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

NCT ID: NCT06828926

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-12
• Study Completion Date: 2026-03-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tai Chi

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.

Group Type: EXPERIMENTAL

Tai Chi

Intervention Type: 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.

Interventions

Tai Chi

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Participants who are older adults, defined as ≥60 years old.

2. Participants must have the ability to independently stand without the use of an assistive device for 20 minutes.

3. 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.

Exclusion Criteria

1. 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.

2. 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.

3. 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.

2. 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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ohio University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ohio University

Athens, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Nicholas Karayannis, MPT, PhD

Role: CONTACT

nvkaray@ohio.edu

+1 740-593-1044

Facility Contacts

Nicholas Karayannis

Role: primary

nvkaray@ohio.edu

740-593-1044

Other Identifiers

Ohio_U_FY25-124

Identifier Type: -

Identifier Source: org_study_id