Preventing Cognitive Decline

October 3, 2024 updated by: Arizona State University

Modulation Effects of a Novel Body-mind Intervention on Subjective Cognitive Decline

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • 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 Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85004
        • Arizona State University

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

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

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: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: IBMT mindfulness
IBMT is an effortless mindfulness technique; health education is a class including health-related topics - exercise, sleep, nutrition, lifestyle, stress management
Active Comparator: health education
Health education includes health-related topics - exercise, sleep, stress management, nutrition, lifestyle
Behavioral: health education
Health education includes health-related topics - exercise, sleep, stress management, nutrition, lifestyle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Trials Correct On Working Memory Test
Time Frame: The outcome measures are assessed online or/and in-person at baseline and post-intervention (2 weeks).
The percentage of trials correct on N-back working memory test; higher percentage of trials correct mean a better outcome.
The outcome measures are assessed online or/and in-person at baseline and post-intervention (2 weeks).
Intervention Effects on Cognitive Decline
Time Frame: The outcome measures are assessed online or/and in-person at baseline and post-intervention (2 weeks).
The composite measures of cognition such as subjective cognitive decline; the minimum and maximum values (1 and 27); higher scores mean a worse outcome.
The outcome measures are assessed online or/and in-person at baseline and post-intervention (2 weeks).
Intervention Effects on Emotion Regulation
Time Frame: The outcome measures are assessed online or/and in-person at baseline and post-intervention (2 weeks).
The composite measures of executive function such as emotion regulation questionnaire; the minimum and maximum values (4 and 10); higher scores mean a better outcome.
The outcome measures are assessed online or/and in-person at baseline and post-intervention (2 weeks).
Intervention Effects on Mindfulness
Time Frame: The outcome measures are assessed online or/and in-person at baseline and post-intervention (2 weeks).
The composite measures of executive function such as Five Facet Mindfulness Questionnaire; the minimum and maximum values (1 and 5); higher scores mean a better outcome.
The outcome measures are assessed online or/and in-person at baseline and post-intervention (2 weeks).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intervention Effects on Brain Function
Time Frame: The outcome measures are assessed in-person at baseline and post-intervention (2 weeks).
Changes in the strength of brain functional connectivity were measured by functional resting-state brain imaging. Higher numerical values represent stronger connectivity/better outcomes and lower values represent weaker connectivity/worse outcomes. Arbitrary units are used and the theoretical range of the values is from 0 to 1.
The outcome measures are assessed in-person at baseline and post-intervention (2 weeks).
Intervention Effects on Brain White Matter
Time Frame: The outcome measures are assessed in-person at baseline and post-intervention (2 weeks).
Changes in AD-signature cortical brain white matter (i.e., level of fractional anisotropy) were measured by diffusion imaging. Higher numerical values represent higher white matter integrity/better outcomes and lower values represent lower white matter integrity/worse outcomes. Arbitrary units are used and the theoretical range of the values is from 0 to 1.
The outcome measures are assessed in-person at baseline and post-intervention (2 weeks).
Intervention Effects on Brain Grey Matter
Time Frame: The outcome measures are assessed in-person at baseline and post-intervention (2 weeks).
Changes in AD-signature cortical grey matter volume were measured by MRI structural imaging. Higher numerical values represent greater grey matter volume/better outcomes and lower values represent lower grey matter volume/worse outcomes.
The outcome measures are assessed in-person at baseline and post-intervention (2 weeks).

Collaborators and Investigators

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

Sponsor

Arizona State University

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: YiYuan Tang, Arizona State University

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 (Actual)

February 1, 2021

Primary Completion (Actual)

February 28, 2023

Study Completion (Actual)

February 28, 2023

Study Registration Dates

First Submitted

May 25, 2022

First Submitted That Met QC Criteria

July 5, 2022

First Posted (Actual)

July 7, 2022

Study Record Updates

Last Update Posted (Actual)

October 29, 2024

Last Update Submitted That Met QC Criteria

October 3, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022 IBMT SCD
  • 3R61AT010138-03S1 (U.S. NIH Grant/Contract)

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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