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

NCT04727450 | Unknown

• 1 other identifier: 12607620
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Decline; Cognitive Impairment, Mild

Keywords

Intervention programs; Older adults; Cognitive & Physical Training; Cluster RCT; Multimodal

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (12)

• Fitness Tests: BMI (pre-test)

  Pre-test (1st test): before intervention

• Fitness Tests: BMI (2nd test)

  2nd test: after 2-month intervention

• Fitness Tests: BMI (3rd test)

  3rd test: after 4-month intervention

• Fitness Tests: BMI (4th test)

  4th test: after 2-month follow up

• Fitness Tests: Senior physical fitness test battery (pre-test)

  Pre-test (1st test): before intervention

Other Outcomes (12)

• Behavioral and motivation survey (pre-test)

  Pre-test (1st test): before intervention

• Behavioral and motivation survey (2nd test)

  2nd test: after 2-month intervention

• Behavioral and motivation survey (3rd test)

  3rd test: after 4-month intervention

Study Arms (5)

1. Integrated format

ACTIVE COMPARATOR

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

Behavioral: Cognitive training; Behavioral: physical training; Behavioral: Combination of cognitive and physical training (CCPT)-BIGMAP

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

ACTIVE COMPARATOR

Intervention of A \& B treatments.

Behavioral: Cognitive training; Behavioral: physical training

3. Physical training + CCPT (B+C)

ACTIVE COMPARATOR

Intervention of B \& C treatments.

Behavioral: physical training; Behavioral: Combination of cognitive and physical training (CCPT)-BIGMAP

4. CCPT + Cognitive training (C+A)

ACTIVE COMPARATOR

Intervention of C \& A treatments.

Behavioral: Cognitive training; Behavioral: Combination of cognitive and physical training (CCPT)-BIGMAP

5. Control group

NO INTERVENTION

No intervention

Interventions

Cognitive training BEHAVIORAL

Involves participants engaging in selected games which require thinking skills to be played in a group of 2-4 people.

1. Integrated format; 2. Cognitive training + Physical Training (A+B); 4. CCPT + Cognitive training (C+A)

physical training BEHAVIORAL

Involves learning of preselected routines of "line dancing" taught by a line dance instructor.

1. Integrated format; 2. Cognitive training + Physical Training (A+B); 3. Physical training + CCPT (B+C)

Combination of cognitive and physical training (CCPT)-BIGMAP BEHAVIORAL

BIGMAP is a program engaging participants in specially designed cognitive/memory games together with physical training (Fu \& Chow, 2019).

Also known as: "Brain Invigoration Gross Motor Activation Program" (BIGMAP)

1. Integrated format; 3. Physical training + CCPT (B+C); 4. CCPT + Cognitive training (C+A)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 ).

Sponsors & Collaborators

• Hong Kong Baptist University: lead
• Jacobs University Bremen gGmbH: collaborator
• The Hong Kong Polytechnic University: collaborator

Study Sites (1)

Hong Kong Baptist University

Hong Kong, 00852, Hong Kong

Location

Related Publications (2)

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

  BACKGROUND

• 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.

  PMID: 35524188 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Cognitive Training; Physical Conditioning, Human

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Bik-Chu CHOW, PhD

  Hong Kong Baptist University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bik-Chu CHOW, PhD

CONTACT

+85234117007; bchow@hkbu.edu.hk

Jojo JIAO, PhD

CONTACT

+85234115758; jojojiao@hkbu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: No information will be given to test administrators about intervention or control groups with the exception of project staff.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 17, 2021
• First Posted: January 27, 2021
• Study Start: April 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: March 31, 2023
• Last Updated: January 27, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)