Preventing Cognitive Decline

NCT ID: NCT05446909

Last Updated: 2024-10-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2023-02-28

Brief Summary

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The study aims to understand the mechanisms and training effects of evidence-based body-mind training on improving cognitive performance and preventing cognitive decline.

Detailed Description

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Subjective cognitive decline (SCD), the self-reported perception of memory or cognitive problems, is a risk factor for the cognitive decline and development of Alzheimer's (AD) and often happens in midlife. Recently, few mind-body interventions have suggested promising effects in preventing cognitive decline. However, these interventions often require longer training time (months to years) to achieve modest benefits, making them less optimal for rapidly learning and achieving desirable outcomes. One mechanism for cognitive decline and AD may involve deficits in self-control networks, and autonomic nervous system (ANS) and these deficits can be ameliorated through body-mind interventions. This study aims to investigate the modulation effects of a novel body-mind intervention on SCD using an evidence-based preventive intervention - integrative body-mind training (IBMT).

Conditions

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Cognitive Decline

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

mindfulness vs. health education
Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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IBMT mindfulness

An evidence-based preventive intervention - integrative body-mind training (IBMT) has shown positive effects in reducing stress, and improving self-control and brain plasticity related to cognitive performance. It has bodifulness and mindfulness components.

Group Type EXPERIMENTAL

IBMT mindfulness

Intervention Type BEHAVIORAL

IBMT is an effortless mindfulness technique; health education is a class including health-related topics - exercise, sleep, nutrition, lifestyle, stress management

health education

Health education includes health-related topics - exercise, sleep, stress management, nutrition, lifestyle

Group Type ACTIVE_COMPARATOR

health education

Intervention Type BEHAVIORAL

Health education includes health-related topics - exercise, sleep, stress management, nutrition, lifestyle

Interventions

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IBMT mindfulness

IBMT is an effortless mindfulness technique; health education is a class including health-related topics - exercise, sleep, nutrition, lifestyle, stress management

Intervention Type BEHAVIORAL

health education

Health education includes health-related topics - exercise, sleep, stress management, nutrition, lifestyle

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Able to read/understand English
* Normal performance using standardized cognitive tests
* Self-reported decline in cognitive capacity such as memory loss
* Eligible for non-invasive fMRI
* Willing to be randomized
* Free of any severe psychiatric diagnoses or medication that may affect participation

Exclusion Criteria

* Medical disorders or medications that affect the central and autonomic nervous system; or a positive pregnancy test result (females)
* Unable to provide consent or understand study procedures due to mental illness or cognitive limitations
* Previous meditation experiences
* Evidence of illicit drug use
* Participants for blood draws weigh less than 110 lbs
* Metal or metallic materials in the body such as pacemaker
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

Arizona State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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YiYuan Tang

Role: PRINCIPAL_INVESTIGATOR

Arizona State University

Locations

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Arizona State University

Phoenix, Arizona, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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3R61AT010138-03S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2022 IBMT SCD

Identifier Type: -

Identifier Source: org_study_id

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