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

Project Gnosis: the Neural, Physical, and Psychosocial Processes and Health Outcomes of an 8-week Tai Chi Intervention in Older Adults with and Without Mild Cognitive Impairment

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.

Study Overview

• Status: Recruiting
• Conditions: Mild Cognitive Impairment (MCI); Sarcopenia
• Intervention / Treatment: Behavioral: Tai Chi

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicholas Karayannis, MPT, PhD; Phone Number: +1 740-593-1044; Email: nvkaray@ohio.edu

Study Locations

• United States
  • Ohio
    • Athens, Ohio, United States, 45701
      • Recruiting
      • Ohio University
      • Contact: Nicholas Karayannis; Phone Number: 740-593-1044; Email: nvkaray@ohio.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive Function - Processing Speed	Repeatable Battery for the Assessment of Neuropsychological Status Coding Test	From enrollment to the end of treatment at 8 weeks
Pain Interference	Patient Reported Outcome Measurement Information System (PROMIS) - Pain Interference Item Bank	From enrollment to the end of treatment at 8 weeks
Social Isolation	Patient Reported Outcome Measurement Information System (PROMIS) Social Isolation Item Bank	From enrollment to the end of treatment at 8 weeks
Positive Affect	Patient Reported Outcome Measurement Information System (PROMIS) Positive Affect Item Bank	From enrollment to the end of treatment at 8 weeks
Meaning and Purpose	Patient Reported Outcome Measurement Information System (PROMIS) Meaning and Purpose Item bank	From enrollment to the end of treatment at 8 weeks
Heart Rate Variability	Heart Rate Variability recorded while sitting for 5 minutes using a photoplethysmogram.	From enrollment to the end of treatment at 8 weeks
Cortical activity	Cortical activity will be recorded during a brief Tai Chi Practice before and after the 8-week Tai Chi intervention using a functional Near Infrared Spectroscopy system.	From enrollment to the end of treatment at 8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive Assessment Screen	Montreal Cognitive Assessment used as a screening tool which measures short term memory, visuospatial abilities, executive functions, attention, concentration and working memory, and language orientation to time and place.	From enrollment only
Body Mass Index	Body Mass Index (BMI) will be assessed to identify the moderating role of obesity on pain interference and executive function. Weight and height will be combined to report BMI in kg/m^2).	From enrollment only
Physical Performance Test Battery for Sarcopenia (1 of 6)	(1) Hand Grip Strength using a JAMAR® dynamometer, adjusted to fit participants' hands as described elsewhere. A minimum of three trials with 60 seconds of rest between trials, and additional trials if the highest two values differ by more than 3 kg. Unit: Force in kilograms The investigators will diagnose sarcopenia using the European Working Group's (EWGSOP2) revised consensus definition, which involves assessing two measures and current sarcopenia reference values: (i) hand grip strength via dynamometry and (ii) gait speed.	From enrollment to the end of treatment at 8 weeks
Physical Performance Test Battery for Sarcopenia (2 of 6)	(2) Usual Gait Speed over 4 meters to assess for gait speed. Unit: Seconds The investigators will diagnose sarcopenia using the European Working Group's (EWGSOP2) revised consensus definition, which involves assessing two measures and current sarcopenia reference values: (i) hand grip strength via dynamometry and (ii) gait speed.	From enrollment to the end of treatment at 8 weeks
Physical Performance Test Battery for Sarcopenia (3 of 6)	(3) Six Minute Walk Test to assess for submaximal aerobic walking capacity. Unit: Meters	From enrollment to the end of treatment at 8 weeks
Physical Performance Test Battery for Sarcopenia (4 of 6)	(4) Four-Square Step Test to assess for dynamic balance that involves stepping over objects forward, sideways, and backward. Unit: Seconds	From enrollment to the end of treatment at 8 weeks
Physical Performance Test Battery for Sarcopenia (5 of 6)	(5) 5x Repeated Sit-to-Stand Test to assess lower extremity strength. Unit: Seconds	From enrollment to the end of treatment at 8 weeks
Physical Performance Test Battery for Sarcopenia (6 of 6)	(6) Stair Climb Power Test to assess lower extremity power. Unit: Seconds.	From enrollment to the end of treatment at 8 weeks

Collaborators and Investigators

• Sponsor: Ohio University

Study record dates

Study Major Dates

• Study Start (Estimated): February 12, 2025
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: January 13, 2025
• First Submitted That Met QC Criteria: February 12, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 12, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Tai Chi; Cognitive Function
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Mental Disorders; Pathological Conditions, Anatomical; Neurocognitive Disorders; Cognition Disorders; Muscular Atrophy; Atrophy; Cognitive Dysfunction; Sarcopenia
• Other Study ID Numbers: Ohio_U_FY25-124

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: There is a plan to make individual participant data (IPD) collected in this study, including data dictionaries, available to other researchers after the end of the study after de-identification.
• IPD Sharing Time Frame: Immediately following publication. No end date.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No