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

NCT ID: NCT04727450

Last Updated: 2021-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

228 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2023-03-31

Brief Summary

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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

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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.

Conditions

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Cognitive Decline Cognitive Impairment, Mild

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
No information will be given to test administrators about intervention or control groups with the exception of project staff.

Study Groups

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1. Integrated format

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

Group Type ACTIVE_COMPARATOR

Cognitive training

Intervention Type BEHAVIORAL

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

physical training

Intervention Type BEHAVIORAL

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

Combination of cognitive and physical training (CCPT)-BIGMAP

Intervention Type BEHAVIORAL

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

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

Intervention of A \& B treatments.

Group Type ACTIVE_COMPARATOR

Cognitive training

Intervention Type BEHAVIORAL

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

physical training

Intervention Type BEHAVIORAL

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

3. Physical training + CCPT (B+C)

Intervention of B \& C treatments.

Group Type ACTIVE_COMPARATOR

physical training

Intervention Type BEHAVIORAL

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

Combination of cognitive and physical training (CCPT)-BIGMAP

Intervention Type BEHAVIORAL

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

4. CCPT + Cognitive training (C+A)

Intervention of C \& A treatments.

Group Type ACTIVE_COMPARATOR

Cognitive training

Intervention Type BEHAVIORAL

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

Combination of cognitive and physical training (CCPT)-BIGMAP

Intervention Type BEHAVIORAL

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

5. Control group

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cognitive training

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

Intervention Type BEHAVIORAL

physical training

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

Intervention Type 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).

Intervention Type BEHAVIORAL

Other Intervention Names

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"Brain Invigoration Gross Motor Activation Program" (BIGMAP)

Eligibility Criteria

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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 ).
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jacobs University Bremen gGmbH

OTHER

Sponsor Role collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role collaborator

Hong Kong Baptist University

OTHER

Sponsor Role lead

Responsible Party

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Chow Bik-chu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bik-Chu CHOW, PhD

Role: PRINCIPAL_INVESTIGATOR

Hong Kong Baptist University

Locations

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Hong Kong Baptist University

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

Central Contacts

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Bik-Chu CHOW, PhD

Role: CONTACT

+85234117007

Jojo JIAO, PhD

Role: CONTACT

+85234115758

Facility Contacts

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Bik-Chu CHOW, PhD

Role: primary

+85234117007

Jojo JIAO, PhD

Role: backup

+85234115758

References

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

Reference Type 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.

Reference Type DERIVED
PMID: 35524188 (View on PubMed)

Other Identifiers

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12607620

Identifier Type: -

Identifier Source: org_study_id

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