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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06828926
Enrollment
50
Registered
2025-02-17
Start date
2025-02-12
Completion date
2026-03-31
Last updated
2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Cognitive Impairment (MCI), Sarcopenia

Keywords

Tai Chi, Cognitive Function

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.

Interventions

BEHAVIORALTai 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.

Sponsors

Ohio University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Executive Function - Stroop Color-Word Interference TestFrom enrollment to the end of treatment at 8 weeksDelis-Kaplan Executive Function System Stroop Color-Word Interference Test
Executive Function - Semantic Fluency TestFrom enrollment to the end of treatment at 8 weeksRepeatable Battery for the Assessment of Neuropsychological Status - Semantic Fluency Test

Secondary

MeasureTime frameDescription
Cognitive Function - Processing SpeedFrom enrollment to the end of treatment at 8 weeksRepeatable Battery for the Assessment of Neuropsychological Status Coding Test
Pain InterferenceFrom enrollment to the end of treatment at 8 weeksPatient Reported Outcome Measurement Information System (PROMIS) - Pain Interference Item Bank
Social IsolationFrom enrollment to the end of treatment at 8 weeksPatient Reported Outcome Measurement Information System (PROMIS) Social Isolation Item Bank
Positive AffectFrom enrollment to the end of treatment at 8 weeksPatient Reported Outcome Measurement Information System (PROMIS) Positive Affect Item Bank
Meaning and PurposeFrom enrollment to the end of treatment at 8 weeksPatient Reported Outcome Measurement Information System (PROMIS) Meaning and Purpose Item bank
Heart Rate VariabilityFrom enrollment to the end of treatment at 8 weeksHeart Rate Variability recorded while sitting for 5 minutes using a photoplethysmogram.
Cortical activityFrom enrollment to the end of treatment at 8 weeksCortical 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.

Other

MeasureTime frameDescription
Physical Performance Test Battery for Sarcopenia (1 of 6)From enrollment to the end of treatment at 8 weeks(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.
Body Mass IndexFrom enrollment onlyBody 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).
Physical Performance Test Battery for Sarcopenia (2 of 6)From enrollment to the end of treatment at 8 weeks(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.
Physical Performance Test Battery for Sarcopenia (3 of 6)From enrollment to the end of treatment at 8 weeks(3) Six Minute Walk Test to assess for submaximal aerobic walking capacity. Unit: Meters
Physical Performance Test Battery for Sarcopenia (4 of 6)From enrollment to the end of treatment at 8 weeks(4) Four-Square Step Test to assess for dynamic balance that involves stepping over objects forward, sideways, and backward. Unit: Seconds
Physical Performance Test Battery for Sarcopenia (5 of 6)From enrollment to the end of treatment at 8 weeks(5) 5x Repeated Sit-to-Stand Test to assess lower extremity strength. Unit: Seconds
Physical Performance Test Battery for Sarcopenia (6 of 6)From enrollment to the end of treatment at 8 weeks(6) Stair Climb Power Test to assess lower extremity power. Unit: Seconds.
Cognitive Assessment ScreenFrom enrollment onlyMontreal 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.

Countries

United States

Contacts

Primary ContactNicholas Karayannis, MPT, PhD
nvkaray@ohio.edu+1 740-593-1044

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026