Project Gnosis: the Neurophysical and Psychosocial Health Outcomes of Tai Chi for Older Adults with Cognitive Concerns or Mild Cognitive Impairment

NCT06828926 | Recruiting DMC

• 1 other identifier: Ohio_U_FY25-124
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Mild Cognitive Impairment (MCI) in older adults is linked to muscle loss (sarcopenia) and can lead to dementia, with pain further impacting cognitive and physical performance. Tai Chi, a mind-body exercise, is recommended for managing MCI as it supports cognitive function, mood, and physical health. The investigators' first goal is to characterize the correlation of heart rate variability and cortical activity on cognitive function and the psychosocial correlates of pain interference and social isolation on cognitive function at baseline and post-intervention (8 weeks of Tai Chi). The second goal is to explain the role of sarcopenia and obesity in the relationship between pain interference and cognitive function. The investigators also want to examine the index of the predictive capacity regarding sarcopenia and obesity on cognitive function outcomes.

Conditions

Mild Cognitive Impairment (MCI); Sarcopenia

Keywords

Tai Chi; Cognitive Function

Outcome Measures

Primary Outcomes (2)

• Executive Function - Stroop Color-Word Interference Test

  Delis-Kaplan Executive Function System Stroop Color-Word Interference Test

  From enrollment to the end of treatment at 8 weeks

• Executive Function - Semantic Fluency Test

  Repeatable Battery for the Assessment of Neuropsychological Status - Semantic Fluency Test

  From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (7)

• Cognitive Function - Processing Speed

  From enrollment to the end of treatment at 8 weeks

• Pain Interference

  From enrollment to the end of treatment at 8 weeks

• Social Isolation

  From enrollment to the end of treatment at 8 weeks

• Positive Affect

  From enrollment to the end of treatment at 8 weeks

• Meaning and Purpose

  From enrollment to the end of treatment at 8 weeks

Other Outcomes (8)

• Cognitive Assessment Screen

  From enrollment only

• Body Mass Index

  From enrollment only

• Physical Performance Test Battery for Sarcopenia (1 of 6)

  From enrollment to the end of treatment at 8 weeks

Study Arms (1)

Tai Chi

EXPERIMENTAL

The Tai Chi program content is based on the Harvard Medical School (HMS) Guide to Tai Chi, developed by clinical scientist Dr. Peter M. Wayne. Each participant will receive a workbook that describes the philosophy, evidence, and practice of Tai Chi, along with a video series for home practice that features the exercises from the HMS Guide to Tai Chi program. The in-person classes will be led by the Principal Investigator (PI) and delivered weekly over 8 weeks, with 75-minute sessions. The in-person and video series will introduce practice principles and tips on establishing and maintaining a practice, followed by a series of warm-up exercises, Tai Chi movements, and cool-down exercises.

Behavioral: Tai Chi

Interventions

Tai Chi BEHAVIORAL

The Tai Chi program content is based on the Harvard Medical School (HMS) Guide to Tai Chi, developed by clinical scientist Dr. Peter M. Wayne. Each participant will receive a workbook that describes the philosophy, evidence, and practice of Tai Chi, along with a video series for home practice that features the exercises from the HMS Guide to Tai Chi program. The in-person classes will be led by the PI and delivered weekly over 8 weeks, with 75-minute sessions. The in-person and video series will include an introduction to the principles of practice and tips on establishing and maintaining a practice, followed by a series of warm-up exercises, Tai Chi movements, and cool-down exercises. The Tin-person (and offer virtual live sessions for those who cannot attend in-person) over 8 weeks, accompanied by a workbook and video-recorded practices to promote self-management.

Tai Chi

Eligibility Criteria

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

You may qualify if:

• Participants who are older adults, defined as ≥60 years old.
• Participants must have the ability to independently stand without the use of an assistive device for 20 minutes.
• People with Mild Cognitive Impairment (MCI) (initial cohort) and without MCI (age-gender matched healthy controls). A score of between \>18 and ≤26 on the Montreal Cognitive Assessment (MoCA) will be used to classify MCI. A score above 26 is considered normal.

You may not qualify if:

• Participants with significant uncontrolled medication, and cardiovascular, respiratory, and metabolic symptoms will be excluded from participation in the study, as these symptoms could impact their engagement with the engagement of Tai Chi.
• Investigators will administer a brief screening questionnaire to assess (a) hypotension symptoms related to intensive treatment of hypertension and (b) hypoglycemia related to intensive treatment of diabetes, as these conditions are associated with cognitive decline.
• Investigators will capture data on potential sleep apnea and administer the Stop-Bang Questionnaire to identify potential sleep-disordered breathing. Participants with significant uncontrolled sleep apnea will be excluded as this could also impact their engagement in the intervention and influence the primary outcome measure of cognitive function.
• \. Currently or recently practicing Tai Chi. Participants will be excluded if they are currently practicing Tai Chi. If participants have previously engaged in Tai Chi, there will be a washout period of at least 6 months before considering enrollment in the study.

Sponsors & Collaborators

• Ohio University: lead

Study Sites (1)

Ohio University

Athens, Ohio, 45701, United States

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Sarcopenia

Interventions

Tai Ji

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Central Study Contacts

Nicholas Karayannis, MPT, PhD

CONTACT

+1 740-593-1044; nvkaray@ohio.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: February 17, 2025
• Study Start: February 12, 2025
• Primary Completion: February 1, 2026
• Study Completion: March 1, 2026
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Immediately following publication. No end date.

Locations

US (1)