ClinicalTrials.gg
RecruitingNCT06828926Updated Feb 17, 2025

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

An interventional study of Tai Chi in Mild Cognitive Impairment (MCI) and Sarcopenia, sponsored by Ohio University. Recruiting at 1 site in United States. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-17.

Sponsored by Ohio University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Feb 2026, 9 months ago, but the record still lists the study as recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
60 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Mild Cognitive Impairment (MCI)
  • Sarcopenia

Keywords

  • Tai Chi
  • Cognitive Function
03

In context

Cognitive Dysfunction

3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.

This study's planned enrollment of 50 is below the median of 64 across 2,794 interventional studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

Ohio University is the lead sponsor of 65 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (MoCA) will be used to classify MCI. A score above 26 is considered normal.

Exclusion criteria

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.
  1. 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 of at least 6 months before considering enrollment in the study.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • 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

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.

06

What researchers measure

Primary outcomes

  1. Executive Function - Stroop Color-Word Interference Test

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

    Time frame: From enrollment to the end of treatment at 8 weeks

  2. Executive Function - Semantic Fluency Test

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

    Time frame: From enrollment to the end of treatment at 8 weeks

Secondary outcomes

  1. Cognitive Function - Processing Speed

    Repeatable Battery for the Assessment of Neuropsychological Status Coding Test

    Time frame: From enrollment to the end of treatment at 8 weeks

  2. Pain Interference

    Patient Reported Outcome Measurement Information System (PROMIS) - Pain Interference Item Bank

    Time frame: From enrollment to the end of treatment at 8 weeks

  3. Social Isolation

    Patient Reported Outcome Measurement Information System (PROMIS) Social Isolation Item Bank

    Time frame: From enrollment to the end of treatment at 8 weeks

  4. Positive Affect

    Patient Reported Outcome Measurement Information System (PROMIS) Positive Affect Item Bank

    Time frame: From enrollment to the end of treatment at 8 weeks

  5. Meaning and Purpose

    Patient Reported Outcome Measurement Information System (PROMIS) Meaning and Purpose Item bank

    Time frame: From enrollment to the end of treatment at 8 weeks

  6. Heart Rate Variability

    Heart Rate Variability recorded while sitting for 5 minutes using a photoplethysmogram.

    Time frame: From enrollment to the end of treatment at 8 weeks

  7. 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.

    Time frame: From enrollment to the end of treatment at 8 weeks

Other outcomes

  1. 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.

    Time frame: From enrollment only

  2. 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).

    Time frame: From enrollment only

  3. 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.

    Time frame: From enrollment to the end of treatment at 8 weeks

  4. 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.

    Time frame: From enrollment to the end of treatment at 8 weeks

  5. Physical Performance Test Battery for Sarcopenia (3 of 6)

    (3) Six Minute Walk Test to assess for submaximal aerobic walking capacity. Unit: Meters

    Time frame: From enrollment to the end of treatment at 8 weeks

  6. 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

    Time frame: From enrollment to the end of treatment at 8 weeks

  7. Physical Performance Test Battery for Sarcopenia (5 of 6)

    (5) 5x Repeated Sit-to-Stand Test to assess lower extremity strength. Unit: Seconds

    Time frame: From enrollment to the end of treatment at 8 weeks

  8. Physical Performance Test Battery for Sarcopenia (6 of 6)

    (6) Stair Climb Power Test to assess lower extremity power. Unit: Seconds.

    Time frame: From enrollment to the end of treatment at 8 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

Time frame: Immediately following publication. No end date.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06828926
Lead sponsor
Ohio University
Responsible party
Sponsor
First posted
Feb 17, 2025
Start date
Feb 12, 2025 (estimated)
Primary completion
Feb 2026 (estimated)
Completion
Mar 2026 (estimated)
Last update
Feb 17, 2025

Study contacts

Nicholas Karayannis, MPT, PhD
Contact
nvkaray@ohio.edu
+1 740-593-1044

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion