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Recruiting NCT06828926

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

No phase Interventional Mild Cognitive Impairment (MCI) Sarcopenia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tai Chi.
Who it may be relevant to
Registry conditions: Mild Cognitive Impairment (MCI), Sarcopenia. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • 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

Primary outcome measures

  • Executive Function - Stroop Color-Word Interference Test [Time frame: From enrollment to the end of treatment at 8 weeks]
  • Executive Function - Semantic Fluency Test [Time frame: From enrollment to the end of treatment at 8 weeks]
Secondary outcome measures (7)
  • Cognitive Function - Processing Speed [Time frame: From enrollment to the end of treatment at 8 weeks]
  • Pain Interference [Time frame: From enrollment to the end of treatment at 8 weeks]
  • Social Isolation [Time frame: From enrollment to the end of treatment at 8 weeks]
  • Positive Affect [Time frame: From enrollment to the end of treatment at 8 weeks]
  • Meaning and Purpose [Time frame: From enrollment to the end of treatment at 8 weeks]
  • Heart Rate Variability [Time frame: From enrollment to the end of treatment at 8 weeks]
  • Cortical activity [Time frame: From enrollment to the end of treatment at 8 weeks]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Ohio University — Athens

Identifiers

NCT: NCT06828926 · Ohio_U_FY25-124

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗