey on motivation and subjective health status rating	Pre-test (1st test): before intervention
Other	Behavioral and motivation survey (2nd test)	Survey on motivation and subjective health status rating	2nd test: after 2-month intervention
Other	Behavioral and motivation survey (3rd test)	Survey on motivation and subjective health status rating	3rd test: after 4-month intervention
Other	Behavioral and Motivation Survey (4th test)	Survey on motivation and subjective health status rating	4th test: after 2-month follow up
Other	Depression and Loneliness Survey (pre-test)	The Center for Epidemiological Studies-Depression scale (CES-D) and Loneliness	Pre-test (1st test): before intervention
Other	Depression and Loneliness Survey (2nd test)	The Center for Epidemiological Studies-Depression scale (CES-D) and Loneliness	2nd test: after 2-month intervention
Other	Depression and Loneliness Survey (3rd test)	The Center for Epidemiological Studies-Depression scale (CES-D) and Loneliness	3rd test: after 4-month intervention
Other	Depression and Loneliness Survey (4th test)	The Center for Epidemiological Studies-Depression scale (CES-D) and Loneliness	4th test: after 2-month follow up
Other	Physical activity participation Survey (pre-test)	Physical activity participation (TTM)	Pre-test (1st test): before intervention
Other	Physical activity participation Survey (2nd test)	Physical activity participation (TTM)	2nd test: after 2-month intervention
Other	Physical activity participation Survey (3rd test)	Physical activity participation (TTM)	3rd test: after 4-month intervention
Other	Physical activity participation Survey (4th test)	Physical activity participation (TTM)	4th test: after 2-month follow up
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Fitness Tests: Senior physical fitness test battery (pre-test)	Senior physical fitness test	Pre-test (1st test): before intervention
Secondary	Fitness Tests: Senior physical fitness test battery (2nd test)	Senior physical fitness test	2nd test: after 2-month intervention
Secondary	Fitness Tests: Senior physical fitness test battery (3rd test)	Senior physical fitness test	3rd test: after 4-month intervention
Secondary	Fitness Tests: Senior physical fitness test battery (4th test)	Senior physical fitness test	4th test: after 2-month follow up
Secondary	Four square step test for dynamic balance (pre-test)	Four square step test	Pre-test (1st test): before intervention
Secondary	Four square step test for dynamic balance (2nd test)	Four square step test	2nd test: after 2-month intervention
Secondary	Four square step test for dynamic balance (3rd test)	Four square step test	3rd test: after 4-month intervention
Secondary	Four square step test for dynamic balance (4th test)	Four square step test	4th test: after 2-month follow up